Plaque PsoriasisPhase 3reSURFACE 2NCT01729754

A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)

A Phase 3 study testing Tildrakizumab 200 mg, Tildrakizumab 100 mg and Etanercept 50 mg in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Plaque Psoriasis
What is being tested?: Tildrakizumab 200 mg, Tildrakizumab 100 mg and Etanercept 50 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,090 participants
Where: No sites listed yet
Study dates: 5 Feb 2013to 26 Oct 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to enrollment;
Candidate for phototherapy or systemic therapy;
Premenopausal female participants must agree to abstain from heterosexual activity or use a medically approved method of contraception or use appropriate effective contraception as per local regulations or guidelines
For the extension study: must have completed Part 3 of the base study
For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study

Who cannot join

Non-plaque forms of psoriasis
Presence or history of severe psoriatic arthritis and is well-controlled on current treatment regimen
Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
Participant is expected to require topical therapy, phototherapy, or systemic therapy during the trial
Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics
Previous use of entanercept, tildrakizumab (MK-3222), or other interleukin-23 (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including p40, p19, and IL-17 antagonists

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Latex allergy or sensitivity
Active or untreated latent tuberculosis (TB)
For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or are breast feeding
For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities
For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study

About this study

Official title: A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)

This study is being conducted to evaluate the efficacy and safety/tolerability of tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe plaque psoriasis. The primary hypotheses of the study are that tildrakizumab is superior to placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the proportion of participants achieving >= Psoriasis Area Sensitivity Index of 75% (PASI-75) response and the proportion of participants with a Physician's Global Assessment (PGA) score of "clear" or "minimal" with at least a 2 grade reduction from baseline at Week 12.

Read the detailed description

The base study consists of a screening phase of up to 4 weeks followed by a treatment period of 52 weeks, and a 20-week follow-up period. The base study treatment period is divided into 3 sequential parts.

In Part 1 of the base study (Week 0 to Week 12), participants will be randomized to one of 4 study arms (Arm A: tildrakizumab 200 mg + matching placebo to etanercept; Arm B: tildrakizumab 100 mg + matching placebo to etanercept; Arm C: matching placebo to tildrakizumab + matching placebo to etanercept; Arm D: matching placebo to tildrakizumab + etanercept 50 mg).

In Part 2 of the base study (Week 12 to Week 28), participants in Arm A and Arm B will receive matching placebo to tildrakizumab to maintain blinding at Week 12 and will receive either tildrakizumab 200 mg (Arm A) or tildrakizumab 100 mg (Arm B) at Weeks 12 and 16. Participants in Arm A and Arm B will also receive matching placebo to etanercept once weekly through study Week 28. At study Week 12, Arm C participants will be re-randomized to receive their first dose of tildrakizumab 200 mg or tildrakizumab 100 mg, and will receive additional doses of study medication according to their re-randomized treatment assignment at Week 16. Participants in Arm C will also receive matching placebo to etanercept through treatment Week 28. Participants in Arm D will continue with once weekly doses of etanercept through study Week 28 in combination with matching placebo to tildrakizumab.

In Part 3 of the base study (Week 28 to Week 52), participants in Arm A with >= PASI-75 response at Week 28 will be re-randomized to either continue tildrakizumab 200 mg or receive tildrakizumab 100 mg at study Weeks 28, 40, and 52. Participants with >= PASI-50 response but < PASI-75 response will continue to receive tildrakizumab 200 mg every 12 weeks and those participants with < PASI-50 response will be discontinued from the study. Participants in Arm B with >= PASI-75 response at Week 28 will continue to receive tildrakizumab 100 mg every 12 weeks. Those with >= PASI-50 response but < PASI-75 response will be re-randomized to receive continued tildrakizumab 100 mg or tildrakizumab 200 mg every 12 weeks. Participants in Arm B with < PASI-50 response will be discontinued from the study. Participants in Arm C will continue to receive treatment every 12 weeks according to their re-randomized treatment assignment. Participants in Arm D that achieve >= PASI-75 response at Week 28 will be discontinued from the study. Those participants with < PASI-75 response at Week 28 will be crossed over to tildrakizumab 200 mg to receive doses at Weeks 32, 36 and 48.

