Plaque-type PsoriasisPhase 3NCT01936688
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous MK-3222 in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-012)
A Phase 3 study testing MK-3222 200 mg, MK-3222 100 mg and Etanercept 50 mg in people with Plaque-type Psoriasis, run by Sun Pharmaceutical Industries Limited.
Trial summary
This study is being conducted to evaluate the efficacy and safety/tolerability of SCH 900222/MK-3222 in a population of participants with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque-type Psoriasis
- What is being tested?
- MK-3222 200 mg, MK-3222 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 of the base study
- For the extension study: must have achieved at least a PASI-50 response by the end of Part 2 of the base study
Who cannot join
- Non-plaque forms of psoriasis
- Presence or history of severe psoriatic arthritis that is well-controlled on current treatment regimen
- Women of childbearing potential that are pregnant, intend to become pregnant, or are lactating
- Participant is expected to require topical therapy, phototherapy, or systemic therapy
- Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics
- Previous use of MK-3222/SCH 900222, or other interleukin-23 (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including P40, P19, and IL-17 antagonists, or etanercept
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- Latex allergy or sensitivity
- Active or untreated latent tuberculosis (TB)
- For the extension study: women of child-bearing potential that are pregnant, intend to become pregnant within 6 months of completing the trial, or that 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 28-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous 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-3222-012)
This study is being conducted to evaluate the efficacy and safety/tolerability of SCH 900222/MK-3222 in a population of participants with moderate-to-severe plaque psoriasis.
Read the detailed description
The base study consists of a screening phase of up to 4 weeks followed by a treatment period of 28 weeks, and a 20-week safety follow-up period off drug. The base study is divided into 2 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: MK-3222 200 mg at Week 0 and Week 4 + matching placebo to etanercept twice weekly; Arm B: MK-3222 100 mg at Week 0 and Week 4 + matching placebo to etanercept twice weekly; Arm C: Matching placebo to MK-3222 at Week 0 and Week 4 + matching placebo to etanercept twice weekly; Arm D: Matching placebo to MK-3222 at Week 0 and Week 4 + etanercept 50 mg twice weekly).
In Part 2 of the base study (Week 12 to Week 28), participants in Arm A, Arm B, and Arm D will receive matching placebo to MK-3222 to maintain blinding at Week 12. Participants in Arm A and Arm B will continue to receive either MK-3222 200 mg (Arm A) or MK-3222 100 mg (Arm B) at Week 16 and Week 28 and 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 MK-3222 200 mg or MK-3222 100 mg, and will receive additional doses of study medication according to their re-randomized treatment assignment at Week 16 and Week 28. Participants in Arm C will also receive matching placebo to etanercept once weekly 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 MK-3222.
For all participants, completion of Week 28 marks completion of Part 2 and of the overall base study. Participants originally assigned to Arm D and participants who discontinue treatment prior to completing Part 2 will not be eligible to enroll in the extension. Participants that are ineligible or opt not to enter the extension study will be encouraged to complete the 20-week follow-up period.
Eligible participants that choose to enroll in the extension study will have an additional treatment period of up to 192 weeks and will be followed for an additional 20 weeks in the follow-up period. Each participant will receive MK-3222 200 mg or MK-3222 100 mg every 12 weeks up to study Week 220 according to their treatment assignment at the conclusion of Part 2 of the base study.
- Conditions
- Plaque-type Psoriasis
- Being tested
- MK-3222 200 mg, MK-3222 100 mg, Placebo to MK-3222, Placebo to Etanercept, Etanercept 50 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-3222 200 mgDrug
MK-3222 200 mg administered SC.
MK-3222 100 mgDrug
MK-3222 100 mg administered SC.
Placebo to MK-3222Drug
Matching placebo to MK-3222 administered SC.
Placebo to EtanerceptDrug
Matching placebo to etanercept for subcutaneous injection.
Etanercept 50 mgDrug
Etanercept 50 mg for subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| MK-3222 200 mg + Placebo to Etanercept | Experimental | MK-3222 200 mg subcutaneously (SC) on Weeks 0, 4, 16, and 28 and, optionally, every 12 weeks thereafter until Week 220, plus etanercept placebo twice weekly up to Week 12, and then once weekly through Week 28. Receives: Drug: MK-3222 200 mg; Drug: Placebo to Etanercept |
| MK-3222 100 mg + Placebo to Etanercept | Experimental | MK-3222 100 mg SC on Weeks 0, 4, 16, and 28 and, optionally, every 12 weeks thereafter until Week 220, plus etanercept placebo twice weekly up to Week 12, and then once weekly through Week 28. Receives: Drug: MK-3222 100 mg; Drug: Placebo to Etanercept |
| Placebo to MK-3222 + Placebo to Etanercept | Placebo comparator | Placebo to MK-3222 administered SC on Weeks 0 and 4 plus etanercept placebo twice weekly up to Week 12, then once weekly up to Week 28. Participants will be re-randomized 1:1 at Week 12 to receive MK-3222 high dose or MK-3222 low dose on Weeks 12, 16, and 28 and, optionally, every 12 weeks thereafter through Week 220. Receives: Drug: Placebo to MK-3222; Drug: Placebo to Etanercept |
| Placebo to MK-3222 + Etanercept 50 mg | Active comparator | Matching placebo to MK-3222 SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and then once weekly through Week 28. Receives: Drug: Placebo to MK-3222; Drug: Etanercept 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving a Psoriasis Area Severity Index 75% (PASI-75) at Week 12
Measured: Week 12
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
Measured: Baseline, Week 12
Secondary outcomes (8)
Proportion of Participants Achieving PASI-90 Response at Week 12 and 28
Measured: Week 12, Week 28
Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 12 and Week 28
Measured: Week 12, Week 28
Proportion of Participants With a DLQI Score of 0 or 1 at Week 12 and Week 28
Measured: Week 12, Week 28
Mean Change and Mean Percent Change from Baseline in PASI Score Over Time
Measured: Baseline, Up to Week 28
Mean Change From Baseline in the Nail Area Psoriasis Severity Index (NAPSI) at Week 12 and Week 28
Measured: Week 12, Week 28
Number of Participants Experiencing an Adverse Event (AE)
Measured: Up to Week 28
Number of Participants Discontinuing Study Treatment Due to an AE
Measured: Up to Week 28
Proportion of Participants Achieving PASI-100 Response at Week 12 and 28
Measured: Week 12, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque-type 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936688
- Sponsor's protocol ID
- 3222-012
- Other IDs
- MK-3222-012, 2013-001740-54
- Status last verified
- Feb 2022
- First submitted
- 3 Sep 2013
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous 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-3222-012)
- ClinicalTrials.gov ID
- NCT01936688
- Acronym / sponsor ID
- 3222-012
- Conditions
- Plaque-type Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the efficacy and safety/tolerability of SCH 900222/MK-3222 in a population of participants with moderate-to-severe plaque psoriasis.
Detailed description
The base study consists of a screening phase of up to 4 weeks followed by a treatment period of 28 weeks, and a 20-week safety follow-up period off drug. The base study is divided into 2 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: MK-3222 200 mg at Week 0 and Week 4 + matching placebo to etanercept twice weekly; Arm B: MK-3222 100 mg at Week 0 and Week 4 + matching placebo to etanercept twice weekly; Arm C: Matching placebo to MK-3222 at Week 0 and Week 4 + matching placebo to etanercept twice weekly; Arm D: Matching placebo to MK-3222 at Week 0 and Week 4 + etanercept 50 mg twice weekly).
In Part 2 of the base study (Week 12 to Week 28), participants in Arm A, Arm B, and Arm D will receive matching placebo to MK-3222 to maintain blinding at Week 12. Participants in Arm A and Arm B will continue to receive either MK-3222 200 mg (Arm A) or MK-3222 100 mg (Arm B) at Week 16 and Week 28 and 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 MK-3222 200 mg or MK-3222 100 mg, and will receive additional doses of study medication according to their re-randomized treatment assignment at Week 16 and Week 28. Participants in Arm C will also receive matching placebo to etanercept once weekly 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 MK-3222.
For all participants, completion of Week 28 marks completion of Part 2 and of the overall base study. Participants originally assigned to Arm D and participants who discontinue treatment prior to completing Part 2 will not be eligible to enroll in the extension. Participants that are ineligible or opt not to enter the extension study will be encouraged to complete the 20-week follow-up period.
Eligible participants that choose to enroll in the extension study will have an additional treatment period of up to 192 weeks and will be followed for an additional 20 weeks in the follow-up period. Each participant will receive MK-3222 200 mg or MK-3222 100 mg every 12 weeks up to study Week 220 according to their treatment assignment at the conclusion of Part 2 of the base study.
