Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

Running, not enrolling · Phase 3

Conditions studied: Psoriatic Arthritis

In brief

An open label phase 3 study

Key facts

Study ID

NCT04991116

Run by

Sun Pharmaceutical Industries Limited

People needed

529

Starts

2022-06-30

Expected to finish

2029-04-01

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Sunpharma site no 80 — Gilbert, Arizona, United States
• Sunpharma site no 65 — Mesa, Arizona, United States
• Sunpharma site no 105 — Phoenix, Arizona, United States
• Sunpharma site no. 30 — Covina, California, United States
• Sunpharma site no 110 — Encino, California, United States
• Sunpharma site no. 17 — Fountain Valley, California, United States
• Sunpharma site no. 15 — Thousand Oaks, California, United States
• Sunpharma site no 113 — Avon Park, Florida, United States
• Sunpharma site no. 21 — Clearwater, Florida, United States
• Sunpharma site no. 02 — Hialeah, Florida, United States
• Sunpharma site no 71 — Kissimmee, Florida, United States
• Sunpharma site no 107 — Margate, Florida, United States
• Sunpharma site no. 05 — New Port Richey, Florida, United States
• Sunpharma site no 32 — Ocoee, Florida, United States
• SunPharma Site no 22 — Tamarac, Florida, United States
• Sunpharma site no 52 — Gainesville, Georgia, United States
• Sunpharma site no 51 — Orland Park, Illinois, United States
• Sunpharma site no 49 — Schaumburg, Illinois, United States
• Sunpharma site no 47 — Skokie, Illinois, United States
• Sunpharma site no. 20 — Wichita, Kansas, United States
• Sunpharma site no. 14 — Springfield, Missouri, United States
• Sunpharma site no 104 — St Louis, Missouri, United States
• Sunpharma site no 48 — Kalispell, Montana, United States
• Sunpharma Site no 27 — Lincoln, Nebraska, United States
• Sunpharma site no 50 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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