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 51 Locations for this study

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Sunpharma site no 50
Dothan Alabama, 36305, United States
Sunpharma site no. 30
Covina California, 91722, United States
Sunpharma site no. 17
Fountain Valley California, 92708, United States More Info
Vivian T Laquer, M.D
Contact
714-531-2966
[email protected]
Sunpharma site no. 15
Thousand Oaks California, 91320, United States More Info
Navid Ezra, M.D.
Contact
805-222-5803
[email protected]
Sunpharma site no. 21
Clearwater Florida, 33765, United States More Info
Robert Levin, M.D.
Contact
727-734-6631
[email protected]
Sunpharma site no. 02
Hialeah Florida, 33016, 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 More Info
Steven Kimmel, M.D.
Contact
954-545-8400
[email protected]
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 More Info
Shadi H Shahouri, M.D., FACR
Contact
316-689-6683
[email protected]
Sunpharma site no. 14
Springfield Missouri, 65810, United States More Info
David G True, D.O., FACR
Contact
417-883-7889
[email protected]
Sunpharma site no 48
Kalispell Montana, 59901, United States
Sunpharma Site no 27
Lincoln Nebraska, 68516, United States More Info
Melvin Churchill, M.D.
Contact
402-420-3433
[email protected]
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 More Info
Isam A Diab, M.D.
Contact
440-826-0742
[email protected]
Sunpharma site no 31
Greenville South Carolina, 29601, United States More Info
Jeff Lawson, M.D.
Contact
864-527-2307
[email protected]
Sunpharma site no. 13
Baytown Texas, 77521, United States More Info
Sabeen Najam, M.D.
Contact
281-422-7179
[email protected]
Sunpharma site no. 08
Houston Texas, 77084, United States More Info
Amber Khan, M.D.
Contact
832-672-7973
[email protected]
Sunpharma Site no 28
Lubbock Texas, 79410, United States More Info
Jitendra Vasandani, M.D.
Contact
806-993-1040
[email protected]
Sunpharma site no. 03
San Antonio Texas, 78229, United States More Info
Pendleton Wickersham, M.D., P.A.
Contact
210-980-1742
[email protected]
Sunpharma site no. 16
San Antonio Texas, 78229, United States More Info
Pendleton B Wickersham, M.D.
Contact
210-477-2626
[email protected]
Sunpharma site no. 01
Tomball Texas, 77375, 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 More Info
Jane Zochling, Mmed, FRACP
Contact
61-36223-8802
[email protected]
Sunpharma site no 36
Brno , 638 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 45
Fukuoka , 802-8, Japan
Sunpharma site no 46
Kumamoto-shi , 860-8, Japan
Sunpharma site no 63
Sendai-shi , 545-8, Japan
Sunpharma site no 63
Sendai-shi , 980-8, Japan
Sunpharma site no 43
Bialystok , 15-35, Poland
Sunpharma site no 56
Krakow , 30-03, Poland
Sunpharma site no 55
Nadarzyn , 05-83, Poland
Sunpharma site no 60
Torun , 87-10, Poland
Sunpharma site no 61
Warszawa , 02-11, Poland
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 More Info
Alejandro Escudero Contreras, Degree in Med.
Contact
34957010429
[email protected]
Sunpharma site no 57
La Coruña , 15006, Spain
Sunpharma site no 62
Sevilla , 41013, Spain
Sunpharma site no 54
Taichung , 402, 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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