Clinical trial NCT03897075: Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Moderate to Severe Nail Psoriasis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The Proportion of Subjects Who Achieve at Least a 75% Improvement From Baseline in Total mNAPSI at Week 28.
timeFrame: Week 28
Secondary outcomes:
measure: 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.
timeFrame: Week 28
measure: 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
timeFrame: Week 28
Other outcomes:
measure: The Percentage of Subjects With Incidence, Seriousness, and Severity of All Adverse Events.
timeFrame: Week 52
measure: 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.
timeFrame: Week 52
measure: The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix).
timeFrame: Week 52
measure: The Percentage of Subjects With Non-melanoma Skin Cancer.
timeFrame: Week 52
measure: The Percentage of Subjects With Major Adverse Cardiovascular Events.
timeFrame: Week 52
measure: The Percentage of Subjects With Melanoma Skin Cancer.
timeFrame: Week 52
measure: The Percentage of Subjects With Injection Site Reactions (eg. Pain, Erythema, Edema Etc)
timeFrame: Week 52
measure: The Percentage of Subjects With Study Treatment Related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc).
timeFrame: Week 52
Locations:
city: Encinitas
country: United States
facility: California Dermatology & CRI (Site 18)
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology (Site 07)
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates (Site 09)
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute (Site 14)
state: California
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC (Site 21)
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research (Site 23)
state: Florida
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group (Site 04)
state: New York
city: Johnston
country: United States
facility: Clinical Partners, LLC (Site 08)
state: Rhode Island
city: Cypress
country: United States
facility: Center for Clinical Studies Cypress (Site 17)
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies (Site 11)
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research (Site 27)
state: Texas
city: Kogarah
country: Australia
facility: Premier Dermatology (Site 47)
state: New South Wales
city: Kogarah
country: Australia
facility: St George Dermatology & Skin Cancer Centre (Site 45)
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research/ Specialist Connect(Site 44)
state: QSLD
city: Campbelltown
country: Australia
facility: North Eastern Health Specialists (Site 46)
state: South Australia
city: Carlton
country: Australia
facility: Skin Health Institute Inc. (Site 43)
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology (Site 40)
state: WAUS
Study officials:
References: