Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
About the study
An open label phase 3 study
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Psoriatic Arthritis
Age (in years)
18+
Phase
Phase 3
Participants needed
650
Est. Completion Date
Jan 31, 2026
Treatment type
Interventional
Sponsor
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov identifier
NCT04991116
Study number
TILD-21-01
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