A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

Sun Pharmaceutical Industries Limited84 sites in 8 countries296 target enrollmentJuly 1, 2020

ConditionsActive Psoriatic Arthritis

InterventionsTILD matching placebo injections

DrugsTILD matching placebo injections

Overview

Phase: Phase 3
Intervention: TILD
Conditions: Active Psoriatic Arthritis
Sponsor: Sun Pharmaceutical Industries Limited
Enrollment: 296
Locations: 84
Primary Endpoint: The proportion of subjects who achieve American College of Rheumatology [ACR20]
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .

Registry

clinicaltrials.gov

Start Date

July 1, 2020

End Date

April 1, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Pharmaceutical Industries Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has provided written informed consent.
•Subject is ≥ 18 years of age at time of Screening.
•Subject has a diagnosis of active PsA for at least 6 months before the first administration of the study agent and has active PsA at Screening or Baseline.
•Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative.
•Subjects must have no prior exposure to anti-tumor necrosis factor (anti-TNF) agent(s) use for the treatment of PsO or PsA.

Exclusion Criteria

•The subject has a planned surgical intervention between Baseline and the Week 52 evaluation for a pretreatment condition.
•Subject has an active infection or history of infections as follows:
•any active infection for which systemic anti-infectives were used within 28 days prior to first 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 this study to be detrimental to the subject.
•Subject has 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 cause this study to be detrimental to the subject.
•Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
•Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
•Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
•Subjects with a history of alcohol or drug abuse in the previous 2 years.

Arms & Interventions

Arm A

Intervention: TILD

Arm B

Intervention: matching placebo injections

Outcomes

Primary Outcomes

The proportion of subjects who achieve American College of Rheumatology [ACR20]

Time Frame: at Week 24

the proportion of subjects achieving a 20% reduction from Baseline in response criteria

Secondary Outcomes

Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score(at Week 24)
The change from Baseline in the van der Heijde modified total Sharp score(at Week 16)
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3% those with involvement of nails, the change from Baseline in nail psoriasis severity index(at Week 52)
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis(at week 52)
The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with body surface area ≥3% at baseline(at Weeks 24)
The Change from Baseline in American College of Rheumatology Response Criteria Components Score(at Week 24)
The change from Baseline in Leeds Dactylitis Index(at Week 24)
The proportion of subjects who achieve a Disease Activity Score-C-reactive protein < 3.2(at Week 24)
The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5(Week 24)
The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5(at Week 52)
The proportion of subjects achieving American College of Rheumatology [ACR50](at Week 24)
The proportion of subjects achieving American College of Rheumatology [ACR70](at Week 24)
The change from Baseline in Leeds Enthesitis Index(at Week 24)
The proportion of subjects with active Psoriasis and body surface area ≥3%(at Week 24)
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(at Week 52)
The change from Baseline in Leeds Enthesitis Index, Leeds Dactylitis Index and Health Assessment Questionnaire Disability Index score(at Week 52)
The change from Baseline in van der Heijde modified total Sharp score(at Week 52)
The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components(measured timepoints)
The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores(at week 24)
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(at Week 24)
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)(at Week 52)
The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2(at Week 52)
The change from Baseline in anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥ 3% (those with involvement of nails)(at Week 24)
The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70](at Week 52)
The change from Baseline in American College of Rheumatology Response Criteria Components Score(at week 52)
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the proportion of subjects with Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100(at Week 52)
The change from Baseline in the van der Heijde modified total Sharp score(Week 24)
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)(at Week 24)