Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.
Condition(s) studied
Moderate to Severe Genital Psoriasis
Investigational drug(s) / intervention(s)
Tildrakizumab 100 mgPlacebo
Tildrakizumab 100 mg: Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter
Placebo: Placebo SC injection at Day 1 and Week 4
Study summary
Phase 3 study to evaluate the efficacy and safety of subcutaneous Tildrakizumab in subjects with moderate to severe genital psoriasis.
Eligibility
Inclusion Criteria:
1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines
2. Age ≥ 18 years of age at the time of signing consent
3. Diagnosis of moderate to severe psoriasis of the genital area at Screening and baseline defined as modified sPGA-G score of ≥3.
4. Presence of non-genital plaque psoriasis (BSA ≥1%) at both Screening and Baseline.
5. Presence of psoriasis of the genital area that is inadequately controlled with topical therapy or the subject is intolerant to topical therapy
6. Negative evaluation for TB within 4 weeks before initiating IMP, defined as a negative QuantiFERON test. Subjects with a positive QuantiFERON test or 2 successive indeterminate
QuantiFERON tests are allowed if they have all of the following:
* no history of active tuberculosis (TB) or symptoms of TB,
* a posteroanterior chest radiograph (with associated report available at the site) performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases),
* if prior latent TB infection, must have history of adequate prophylaxis (per local standard of care),
* if presence of latent TB is established, then treatment according to local country guidelines must have been followed for 4 weeks, prior to dosing in the study at Visit 2-Week 0.
A maximum of 2 QuantiFERON tests of no more than 3 weeks apart are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used
Exclusion Criteria:
1. Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
2. Planned surgical intervention between Baseline and the Week 16 evaluation for a pre-treatment condition.
3. Active infection or history of infections as follows:
* any active infection (bacterial, fungal or viral) for which systemic anti-infectives were used within 28 days prior to first investigational medicinal product (IMP) dose, with the last dose having been received within 7 days of Screening,
* a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening,
* recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause participation in this study to be detrimental to the subject.
4. Any concurrent medical condition or uncontrolled, clinically significant systemic disease ( e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could jeopardize subject safety or compliance with the protocol.
Primary outcome measure(s)
- Proportion of subjects with a modified sPGA-G score of clear (0) or minimal (1) with at-least a 2- point reduction from baseline — Week 16
The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4) and incorporates an assessment of the severity of the three primary signs of the disease: erythema, elevation, and scaling. Higher scores indicate greater disease severity.
Trial sites (56)
| Facility | City | Region | Status |
| Smary Cures Clinical Research |
Anaheim |
California |
|
| California Dermatology & Clinical Research Institute |
Encinitas |
California |
|
| T. Joseph Raoof MD, Inc./Encino Research Center |
Encino |
California |
|
| Center for Dermatology Clinical Research, Inc |
Fremont |
California |
|
| Dermatology Research Associates |
Los Angeles |
California |
|
| LA Universal Research Center Inc, Suite 1 |
Los Angeles |
California |
|
| Amicis Research Center |
Northridge |
California |
|
| Therapeutics Clinical Research |
San Diego |
California |
|
| Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute |
Santa Monica |
California |
|
| Paradigm Clinical Research |
Wheat Ridge |
Colorado |
|
| Coral Gables Dermatology & Aesthetics |
Coral Cables |
Florida |
|
| Florida Academic Centers Research and Education, LLC |
Coral Gables |
Florida |
|
| Homestead Associates in Research Inc |
Homestead |
Florida |
|
| Genomics Medical Research |
Miami |
Florida |
|
| Med-Care Research |
Miami |
Florida |
|
| Dermatology Affiliates Research Institute, LLC |
Atlanta |
Georgia |
|
| Mcintosh Clinic, PC |
Thomasville |
Georgia |
|
| The Indiana Clinical Trials Center |
Plainfield |
Indiana |
|
| Oakland Hills Dermatology PC |
Auburn Hills |
Michigan |
|
| The Derm Institute of West Michigan |
Caledonia |
Michigan |
|
| Skin Specialists, PC |
Omaha |
Nebraska |
|
| Forest Hills Dermatology |
Kew Gardens |
New York |
|
| Equity Medical |
New York |
New York |
|
| The Moses H. Cone Memorial Hospital Operating Corporation |
Greensboro |
North Carolina |
|
| Hickory Dermatology Research Center, LLC |
Hickory |
North Carolina |
|
| Javara Inc/ Tryon Medical Partners, PLLC |
Matthews |
North Carolina |
|
| The Indiana Clinical Trials Center Optima Research Boardman |
Boardman |
Ohio |
|
| Oregon Medical Research Center |
Portland |
Oregon |
|
| Goodlettsville Dermatology Research |
Goodlettsville |
Tennessee |
|
| Advanced Research Experts |
Nashville |
Tennessee |
|
| Arlington Research Center, inc. |
Arlington |
Texas |
|
| Center for Clinical Studies, LTD. LLP |
Houston |
Texas |
|
| Progressive Clinical Research |
San Antonio |
Texas |
|
| Texas Dermatology and Laser Specialists |
San Antonio |
Texas |
|
| Center for Clinical Studies, LTD. LLP |
Webster |
Texas |
|
| James Song, MD (James Song) |
Bellevue |
Washington |
|
| MC Medconsult-Lovech |
Lovech |
Bulgaria |
|
| Medconsult Pleven |
Pleven |
Bulgaria |
|
| JSC Curatio |
Tbilisi |
Georgia |
|
| New Vision Univestiry Hospital |
Tbilisi |
Georgia |
|
+ 16 more sites — see the full list on the official registry below.
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