Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis
Study Details
Study Description
Brief Summary
Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A
|
Drug: Tildrakizumab
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
|
| Placebo Comparator: Arm B
|
Drug: Tildrakizumab
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
Drug: Placebo
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
|
Outcome Measures
Primary Outcome Measures
- The proportion of subjects with, at least, a score of "0 - normal" or "1 - minimal nail psoriasis" and a 2-point decrease from baseline as measured by the ViSENPsO. [Week 28]
Primary Efficacy Endpoint
Secondary Outcome Measures
- The proportion of subjects who achieve at least a 75% improvement from baseline in total-mNAPSI [Week 28]
- The proportion of subjects with at least 3 point decrease from baseline, in Nail Pain NRS score in subjects with baseline nail pain NRS score of >3 [Week 28]
Other Outcome Measures
- The percentage of subjects with incidence, seriousness, and severity of all adverse events. [Week 52]
Primary Safety Endpoint
- The percentage of subjects with severe infections whether or not reported as a serious event defined as any infection meeting the regulatory definition of a serious adverse event, or any infection requiring intravenous antibiotics. [Week 52]
Primary Safety Endpoint
- The percentage of subjects with malignancies (excluding carcinoma in situ of the cervix). [Week 52]
Primary Safety Endpoint
- The percentage of subjects with non-melanoma skin cancer. [Week 52]
Primary Safety Endpoint
- The percentage of subjects with Major Adverse Cardiovascular Events. [Week 52]
Primary Safety Endpoint
- The percentage of subjects with melanoma skin cancer. [Week 52]
Primary Safety Endpoint
- The percentage of subjects with injection site reactions (eg. pain, erythema, edema etc) [Week 52]
Primary Safety Endpoint
- The percentage of subjects with study treatment related hypersensitivity reactions (eg, anaphylaxis, urticaria, angioedema, etc). [Week 52]
Primary Safety Endpoint
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects are eligible to be included in the study only if all of the following criteria apply:
-
Subjects with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by Investigator).
-
Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by:
-
mNAPSI score of ≥20.
-
ViSENPsO ≥3
- Subjects must have moderate to severe plaque psoriasis at Screening and Baseline, defined by:
-
s-PGA score of at least 3.
-
Body Surface Area (BSA) involvement of ≥10%.
-
PASI ≥12
- Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
Exclusion Criteria:
Subjects are excluded from the study if any of the following criteria apply:
-
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.
-
Subjects with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment.
-
Subjects with fungal nail infection should be excluded from the study. Subjects in whom the Investigator suspects a fungal nail infection in addition to nail psoriasis should have scrapings sent for direct microscopy and fungal culture. If fungal culture or direct microscopy of nail scrapings turns out to be positive for fungal infection, the subject should be excluded from the study. At the discretion of the investigator, Periodic Acid-Schiff (PAS) staining for nail clippings could also be considered to rule of fungal infection of the nails. Direct microscopy or fungal culture are not required if fungal infection is diagnosed in PAS staining.
-
Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
-
Subjects with known history of allergy or hypersensitivity to any of the inactive ingredients of the Tildrakizumab or placebo formulations.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | California Dermatology & CRI (Site 13) | Encinitas | California | United States | 92007 |
| 2 | First OC Dermatology (Site 09) | Fountain Valley | California | United States | 92708 |
| 3 | Avance Trials (Site 14) | Laguna Niguel | California | United States | 92677 |
| 4 | Dermatology Research Associates (Site 10) | Los Angeles | California | United States | 90045 |
| 5 | Clinical Science Institute (Site 05) | Santa Monica | California | United States | 90404 |
| 6 | Florida Academic Centers Research and Education, LLC (Site 07) | Coral Gables | Florida | United States | 33134 |
| 7 | Renstar Medical Research (Site 23) | Ocala | Florida | United States | 34470 |
| 8 | Clinical Trials Management,LLC (Site 12) | Metairie | Louisiana | United States | 70006 |
| 9 | Forest Hills Dermatology Group (Site 01) | Forest Hills | New York | United States | 11375 |
| 10 | Haber Dermatology, Inc. (Site 08) | Beachwood | Ohio | United States | 44122 |
| 11 | Oregon Dermatology and Research Center (Site 11) | Portland | Oregon | United States | 97210 |
| 12 | Clinical Partners, LLC (Site 03) | Johnston | Rhode Island | United States | 02919 |
| 13 | Center for Clinical Studies Cypress (Site 06) | Cypress | Texas | United States | 77433 |
| 14 | Center for Clinical Studies (Site 04) | Houston | Texas | United States | 77004 |
| 15 | Progressive Clinical Research (Site 15) | San Antonio | Texas | United States | 78213 |
| 16 | Center for Clinical Studies, LTD.LLP (Site 02) | Webster | Texas | United States | 77598 |
| 17 | St George Dermatology & Skin Cancer Centre (Site 22) | Kogarah | New South Wales | Australia | 2217 |
| 18 | Veracity Clinical Research/ Specialist Connect(Site 19) | Woolloongabba | QSLD | Australia | 4102 |
| 19 | North Eastern Health Specialists (Site 21) | Campbelltown | South Australia | Australia | 5073 |
| 20 | Skin Health Institute Inc. (Site 18) | Carlton | Victoria | Australia | 3053 |
| 21 | Sinclair Dermatology (Site 17) | East Melbourne | Victoria | Australia | 3002 |
| 22 | Fremantle Dermatology (Site 16) | Fremantle | WAUS | Australia | 6160 |
Sponsors and Collaborators
- Sun Pharmaceutical Industries Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TILD-18-19