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Scalp PsoriasisPhase 3NCT03897088

Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis

A Phase 3 study testing PART 2: Double-blind Active Treatment Extension in people with Scalp Psoriasis, run by Sun Pharmaceutical Industries Limited at 25 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe psoriasis of the scalp. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scalp Psoriasis
What is being tested?
PART 2: Double-blind Active Treatment Extension
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
231 participants
Where
25 sitesin 2 countries
Study dates
29 Mar 2019to 17 Feb 2022
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

  • Subjects should be 18 years or older at the time of signing the informed consent during the Screening visit.
  • Subjects with a clinical diagnosis of chronic plaque psoriasis of at least 6 months (as determined by-subject interview and confirmation of diagnosis through physical examination by Investigator).
  • Subjects must have moderate to severe plaque psoriasis of the scalp at Screening and at Baseline, defined by:
  • Scalp Investigator Global Assessment (IGA) of ≥3
  • Psoriasis Scalp Severity Index (PSSI) score of ≥12
  • ≥30% or scalp surface area affected.
Show all 25Show fewer
  • Subject must have moderate to severe plaque psoriasis at Screening and Baseline defined by
  • Physician Global Assessment for Skin (PGA-S) of at least moderate severity (score of ≥3 on a 5-pointer scale)
  • PASI score of ≥12
  • Body Surface Area (BSA) involvement of >10%
  • Subjects must be considered candidates for systemic therapy, meaning scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
  • Subjects has a negative evaluation for tuberculosis (TB) within 4 weeks before initiating study treatment, defined as a negative QuantiFERON® test. Subjects with a positive or 2 successive indeterminate. QuantiFERON® tests are allowed if they have all of the following:
  • No history of active TB or symptoms of TB.
  • A posterior-anterior chest radiogram (with associated report available at study center) performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases).
  • If prior latent TB infection (LTBI), must have history of adequate prophylaxis (per local standard of care).
  • If presence of LTBI is established, then treatment according to local country guidelines must have been followed for 4 weeks prior to inclusion in the study.
  • A maximum of 2 QuantiFERON® tests are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.
  • Subjects are unlikely to conceive, as indicated by at least one "Yes" answer to the following questions:
  • Subject is a male.
  • Subject is a female and agrees to abstain from heterosexual activity OR use a highly effective method of contraception as per Appendix 7.
  • Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (eg, condom) if not surgically sterile (ie, vasectomy).
  • Subject is a surgically sterilized female or is documented to be postmenopausal. For contraceptive guidance see Appendix 7.
  • For women of childbearing potential, a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to Day 1 and on subsequent visits at which study treatment doses are scheduled.
  • Subjects must have results of a physical examination within normal limits or clinically acceptable limits to the Investigator prior to Day 1. The Investigator is encouraged to consult with the Medical Monitor (or appropriate designee) if there are questions regarding the significance of any out-of-range values.
  • Subjects must be capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Who cannot join

  • Subjects who have laboratory abnormalities at Screening including any of the following:
  • Alanine aminotransferase or aspartate aminotransferase ≥2.5 × the upper limit of normal
  • Creatinine ≥2 × the upper limit of normal
  • Serum direct bilirubin ≥1.5 mg/dL
  • White blood cell count <3.0×103/μL
  • Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
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  • Subjects who have predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
  • Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the study), or are lactating.
  • Subjects with any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous (IV) antibiotics within 6 weeks prior to Screening.
  • Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
  • Prior use of TNF-alpha inhibitors with a wash-out period of 12 weeks would be allowed. However, the number of subjects with prior use of TNF-alpha inhibitors would be capped at 40% and the analysis will be stratified based on prior use of these biologics.
  • Subjects with a positive human immunodeficiency virus test result, hepatitis B surface antigen, or hepatitis C virus test result.
  • Subjects with a prior malignancy or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma of skin with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated).
  • Subjects who have received live viral or bacterial vaccination within 4-weeks prior to Baseline or who intend to receive live viral or bacterial vaccination during the study.
  • Subjects who are currently participating in another interventional clinical study or has participated in an interventional clinical study within 5-half-lives (of the drug) to wash-out prior to randomization (Subjects participating in observational studies or non-interventional registry studies may be included in the study).
  • Subjects or a family member is among the personnel of the study center or Sponsor/designee staff directly involved with this study.
  • Subjects who have any concomitant medical condition which in the opinion of the Investigator could affect the study outcome or present an unacceptable risk.
  • Subjects who were hospitalized due to an acute cardiovascular event (such as myocardial infarction, cerebrovascular accident, cardiovascular illness [eg, angina pectoris], or cardiovascular surgery [such as coronary artery bypass grafting]) within 6 months before Screening.
  • Subjects who, in the opinion of the Investigator, will not be a reliable participant in the study and those who can confound the results of the study.
  • Subjects who have a history of alcohol or drug abuse in the previous year.
  • Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment or, if appropriate, as indicated by a response of "yes" within the last 12 months to Questions 4 or 5 in the suicidal ideation section, or any positive response in the behavioral section of the Columbia-Suicide Severity Rating Scale
  • Subjects with any other clinically significant laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