Eligible participants that choose to enroll in the extension study will have an additional treatment period of up to 192 weeks and will be monitored for an additional 20 weeks in the follow-up period. Each participant will receive tildrakizumab 200 mg or tildrakizumab 100 mg every 12 weeks up to study Week 244 according to their treatment assignment at the conclusion of Part 3 of the base study.

Conditions: Plaque Psoriasis
Being tested: Tildrakizumab 200 mg, Tildrakizumab 100 mg, Tildrakizumab Placebo, Etanercept Placebo, Etanercept 50 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tildrakizumab 200 mgDrug
Also called SCH 900222, MK-3222
Tildrakizumab 200 mg administered SC. Each pre-filled syringe (PFS) or autoinjector (AI) contains 1 mL of solution, tildrakizumab 100 mg/mL.
Tildrakizumab 100 mgDrug
Also called SCH 900222, MK-3222
Tildrakizumab 100 mg administered SC. Each PFS or AI contains 1 mL of solution, tildrakizumab 100 mg/mL.
Tildrakizumab PlaceboDrug
Matching placebo to tildrakizumab administered SC
Etanercept PlaceboDrug
Matching placebo to etanercept administered SC
Etanercept 50 mgDrug
Also called Embrel
Etanercept 50 mg administered SC

Study groups in NCT01729754
Study group	Role	What they receive
Tildrakizumab 200 mg	Experimental	Participants receive tildrakizumab 200 mg subcutaneously (SC) on Weeks 0, 4, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244, plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28. Receives: Drug: Tildrakizumab 200 mg; Drug: Etanercept Placebo
Tildrakizumab 100 mg	Experimental	Participants receive tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244, plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28. Receives: Drug: Tildrakizumab 100 mg; Drug: Etanercept Placebo
Placebo	Placebo comparator	Participants receive matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants will be re-randomized 1:1 at Week 12 to receive tildrakizumab 200 mg or tildrakizumab 100 mg on Weeks 12, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244. Receives: Drug: Tildrakizumab Placebo; Drug: Etanercept Placebo
Etanercept 50 mg	Active comparator	Participants receive matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who don't achieve PASI-75, receive tildrakizumab 200 mg after Week 28 (Weeks 32, 36 and 48) and, optionally, every 12 weeks thereafter until Week 244. Receives: Drug: Tildrakizumab Placebo; Drug: Etanercept 50 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
Measured: Week 12
Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1)
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
Measured: Week 12
Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to Week 12
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to Week 12

Secondary outcomes (29)

Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.
Measured: Week 28
Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 40
Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 52
Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2)
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.
Measured: Week 28
Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3)
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 40
Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3)
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 52
Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
Measured: Week 12
Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
Measured: Week 28
Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 40
Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 52
Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
Measured: Week 12
Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
Measured: Week 28
Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 40
Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 52
Baseline Dermatology Life Quality Index (DLQI)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Measured: Baseline
Change From Baseline in the DLQI at Week 12 (Part 1)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Measured: Baseline and Week 12
Change From Baseline in the DLQI at Week 28 (Part 2)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Measured: Baseline and Week 28
Change From Baseline in the DLQI at Week 40 (Part 3)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Baseline and Week 40
Change From Baseline in the DLQI at Week 52 (Part 3)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Baseline and Week 52
Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Measured: Week 12
Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Measured: Week 28
Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 40
Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Week 52
Mean Change From Baseline in PASI Score Over Time (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Measured: Baseline and Week 4, Week 8 or Week 12
Mean Change From Baseline in PASI Score Over Time (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Measured: Baseline and Week 16, Week 22 or Week 28
Mean Change From Baseline in PASI Score Over Time (Part 3)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52
Mean Percent Change From Baseline in PASI Score Over Time (Part 1)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Measured: Baseline and Week 4, Week 8 or Week 12
Mean Percent Change From Baseline in PASI Score Over Time (Part 2)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Measured: Baseline and Week 16, Week 22 or Week 28
Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.
Measured: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 201326 Oct 2021

