Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

Chronic Plaque Psoriasis Clinical Trial

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 Nail Psoriasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03897075
• Other study ID #: TILD-18-19
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 13, 2021
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: February 2025
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects are eligible to be included in the study only if all of the following criteria apply:

1. 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).

2. Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by:

• mNAPSI score of =20.

• ViSENPsO =3

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

4. 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:

1. 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.

2. 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.

3. 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.

4. Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.

5. Subjects with known history of allergy or hypersensitivity to any of the inactive ingredients of the Tildrakizumab or placebo formulations.

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Moderate to Severe Nail Psoriasis
• Psoriasis

Intervention

Drug:
• Tildrakizumab
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
• Placebo
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up

Locations

Country	Name	City	State
Australia	North Eastern Health Specialists (Site 46)	Campbelltown	South Australia
Australia	Skin Health Institute Inc. (Site 43)	Carlton	Victoria
Australia	Fremantle Dermatology (Site 40)	Fremantle	WAUS
Australia	Premier Dermatology (Site 47)	Kogarah	New South Wales
Australia	St George Dermatology & Skin Cancer Centre (Site 45)	Kogarah	New South Wales
Australia	Veracity Clinical Research/ Specialist Connect(Site 44)	Woolloongabba	QSLD
United States	Florida Academic Centers Research and Education, LLC (Site 21)	Coral Gables	Florida
United States	Center for Clinical Studies Cypress (Site 17)	Cypress	Texas
United States	Forest Hills Dermatology Group (Site 04)	Forest Hills	New York
United States	First OC Dermatology (Site 07)	Fountain Valley	California
United States	Center for Clinical Studies (Site 11)	Houston	Texas
United States	Clinical Partners, LLC (Site 08)	Johnston	Rhode Island
United States	Dermatology Research Associates (Site 09)	Los Angeles	California
United States	Renstar Medical Research (Site 23)	Ocala	Florida
United States	Progressive Clinical Research (Site 27)	San Antonio	Texas
United States	Clinical Science Institute (Site 14)	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The percentage of subjects with incidence, seriousness, and severity of all adverse events.	Primary Safety Endpoint	Week 52
Other	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.	Primary Safety Endpoint	Week 52
Other	The percentage of subjects with malignancies (excluding carcinoma in situ of the cervix).	Primary Safety Endpoint	Week 52
Other	The percentage of subjects with non-melanoma skin cancer.	Primary Safety Endpoint	Week 52
Other	The percentage of subjects with Major Adverse Cardiovascular Events.	Primary Safety Endpoint	Week 52
Other	The percentage of subjects with melanoma skin cancer.	Primary Safety Endpoint	Week 52
Other	The percentage of subjects with injection site reactions (eg. pain, erythema, edema etc)	Primary Safety Endpoint	Week 52
Other	The percentage of subjects with study treatment related hypersensitivity reactions (eg, anaphylaxis, urticaria, angioedema, etc).	Primary Safety Endpoint	Week 52
Primary	The proportion of subjects who achieve at least a 75% improvement from baseline in totalmNAPSI at Week 28.	Primary Efficacy Endpoint	Week 28
Secondary	The proportion of subjects with a score of "0 - normal" or "1 - minimal nail psoriasis" and at least a 2-point decrease from baseline at Week 28 as measured by the ViSENPsO.		Week 28
Secondary	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