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Evaluating the long-term safety and effectiveness of Tildrakizumab for psoriatic arthritis

An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.

PHASE3 · Sun Pharmaceutical Industries Limited · NCT04991116

This study is testing if Tildrakizumab is safe and effective for people with psoriatic arthritis over a long period of time.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment650 (estimated)
Ages18 Years and up
SexAll
SponsorSun Pharmaceutical Industries Limited (industry)
Locations93 sites (Dothan, Alabama and 92 other locations)
Trial IDNCT04991116 on ClinicalTrials.gov

What this trial studies

This is an open-label Phase 3 study designed to evaluate the long-term safety and efficacy of Tildrakizumab in patients with psoriatic arthritis. Participants from previous studies, INSPIRE 1 and INSPIRE 2, will continue their treatment in this long-term evaluation. The study involves subcutaneous injections of Tildrakizumab and includes regular assessments to monitor patient outcomes. The goal is to gather comprehensive data on the treatment's effectiveness over an extended period.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with psoriatic arthritis who have previously participated in the INSPIRE studies and meet all eligibility criteria.

Not a fit: Patients who are pregnant, breastfeeding, or planning to become pregnant during the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for patients suffering from psoriatic arthritis.

How similar studies have performed: Other studies have shown promising results with Tildrakizumab for psoriatic arthritis, indicating a potential for success in this long-term evaluation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Subjects possess the ability to understand the requirements of the study.
* Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.
* Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.
* Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.

Exclusion Criteria:

* Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.
* Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP.
* Subject has previously been enrolled in this long-term extension study.
* 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.

Where this trial is running

Dothan, Alabama and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Psoriatic Arthritis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.