First posted20 Nov 2012 (estimated)
Study start5 Feb 2013
Primary completion28 Sep 2015
Study completion26 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,090 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01729754
Sponsor's protocol ID: 3222-011
Other IDs: 2012-001377-88, P07771
Acronym: reSURFACE 2
Status last verified: Feb 2022
First submitted: 13 Nov 2012
Last updated: 8 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Reich K, Papp KA, Blauvelt A, Tyring SK, Sinclair R, Thaci D, Nograles K, Mehta A, Cichanowitz N, Li Q, Liu K, La Rosa C, Green S, Kimball AB. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017 Jul 15;390(10091):276-288. doi: 10.1016/S0140-6736(17)31279-5. Epub 2017 Jun 6.
PubMed 28596043
Bagel J, Gogineni R, Shaikh A, Lebwohl MG. Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis with Diabetes: Pooled Subgroup Analysis of reSURFACE 1 and reSURFACE 2. Dermatol Ther (Heidelb). 2026 Apr;16(4):2153-2167. doi: 10.1007/s13555-026-01708-y. Epub 2026 Mar 16.
PubMed 41838287
Armstrong AW, Blauvelt A, Lebwohl M, Asahina A, Gogineni R, Griffiths CEM. Efficacy and safety of tildrakizumab in patients with early- vs. late-onset psoriasis. Br J Dermatol. 2025 Aug 18;193(3):442-450. doi: 10.1093/bjd/ljaf171.
PubMed 40365708
Thaci D, Gerdes S, Du Jardin KG, Perrot JL, Puig L. Efficacy of Tildrakizumab Across Different Body Weights in Moderate-to-Severe Psoriasis Over 5 Years: Pooled Analyses from the reSURFACE Pivotal Studies. Dermatol Ther (Heidelb). 2022 Oct;12(10):2325-2341. doi: 10.1007/s13555-022-00793-z. Epub 2022 Sep 13.
PubMed 36098877
Thaci D, Piaserico S, Warren RB, Gupta AK, Cantrell W, Draelos Z, Foley P, Igarashi A, Langley RG, Asahina A, Young M, Falques M, Pau-Charles I, Mendelsohn AM, Rozzo SJ, Reich K. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021 Aug;185(2):323-334. doi: 10.1111/bjd.19866. Epub 2021 May 4.
PubMed 33544883
Kerbusch T, Li H, Wada R, Jauslin PM, Wenning L. Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. Br J Clin Pharmacol. 2020 Sep;86(9):1795-1806. doi: 10.1111/bcp.14280. Epub 2020 Mar 25.
PubMed 32162721
Elewski B, Menter A, Crowley J, Tyring S, Zhao Y, Lowry S, Rozzo S, Mendelsohn AM, Parno J, Gordon K. Sustained and continuously improved efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat. 2020 Dec;31(8):763-768. doi: 10.1080/09546634.2019.1640348. Epub 2019 Jul 22.
PubMed 31268369
Reich K, Warren RB, Iversen L, Puig L, Pau-Charles I, Igarashi A, Ohtsuki M, Falques M, Harmut M, Rozzo S, Lebwohl MG, Cantrell W, Blauvelt A, Thaci D. Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks. Br J Dermatol. 2020 Mar;182(3):605-617. doi: 10.1111/bjd.18232. Epub 2019 Jul 18.
PubMed 31218661
Jauslin P, Kulkarni P, Li H, Vatakuti S, Hussain A, Wenning L, Kerbusch T. Population-Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-Interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis. Clin Pharmacokinet. 2019 Aug;58(8):1059-1068. doi: 10.1007/s40262-019-00743-7.
PubMed 30915660

