Psoriasis Clinical Trial

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

Summary

An open label phase 3 study

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Full 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).

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT04991116

Recruitment Status:

Recruiting

Sponsor:

Sun Pharmaceutical Industries Limited

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There are 75 Locations for this study

See Locations Near You

Sunpharma site no 50
Dothan Alabama, 36305, United States
Sunpharma site no 80
Gilbert Arizona, 85297, United States
Sunpharma site no 65
Mesa Arizona, 85210, United States
Sunpharma site no. 30
Covina California, 91722, United States
Sunpharma site no. 17
Fountain Valley California, 92708, United States
Sunpharma site no. 15
Thousand Oaks California, 91320, United States
Sunpharma site no. 21
Clearwater Florida, 33765, United States
Sunpharma site no. 02
Hialeah Florida, 33016, United States
Sunpharma site no 71
Kissimmee Florida, 34744, United States
Sunpharma site no. 05
New Port Richey Florida, 34652, United States
Sunpharma site no 32
Ocoee Florida, 34751, United States
SunPharma Site no 22
Tamarac Florida, 33321, United States
Sunpharma site no 52
Gainesville Georgia, 30501, United States
Sunpharma site no 51
Orland Park Illinois, 60467, United States
Sunpharma site no 49
Schaumburg Illinois, 60195, United States
Sunpharma site no 47
Skokie Illinois, 60076, United States
Sunpharma site no. 20
Wichita Kansas, 67207, United States
Sunpharma site no. 14
Springfield Missouri, 65807, United States
Sunpharma site no 48
Kalispell Montana, 59901, United States
Sunpharma Site no 27
Lincoln Nebraska, 68516, United States
Sunpharma site no 33
Voorhees New Jersey, 08043, United States
Sunpharma site no 34
Charlotte North Carolina, 28204, United States
Sunpharma site no 53
Wilmington North Carolina, 28401, United States
Sunpharma site no 35
Minot North Dakota, 58701, United States
Sunpharma site no. 11
Middleburg Heights Ohio, 44130, United States
Sunpharma site no 31
Greenville South Carolina, 29601, United States
Sunpharma site no. 08
Baytown Texas, 77521, United States
Sunpharma site no. 13
Baytown Texas, 77521, United States
Sunpharma Site no 28
Lubbock Texas, 79410, United States
Sunpharma site no. 03
San Antonio Texas, 78229, United States
Sunpharma site no. 16
San Antonio Texas, 78229, United States
Sunpharma site no. 01
Tomball Texas, 77375, United States
Sunpharma site no 66
Spokane Washington, 99204, United States
Sunpharma site no 59
Phillip Australian Capital Territory, 2606, Australia
Sunpharma site no 58
Maroochydore Queensland, 4558, Australia
Sunpharma site no. 24
Hobart Tasmania, 7000, Australia
Sunpharma site no 36
Brno , 638 0, Czechia
Sunpharma site no 67
Praha 2 , 12800, Czechia
Sunpharma site no 89
Praha 4 , 140 0, Czechia
Sunpharma site no 82
Zlin , 760 0, Czechia
Sunpharma site no 44
Tallinn , 10117, Estonia
Sunpharma site no 39
Tartu , 50106, Estonia
Sunpharma site no 40
Tartu , 50708, Estonia
Sunpharma site no 37
Berlin , 12161, Germany
Sunpharma site no 83
Herne , 44649, Germany
Sunpharma site no 90
Verona , 37134, Italy
Sunpharma site no 73
Shinjuku-ku Tokyo, 160-0, Japan
Sunpharma site no 45
Fukuoka , 802-8, Japan
Sunpharma site no 84
Itabashi-ku , 173-8, Japan
Sunpharma site no 46
Kumamoto-shi , 860-8, Japan
Sunpharma site no 72
Mitaka , 181-8, Japan
Sunpharma site no 79
Miyazaki , 889-1, Japan
Sunpharma site no 78
Nagoya , 467-8, Japan
Sunpharma site no 64
Sendai-shi , 545-8, Japan
Sunpharma site no 63
Sendai-shi , 980-8, Japan
Sunpharma site no 87
Tsu , , Japan
Sunpharma site no 70
Seoul , 3080, Korea, Republic of
Sunpharma site no 43
Bialystok , 15-35, Poland
Sunpharma site no 69
Bialystok , 15-87, Poland
Sunpharma site no 56
Krakow , 30-03, Poland
Sunpharma site no 81
Lublin , 20-60, Poland
Sunpharma site no 55
Nadarzyn , 05-83, Poland
Sunpharma site no 85
Poznan , 60-52, Poland
Sunpharma site no 68
Poznan , 61-11, Poland
Sunpharma site no 60
Torun , 87-10, Poland
Sunpharma site no 61
Warszawa , 02-11, Poland
Sunpharma site no 74
Martin , 036 0, Slovakia
Sunpharma site no 42
Nové Mesto Nad Váhom , 915 0, Slovakia
Sunpharma site no 41
Rimavska Sobota , 97901, Slovakia
Sunpharma site no 38
Cordoba , 14004, Spain
SunPharma Site No 23
Córdoba , 14004, Spain
Sunpharma site no 57
La Coruña , 15006, Spain
Sunpharma site no 86
Malaga , 29009, Spain
Sunpharma site no 88
Santiago De Compostela , 15706, Spain
Sunpharma site no 62
Sevilla , 41013, Spain
Sunpharma site no 76
Kaohsiung , 833, Taiwan
Sunpharma site no 54
Taichung , 402, Taiwan
Sunpharma site no 75
Tainan , 710, Taiwan
Sunpharma site no 77
Taipei , 112, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT04991116

Recruitment Status:

Recruiting

Sponsor:


Sun Pharmaceutical Industries Limited

How clear is this clinincal trial information?

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