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Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
RECRUITINGPhase 3Sponsored by Sun Pharmaceutical Industries Limited
Actively Recruiting
PhasePhase 3
SponsorSun Pharmaceutical Industries Limited
Started2022-06-30
Est. completion2028-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations41 sites
View on ClinicalTrials.gov →
NCT04991116
Summary
An open label phase 3 study
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
ArthritisPsoriatic Arthritis
Locations41 sites
Sunpharma site no 50
Dothan, Alabama, 36305
Sunpharma site no 80
Gilbert, Arizona, 85297
Sunpharma site no 65
Mesa, Arizona, 85210
Sunpharma site no 105
Phoenix, Arizona, 85032
Sunpharma site no. 30
Covina, California, 91722
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Actively Recruiting
PhasePhase 3
SponsorSun Pharmaceutical Industries Limited
Started2022-06-30
Est. completion2028-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations41 sites
View on ClinicalTrials.gov →
NCT04991116