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 |
|---|---|---|
| MK-3222 200 mg + Placebo to Etanercept | Experimental | Drug: MK-3222 200 mg, Drug: Placebo to EtanerceptMK-3222 200 mg subcutaneously (SC) on Weeks 0, 4, 16, and 28 and, optionally, every 12 weeks thereafter until Week 220, plus etanercept placebo twice weekly up to Week 12, and then once weekly through Week 28. |
| MK-3222 100 mg + Placebo to Etanercept | Experimental | Drug: MK-3222 100 mg, Drug: Placebo to EtanerceptMK-3222 100 mg SC on Weeks 0, 4, 16, and 28 and, optionally, every 12 weeks thereafter until Week 220, plus etanercept placebo twice weekly up to Week 12, and then once weekly through Week 28. |
| Placebo to MK-3222 + Placebo to Etanercept | Placebo comparator | Drug: Placebo to MK-3222, Drug: Placebo to EtanerceptPlacebo to MK-3222 administered SC on Weeks 0 and 4 plus etanercept placebo twice weekly up to Week 12, then once weekly up to Week 28. Participants will be re-randomized 1:1 at Week 12 to receive MK-3222 high dose or MK-3222 low dose on Weeks 12, 16, and 28 and, optionally, every 12 weeks thereafter through Week 220. |
| Placebo to MK-3222 + Etanercept 50 mg | Active comparator | Drug: Placebo to MK-3222, Drug: Etanercept 50 mgMatching placebo to MK-3222 SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and then once weekly through Week 28. |
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 2 of the base study
- For the extension study: must have achieved at least a PASI-50 response by the end of Part 2 of the base study
Key exclusion criteria (11 listed)
- Non-plaque forms of psoriasis
- Presence or history of severe psoriatic arthritis that is well-controlled on current treatment regimen
- Women of childbearing potential that are pregnant, intend to become pregnant, or are lactating
- Participant is expected to require topical therapy, phototherapy, or systemic therapy
- 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 |
|---|---|---|
| MK-3222 200 mgMK-3222 200 mg administered SC. | Drug | MK-3222 200 mg + Placebo to Etanercept |
| MK-3222 100 mgMK-3222 100 mg administered SC. | Drug | MK-3222 100 mg + Placebo to Etanercept |
| Placebo to MK-3222Matching placebo to MK-3222 administered SC. | Drug | Placebo to MK-3222 + Etanercept 50 mg, Placebo to MK-3222 + Placebo to Etanercept |
| Placebo to EtanerceptMatching placebo to etanercept for subcutaneous injection. | Drug | MK-3222 100 mg + Placebo to Etanercept, MK-3222 200 mg + Placebo to Etanercept, Placebo to MK-3222 + Placebo to Etanercept |
| Etanercept 50 mgEtanercept 50 mg for subcutaneous injection. | Drug | Placebo to MK-3222 + Etanercept 50 mg |
Primary outcome
Proportion of Participants Achieving a Psoriasis Area Severity Index 75% (PASI-75) at Week 12
Time frame: Week 12
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
Time frame: Baseline, Week 12
8 secondary outcomes
Proportion of Participants Achieving PASI-90 Response at Week 12 and 28
Time frame: Week 12, Week 28
Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 12 and Week 28
Time frame: Week 12, Week 28
Proportion of Participants With a DLQI Score of 0 or 1 at Week 12 and Week 28
Time frame: Week 12, Week 28
Mean Change and Mean Percent Change from Baseline in PASI Score Over Time
Time frame: Baseline, Up to Week 28
Mean Change From Baseline in the Nail Area Psoriasis Severity Index (NAPSI) at Week 12 and Week 28
Time frame: Week 12, Week 28
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to Week 28
Number of Participants Discontinuing Study Treatment Due to an AE
Time frame: Up to Week 28
Proportion of Participants Achieving PASI-100 Response at Week 12 and 28
Time frame: Week 12, Week 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
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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 MK-3222 200 mg, MK-3222 100 mg and Etanercept 50 mg in people with Plaque-type 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: withdrawn, as of the sponsor's last update on 24 Feb 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of Participants Achieving a Psoriasis Area Severity Index 75% (PASI-75) at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2022.