United States19 sites

  • SPARC Site 01

    Beachwood, Ohio, 44122

  • SPARC Site 21

    Coral Gables, Florida, 33134

  • SPARC Site 17

    Cypress, Texas, 77433

  • SPARC Site 13

    East Windsor, New Jersey, 08520

  • SPARC Site 18

    Encinitas, California, 92024

  • SPARC Site 4

    Forest Hills, New York, 11375

  • SPARC Site 7

    Fountain Valley, California, 92708

  • SPARC Site 3

    Fremont, California, 94538

  • SPARC Site 11

    Houston, Texas, 77004

  • SPARC Site 12

    Huntington Beach, California, 92647

  • SPARC Site 8

    Johnston, Rhode Island, 02919

  • SPARC Site 9

    Los Angeles, California, 90045

  • SPARC Site 2

    Los Angeles, California, 90057

  • SPARC Site 19

    Margate, Florida, 33063

  • SPARC Site 16

    New York, New York, 10003

  • SPARC Site 20

    Portland, Oregon, 97223

  • SPARC Site 14

    Santa Monica, California, 90404

  • SPARC Site 5

    Sweetwater, Florida, 33172

  • SPARC Site 6

    Webster, Texas, 77598

Other trials in United States

Australia6 sites

  • SPARC Site 25

    Carlton, Victoria, 3053

  • SPARC Site 24

    East Melbourne, Victoria, 3002

  • SPARC Site 22

    Fremantle, Western Australia, 6160

  • SPARC Site 23

    Kogarah, New South Wales, 2217

  • SPARC Site 27

    Kogarah, New South Wales, 2217

  • SPARC Site 26

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Plaque Psoriasis of the Scalp

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe psoriasis of the scalp.

Conditions
Scalp Psoriasis
Being tested
PART 1: Double-blind Placebo-controlled, PART 2: Double-blind Active Treatment Extension

What participants receive

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

  • PART 1: Double-blind Placebo-controlledDrug

    all eligible subjects will receive either tildrakizumab or placebo

  • PART 2: Double-blind Active Treatment ExtensionDrug

    subjects initially on placebo will be switched over to receive tildrakizumab while subjects initially on tildrakizumab will continue to receive tildrakizumab as per defined schedule

Study groups in NCT03897088
Study groupRoleWhat they receive
TildrakizumabExperimentalNot described
Receives: Drug: PART 1: Double-blind Placebo-controlled; Drug: PART 2: Double-blind Active Treatment Extension
PlaceboPlacebo comparatorNot described
Receives: Drug: PART 1: Double-blind Placebo-controlled
PART 3: Observational Safety Follow-upNo interventionThe subjects will not receive study treatment during the follow-up period

What is being measured

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

  1. The Proportion of Subjects With Investigator Global Assessment Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16

    Measured: Week 16

  2. The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.

    Measured: Week 72

  3. The Percentage of Subjects With Severe Infections, Whether or Not Reported as a Serious Event

    defined as any infection meeting regulatory definition of serious adverse event, or any infection requiring intravenous antibiotics whether or not reported as a serious event as per the regulatory definition.

    Measured: Week 72

  4. The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix).

    Measured: Week 72

  5. The Percentage of Subjects With Melanoma Skin Cancer.

    Measured: Week 72

  6. The Percentage of Subjects With Major Adverse Cardiovascular Events

    Measured: Week 72

  7. The Percentage of Subjects With Study Treatment-related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc.).

    Measured: Week 72

  8. The Percentage of Subjects With Injection Site Reactions (eg, Pain, Erythema, Edema Etc).

    Measured: Week 72

  9. The Percentage of Subjects With Non-melanoma Skin Cancer

    Measured: Week 72

Secondary outcomes (22)

  1. The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index at Week 16

    Measured: Week 16

  2. Mean Percentage Change in Psoriasis Scalp Severity Index Score From Baseline to Week 16.

    Psoriasis Scalp Severity Index (PSSI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling) in the same way as the Psoriasis Area Severity Index (PASI), but for scalp only. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Lesser the score, better is the outcome.

    Measured: Week 16

  3. The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 75 at Week 16

    Psoriasis Area and Severity Index is use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling). The PASI includes scores on erythema, thickness, scaling, and percentage of body surface area (BSA) affected. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Current outcome measures proportion of subjects achieving 75% improvement from baseline.

    Measured: Week 16

  4. The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 100 at Week 16

    Psoriasis Scalp Severity Index (PSSI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling) in the same way as the Psoriasis Area Severity Index (PASI), but for scalp only. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Lesser the score, better is the outcome. Current outcome measures 100% improvement in PSSI from baseline.

