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Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2) | Clinical Trials | Clareo Health

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Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

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)

NCT04314531•Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

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 .

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has provided written informed consent.
•2. Subject is ≥ 18 years of age at time of Screening.
•3. 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.
•4. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative.
•5. 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

•1. The subject has a planned surgical intervention between Baseline and the Week 52 evaluation for a pretreatment condition.
•2. 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.
•3. 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.
•4. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
•5. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
•6. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
•7. Subjects with a history of alcohol or drug abuse in the previous 2 years.
+7 more criteria

Locations (49)

Sunpharma site no. 12

Covina, California, United States

Sunpharma site no. 04

Miami Beach, Florida, United States

Sunpharma site no. 02

New Port Richey, Florida, United States

Sunpharma site no. 07

Tamarac, Florida, United States

Sunpharma site no. 05

Springfield, Missouri, United States

Sunpharma site no. 10

Lincoln, Nebraska, United States

Sunpharma site no. 11

Greenville, South Carolina, United States

Sunpharma site no. 09

Lubbock, Texas, United States

Sunpharma site no. 03

San Antonio, Texas, United States

Sunpharma site no. 01

Tomball, Texas, United States

Key Dates

Start Date

July 1, 2020

Primary Completion Date

June 4, 2025

Completion Date

April 1, 2026

Last Updated

March 10, 2026

Enrollment

296

ACTUAL participants

Conditions

Active Psoriatic Arthritis

Interventions

TILD

DRUG

matching placebo injections

DRUG