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
Psoriasis, Moderate to Severe Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque Psoriasis
RecruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
Psoriasis, Healthy

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)
ClinicalTrials.gov ID: NCT01729754
Acronym / sponsor ID: reSURFACE 2 / 3222-011
Conditions: Plaque Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,090 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
Study start: 5 Feb 2013 (actual)
Primary completion: 28 Sep 2015 (actual)
Study completion: 26 Oct 2021 (actual)
First posted: 20 Nov 2012 (estimated)
Results: Posted 27 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Tildrakizumab 200 mg	Experimental	Drug: Tildrakizumab 200 mg, Drug: Etanercept PlaceboParticipants receive tildrakizumab 200 mg subcutaneously (SC) on Weeks 0, 4, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244, plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Tildrakizumab 100 mg	Experimental	Drug: Tildrakizumab 100 mg, Drug: Etanercept PlaceboParticipants receive tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244, plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Placebo	Placebo comparator	Drug: Tildrakizumab Placebo, Drug: Etanercept PlaceboParticipants receive matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants will be re-randomized 1:1 at Week 12 to receive tildrakizumab 200 mg or tildrakizumab 100 mg on Weeks 12, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244.
Etanercept 50 mg	Active comparator	Drug: Tildrakizumab Placebo, Drug: Etanercept 50 mgParticipants receive matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who don't achieve PASI-75, receive tildrakizumab 200 mg after Week 28 (Weeks 32, 36 and 48) and, optionally, every 12 weeks thereafter until Week 244.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to enrollment;
Candidate for phototherapy or systemic therapy;
Premenopausal female participants must agree to abstain from heterosexual activity or use a medically approved method of contraception or use appropriate effective contraception as per local regulations or guidelines
For the extension study: must have completed Part 3 of the base study
For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study

Key exclusion criteria (11 listed)

Non-plaque forms of psoriasis
Presence or history of severe psoriatic arthritis and is well-controlled on current treatment regimen
Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
Participant is expected to require topical therapy, phototherapy, or systemic therapy during the trial
Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tildrakizumab 200 mgAlso: SCH 900222, MK-3222Tildrakizumab 200 mg administered SC. Each pre-filled syringe (PFS) or autoinjector (AI) contains 1 mL of solution, tildrakizumab 100 mg/mL.	Drug	Tildrakizumab 200 mg
Tildrakizumab 100 mgAlso: SCH 900222, MK-3222Tildrakizumab 100 mg administered SC. Each PFS or AI contains 1 mL of solution, tildrakizumab 100 mg/mL.	Drug	Tildrakizumab 100 mg
Tildrakizumab PlaceboMatching placebo to tildrakizumab administered SC	Drug	Etanercept 50 mg, Placebo
Etanercept PlaceboMatching placebo to etanercept administered SC	Drug	Placebo, Tildrakizumab 100 mg, Tildrakizumab 200 mg
Etanercept 50 mgAlso: EmbrelEtanercept 50 mg administered SC	Drug	Etanercept 50 mg

Primary outcome

Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)
Time frame: Week 12
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1)
Time frame: Week 12
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.
Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)
Time frame: Up to Week 12
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)
Time frame: Up to Week 12
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