    Measured: Week 16

  5. Mean Percentage Change in Scalp Surface Area (SSA) Involvement From Baseline to Week 16

    Measured: Week 16

  6. Time to 75% Reduction in Psoriasis Scalp Severity Index During 16-week Placebo-controlled Treatment Period.

    Psoriasis Scalp Severity Index (PSSI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling) in the same way as the Psoriasis Area Severity Index (PASI), but for scalp only. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline.

    Current outcome measure is time to PSSI 75. Lesser the time required, better is the effect of drug.

    Measured: Week 16

  7. Time to Investigator Global Assessment Mod 2011 (Scalp ) Response During the 16-week Placebo-controlled Treatment Period.

    Investigator Global Assessment Mod 2011 (Scalp) is a 5-point scale that is static (refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit). Score ranges from 0-4. lower the score is better. Traetment success is considered when IGA Mod 2011 (Scale) is 0 or 1 with 2 point reduction from baseline score. current outcome measures time to treatment success.

    Measured: Week 16

  8. Proportion of Subjects Achieving a 4-point Reduction in Itch Numeric Rating Scale Score From Baseline to Week 16

    Measured: Week 16

  9. The Proportion of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75, Psoriasis Area and Severity Index 90, and Psoriasis Area and Severity Index 100 at Week 16

    Psoriasis Area and Severity Index is use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling). The PASI includes scores on erythema, thickness, scaling, and percentage of body surface area (BSA) affected. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Current outcome measures proportion of subjects achieving 75%, 90% and 100% improvement from baseline, respectively.

    Measured: Week 16

  10. The Proportion of Subjects With Physician's Global Assessment Score (Whole Body) Score of "Clear" or "Almost Clear" With at Least a 2-point Reduction From Baseline to Week 16

    Measured: Week 16

  11. Mean Percentage Change in Total Body Surface Area (BSA) Involvement From Baseline to Week 16

    Measured: Week 16

  12. The Proportion of Subjects With Investigator Global Assessment (Scalp Only) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16.

    Measured: Week 16

  13. The Proportion of Subjects With Investigator Global Assessment Mod 2011 Score (Whole Body) of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16

    Measured: Week 16

  14. The Proportion of Subjects With IGA Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline

    Measured: Week 12

  15. The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index

    Measured: week 12

  16. Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52

    Measured: Week 52

  17. Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52

    Measured: Week 52

  18. Mean Change in Psoriasis Scalp Severity Index Score From Baseline at Week 52

    Psoriasis Scalp Severity Index (PSSI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling) in the same way as the Psoriasis Area Severity Index (PASI), but for scalp only. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Lesser the score, better is the outcome.

    Measured: Week 52

  19. Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52

    Measured: Week 52

  20. Change From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 52

    The Scalp Itch NRS is a self-administered, single item questionnaire with response options from 0=No Itch to 10=Worst itch imaginable. A higher score on the NRS corresponds to greater scalp itch severity.

    Measured: Week 52

  21. Mean Change in PASI Score From Baseline at Week 52

    Psoriasis Area Severity Index (PASI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling). The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Lesser the score, better is the outcome.

    Measured: Week 52

  22. Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52

    Measured: Week 52

Timeline

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

  1. First posted1 Apr 2019
  2. Study start29 Mar 2019
  3. Primary completion17 Feb 2022
  4. Study completion17 Feb 2022

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03897088
Sponsor's protocol ID
TILD-18-20
Status last verified
May 2022
First submitted
27 Mar 2019
Last updated
31 May 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sofen HL, Gogineni R, Nishandar T, Bagel J. Efficacy and Safety of Tildrakizumab for Treatment of Moderate-to-Severe Scalp Psoriasis in Patients with Obesity Over 52 Weeks. Dermatol Ther (Heidelb). 2026 Jun;16(6):3151-3165. doi: 10.1007/s13555-026-01774-2. Epub 2026 May 9.

    PubMed 42105056

  • Sofen HL, Gebauer K, Spelman L, Yamauchi PS, Yao SL, Nishandar T, Kopeloff I, Crane M, Gogineni R, Kothekar M, Bagel J. Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: Week 52 results from a phase 3b, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2025 Apr;92(4):816-824. doi: 10.1016/j.jaad.2024.12.018. Epub 2024 Dec 23.

    PubMed 39722400

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PART 2: Double-blind Active Treatment Extension in people with Scalp Psoriasis, run by Sun Pharmaceutical Industries Limited at 25 sites in 2 countries.

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 25 inclusion and 22 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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 31 May 2023). 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?

The Proportion of Subjects With Investigator Global Assessment Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16 (time frame: Week 16). The study lists 9 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 NCT03897088, which also lists 2 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 31 May 2023.

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