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

Psoriatic Arthritis Clinical Trial

Official title:

An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991116
• Other study ID #: TILD-21-01
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2022
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: Sun Pharmaceutical Industries Limited
• Contact: Head, Clinical Developement
• Phone: 9122 66455645
• Email: Clinical.Trial[@]sunpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: January 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• TILD sub-cutaneous (SC) injection
1 mL injection of study medication

Locations

Country	Name	City	State
Australia	Sunpharma site no. 24	Hobart	Tasmania
Australia	Sunpharma site no 58	Maroochydore	Queensland
Australia	Sunpharma site no 59	Phillip	Australian Capital Territory
Czechia	Sunpharma site no 36	Brno
Czechia	Sunpharma site no 67	Praha 2
Czechia	Sunpharma site no 89	Praha 4
Czechia	Sunpharma site no 82	Zlin
Estonia	Sunpharma site no 44	Tallinn
Estonia	Sunpharma site no 39	Tartu
Estonia	Sunpharma site no 40	Tartu
Germany	Sunpharma site no 37	Berlin
Germany	Sunpharma site no 83	Herne
Italy	Sunpharma site no 90	Verona
Japan	Sunpharma site no 45	Fukuoka
Japan	Sunpharma site no 84	Itabashi-ku
Japan	Sunpharma site no 46	Kumamoto-shi
Japan	Sunpharma site no 72	Mitaka
Japan	Sunpharma site no 79	Miyazaki
Japan	Sunpharma site no 78	Nagoya
Japan	Sunpharma site no 63	Sendai-shi
Japan	Sunpharma site no 64	Sendai-shi
Japan	Sunpharma site no 73	Shinjuku-ku	Tokyo
Japan	Sunpharma site no 87	Tsu
Korea, Republic of	Sunpharma site no 70	Seoul
Poland	Sunpharma site no 43	Bialystok
Poland	Sunpharma site no 69	Bialystok
Poland	Sunpharma site no 56	Krakow
Poland	Sunpharma site no 81	Lublin
Poland	Sunpharma site no 55	Nadarzyn
Poland	Sunpharma site no 68	Poznan
Poland	Sunpharma site no 85	Poznan
Poland	Sunpharma site no 60	Torun
Poland	Sunpharma site no 61	Warszawa
Slovakia	Sunpharma site no 74	Martin
Slovakia	Sunpharma site no 42	Nové Mesto Nad Váhom
Slovakia	Sunpharma site no 41	Rimavska Sobota
Spain	Sunpharma site no 38	Cordoba
Spain	SunPharma Site No 23	Córdoba
Spain	Sunpharma site no 57	La Coruña
Spain	Sunpharma site no 86	Malaga
Spain	Sunpharma site no 88	Santiago De Compostela
Spain	Sunpharma site no 62	Sevilla
Taiwan	Sunpharma site no 76	Kaohsiung
Taiwan	Sunpharma site no 54	Taichung
Taiwan	Sunpharma site no 75	Tainan
Taiwan	Sunpharma site no 77	Taipei
United States	Sunpharma site no. 08	Baytown	Texas
United States	Sunpharma site no. 13	Baytown	Texas
United States	Sunpharma site no 34	Charlotte	North Carolina
United States	Sunpharma site no. 21	Clearwater	Florida
United States	Sunpharma site no. 30	Covina	California
United States	Sunpharma site no 50	Dothan	Alabama
United States	Sunpharma site no. 17	Fountain Valley	California
United States	Sunpharma site no 52	Gainesville	Georgia
United States	Sunpharma site no 80	Gilbert	Arizona
United States	Sunpharma site no 31	Greenville	South Carolina
United States	Sunpharma site no. 02	Hialeah	Florida
United States	Sunpharma site no 48	Kalispell	Montana
United States	Sunpharma site no 71	Kissimmee	Florida
United States	Sunpharma Site no 27	Lincoln	Nebraska
United States	Sunpharma Site no 28	Lubbock	Texas
United States	Sunpharma site no 65	Mesa	Arizona
United States	Sunpharma site no. 11	Middleburg Heights	Ohio
United States	Sunpharma site no 35	Minot	North Dakota
United States	Sunpharma site no. 05	New Port Richey	Florida
United States	Sunpharma site no 32	Ocoee	Florida
United States	Sunpharma site no 51	Orland Park	Illinois
United States	Sunpharma site no. 03	San Antonio	Texas
United States	Sunpharma site no. 16	San Antonio	Texas
United States	Sunpharma site no 49	Schaumburg	Illinois
United States	Sunpharma site no 47	Skokie	Illinois
United States	Sunpharma site no 66	Spokane	Washington
United States	Sunpharma site no. 14	Springfield	Missouri
United States	SunPharma Site no 22	Tamarac	Florida
United States	Sunpharma site no. 15	Thousand Oaks	California
United States	Sunpharma site no. 01	Tomball	Texas
United States	Sunpharma site no 33	Voorhees	New Jersey
United States	Sunpharma site no. 20	Wichita	Kansas
United States	Sunpharma site no 53	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  Estonia,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Slovakia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and intensity of Adverse Events (AEs) recorded through the study period		Week 124
Primary	Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20	ACR20 response is an aggregate of: 1. at least 20% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: physician's global assessment of disease activity; patient's global assessment of disease activity; patient's assessment of pain; patient's self-assessed disability based on health assessment questionnaire; c-reactive protein	Week 124
Primary	Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50	ACR50 response is an aggregate of: 1. at least 50% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: physician's global assessment of disease activity; patient's global assessment of disease activity; patient's assessment of pain; patient's self-assessed disability based on health assessment questionnaire; c-reactive protein	Week 124
Primary	Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70	ACR70 response is an aggregate of: 1. at least 70% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: physician's global assessment of disease activity; patient's global assessment of disease activity; patient's assessment of pain; patient's self-assessed disability based on health assessment questionnaire; c-reactive protein	Week 124