29 secondary outcomes

Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)
Time frame: Week 28
Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)
Time frame: Week 40
Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)
Time frame: Week 52
Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2)
Time frame: Week 28
Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3)
Time frame: Week 40
Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3)
Time frame: Week 52
Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)
Time frame: Week 12
Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)
Time frame: Week 28
Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)
Time frame: Week 40
Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)
Time frame: Week 52
Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)
Time frame: Week 12
Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)
Time frame: Week 28
Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)
Time frame: Week 40
Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)
Time frame: Week 52
Baseline Dermatology Life Quality Index (DLQI)
Time frame: Baseline
Change From Baseline in the DLQI at Week 12 (Part 1)
Time frame: Baseline and Week 12
Change From Baseline in the DLQI at Week 28 (Part 2)
Time frame: Baseline and Week 28
Change From Baseline in the DLQI at Week 40 (Part 3)
Time frame: Baseline and Week 40
Change From Baseline in the DLQI at Week 52 (Part 3)
Time frame: Baseline and Week 52
Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)
Time frame: Week 12
Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)
Time frame: Week 28
Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)
Time frame: Week 40
Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)
Time frame: Week 52
Mean Change From Baseline in PASI Score Over Time (Part 1)
Time frame: Baseline and Week 4, Week 8 or Week 12
Mean Change From Baseline in PASI Score Over Time (Part 2)
Time frame: Baseline and Week 16, Week 22 or Week 28
Mean Change From Baseline in PASI Score Over Time (Part 3)
Time frame: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52
Mean Percent Change From Baseline in PASI Score Over Time (Part 1)
Time frame: Baseline and Week 4, Week 8 or Week 12
Mean Percent Change From Baseline in PASI Score Over Time (Part 2)
Time frame: Baseline and Week 16, Week 22 or Week 28
Mean Percent Change From Baseline in PASI Score Over Time (Part 3)
Time frame: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52

Results and safety

Results posted to the registry on 27 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tildrakizumab 200 mg (Parts 1 & 2)	20	6
Tildrakizumab 200 mg (Parts 1, 2, & 3)	184	184
Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3)	110	110
Tildrakizumab 100 mg (Parts 1 & 2)	18	6
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3)	21	21
Tildrakizumab 100 mg (Parts 1, 2, & 3)	268	268
Placebo (Part 1)	14	0
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)	72	72
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)	70	70
Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)	313	289

Primary outcome: Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)

Time frame: Week 12. Number. Unit: Percentage of participants

Measure	Tildrakizumab 200 mg n = 314	Tildrakizumab 100 mg n = 307	Placebo n = 156	Etanercept 50 mg n = 313
Value	65.6	61.2	5.8	48.2

Tildrakizumab 200 mg vs Placebo: Difference in percentages: 59.8 (95% CI 52.9 to 65.9), p <0.001, Cochran-Mantel-Haenszel
Tildrakizumab 100 mg vs Placebo: Difference in percentages: 55.5 (95% CI 48.3 to 61.8), p <0.001, Cochran-Mantel-Haenszel

Population analysed: Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.

Primary outcome: Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1)

Time frame: Week 12. Number. Unit: Percentage of participants

Measure	Tildrakizumab 200 mg n = 314	Tildrakizumab 100 mg n = 307	Placebo n = 156	Etanercept 50 mg n = 313
Value	59.2	54.7	4.5	47.6

Tildrakizumab 200 mg vs Placebo: Difference in percentages: 54.7 (95% CI 47.9 to 60.8), p <0.001, Cochran-Mantel-Haenszel
Tildrakizumab 100 mg vs Placebo: Difference in percentages: 50.2 (95% CI 43.2 to 56.5), p <0.001, Cochran-Mantel-Haenszel

Population analysed: Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.

Primary outcome: Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)

Time frame: Up to Week 12. Number. Unit: Percentage of participants

Measure	Tildrakizumab 200 mg n = 314	Tildrakizumab 100 mg n = 307	Placebo n = 156	Etanercept 50 mg n = 313
Value	49.4	44.3	55.1	54.0

Population analysed: Analysis population includes participants who took at least one dose of Part 1 study drug based on the treatment actually received.

Primary outcome: Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)

Time frame: Up to Week 12. Number. Unit: Percentage of participants

Measure	Tildrakizumab 200 mg n = 314	Tildrakizumab 100 mg n = 307	Placebo n = 156	Etanercept 50 mg n = 313
Value	1.0	1.0	1.3	1.9

Population analysed: Analysis population includes participants who took at least one dose of Part 1 study medication based on the treatment actually received.

