Tildrakizumab for Psoriatic Arthritis

Recruiting at 108 trial locations

Overseen By Head, Clinical development

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sun Pharma Global FZE

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing tildrakizumab, a medication that reduces inflammation, in patients with active Psoriatic Arthritis who haven't tried certain other treatments. It works by blocking a protein to help manage symptoms. Tildrakizumab is approved for treating moderate to severe plaque psoriasis.

Eligibility Criteria

This trial is for adults diagnosed with active Psoriatic Arthritis (PsA) for at least 6 months, who have never used anti-TNF treatments. Participants must test negative for certain antibodies and agree to use effective contraception if of childbearing potential. Exclusions include a history of serious infections, heart issues within the past 6 months, drug abuse in the last two years, or any condition that might compromise study participation.

Inclusion Criteria

I have never used anti-TNF drugs for psoriasis or psoriatic arthritis.

Subject has provided written informed consent.

I have been diagnosed with active Psoriatic Arthritis for at least 6 months.

Exclusion Criteria

I do not have any severe health issues that could make this study unsafe for me.

I have an active cancer, including skin cancers like basal or squamous cell carcinoma or melanoma.

I am not currently institutionalized by court or government order.

Treatment Details

Interventions

• Tildrakizumab (Monoclonal Antibodies)

Trial Overview The INSPIRE 2 study is testing the effectiveness and safety of Tildrakizumab (TILD), an investigational medication, against a placebo in individuals who haven't previously been treated with anti-TNF drugs. This Phase 3 trial randomly assigns participants to receive either TILD or placebo injections without knowing which one they're getting.

Participant Groups

Group I: Arm A Experimental Treatment 1 Intervention

Group II: Arm B Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Sun Pharma Global FZE

Lead Sponsor

Trials

34

Recruited

10,200+

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution