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Active (not recruiting) Phase 3 NCT04991116

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

Phase 3 – large-scale trial before approval
Conditions: Psoriatic Arthritis

Sponsor: Sun Pharmaceutical Industries Limited

trial.available_in: БГ
Overview
An open label phase 3 study
Description
Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).
Who can participate
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.
Locations 14
Australia (1)
Sunpharma site no 59
Phillip , Australian Capital Territory
Canada (1)
Sunpharma site no 95
Trois-Rivières
Czech Republic (1)
Sunpharma site no 36
Brno
Estonia (1)
Sunpharma site no 44
Tallinn
Germany (1)
Sunpharma site no 37
Berlin
India (1)
Sunpharma site no 92
Surat , Gujarat
Italy (1)
Sunpharma site no 90
Verona
Japan (1)
Sunpharma site no 73
Shinjuku-ku , Tokyo
Poland (1)
Sunpharma site no 43
Bialystok
Slovakia (1)
Sunpharma site no 74
Martin
South Korea (1)
Sunpharma site no 70
Seoul
Spain (1)
Sunpharma site no 57
A Coruña
Taiwan (1)
Sunpharma site no 76
Kaohsiung City
United States (1)
Sunpharma site no 50
Dothan , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.06.2022
Completion date
01.04.2029
Registry ID
NCT04991116
Source
anzctr
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