29 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 52 weeks (Part 1: Weeks 0-12; Part 2: Weeks 12-28; Part 3: Weeks 28-52). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R	26 of 527 (4.9%)	167 of 527 (31.7%)	0 of 527
Tildrakizumab 100 mg (Parts 1, 2 & 3)	30 of 487 (6.2%)	151 of 487 (31%)	3 of 487
Placebo (Part 1)	4 of 156 (2.6%)	23 of 156 (14.7%)	0 of 156
Etanercept 50 mg (Parts 1 & 2)	20 of 313 (6.4%)	118 of 313 (37.7%)	0 of 313

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28596043Reich K, Papp KA, Blauvelt A, Tyring SK, Sinclair R, Thaci D, Nograles K, Mehta A, Cichanowitz N, Li Q, Liu K, La Rosa C, Green S, Kimball AB. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017 Jul 15;390(10091):276-288. doi: 10.1016/S0140-6736(17)31279-5. Epub 2017 Jun 6.
Derived from this study: PubMed 41838287Bagel J, Gogineni R, Shaikh A, Lebwohl MG. Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis with Diabetes: Pooled Subgroup Analysis of reSURFACE 1 and reSURFACE 2. Dermatol Ther (Heidelb). 2026 Apr;16(4):2153-2167. doi: 10.1007/s13555-026-01708-y. Epub 2026 Mar 16.
Derived from this study: PubMed 40365708Armstrong AW, Blauvelt A, Lebwohl M, Asahina A, Gogineni R, Griffiths CEM. Efficacy and safety of tildrakizumab in patients with early- vs. late-onset psoriasis. Br J Dermatol. 2025 Aug 18;193(3):442-450. doi: 10.1093/bjd/ljaf171.
Derived from this study: PubMed 36098877Thaci D, Gerdes S, Du Jardin KG, Perrot JL, Puig L. Efficacy of Tildrakizumab Across Different Body Weights in Moderate-to-Severe Psoriasis Over 5 Years: Pooled Analyses from the reSURFACE Pivotal Studies. Dermatol Ther (Heidelb). 2022 Oct;12(10):2325-2341. doi: 10.1007/s13555-022-00793-z. Epub 2022 Sep 13.
Derived from this study: PubMed 33544883Thaci D, Piaserico S, Warren RB, Gupta AK, Cantrell W, Draelos Z, Foley P, Igarashi A, Langley RG, Asahina A, Young M, Falques M, Pau-Charles I, Mendelsohn AM, Rozzo SJ, Reich K. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021 Aug;185(2):323-334. doi: 10.1111/bjd.19866. Epub 2021 May 4.
Derived from this study: PubMed 32162721Kerbusch T, Li H, Wada R, Jauslin PM, Wenning L. Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. Br J Clin Pharmacol. 2020 Sep;86(9):1795-1806. doi: 10.1111/bcp.14280. Epub 2020 Mar 25.
Derived from this study: PubMed 31268369Elewski B, Menter A, Crowley J, Tyring S, Zhao Y, Lowry S, Rozzo S, Mendelsohn AM, Parno J, Gordon K. Sustained and continuously improved efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat. 2020 Dec;31(8):763-768. doi: 10.1080/09546634.2019.1640348. Epub 2019 Jul 22.
Derived from this study: PubMed 31218661Reich K, Warren RB, Iversen L, Puig L, Pau-Charles I, Igarashi A, Ohtsuki M, Falques M, Harmut M, Rozzo S, Lebwohl MG, Cantrell W, Blauvelt A, Thaci D. Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks. Br J Dermatol. 2020 Mar;182(3):605-617. doi: 10.1111/bjd.18232. Epub 2019 Jul 18.
Derived from this study: PubMed 30915660Jauslin P, Kulkarni P, Li H, Vatakuti S, Hussain A, Wenning L, Kerbusch T. Population-Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-Interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis. Clin Pharmacokinet. 2019 Aug;58(8):1059-1068. doi: 10.1007/s40262-019-00743-7.

Related trials for Plaque Psoriasis

Active, not recruitingObservational study
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tildrakizumab 200 mg, Tildrakizumab 100 mg and Etanercept 50 mg in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) (time frame: Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01729754, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.