Tildrakizumab SC Injection for Psoriatic Arthritis

Recruiting in Palo Alto (17 mi)

+93 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sun Pharma Global FZE

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?An open label phase 3 study

Eligibility Criteria

This trial is for patients with Psoriatic Arthritis who completed a previous study without early discontinuation. Participants must understand the study requirements, agree to follow them, and provide written consent. Women of childbearing potential must abstain from sex or use dual contraception; pregnant or breastfeeding women are excluded.

Inclusion Criteria

You have PsA and you met all the requirements for the main study, completed the treatment, and did not have to stop early for any reasons.

You must agree to comply with the study restrictions, scheduled treatments, laboratory assessments, and other study procedures

I understand what participating in this study involves.

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Exclusion Criteria

I agree to either not have heterosexual sex or use two forms of birth control.

Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.

Subject has previously been enrolled in this long-term extension study.

+1 more

Participant Groups

The trial is testing Tildrakizumab injections in an open-label phase 3 setting to evaluate its long-term safety and effectiveness in treating Psoriatic Arthritis. Patients will receive subcutaneous injections as part of their treatment regimen.

1Treatment groups

Experimental Treatment

Group I: TILD q12 weeksExperimental Treatment1 Intervention

Tildrakizumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Ilumya for: