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

Phase 3

Recruiting

• Conditions: Psoriatic Arthritis
• Interventions: Drug: TILD sub-cutaneous (SC) injection

• Registration Number: NCT04991116
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

An open label phase 3 study

Detailed 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).

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-05
• Study Start: 2022-06-30
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-24
• Last Update Posted: 2025-10-27
• Primary Completion: 2028-12
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TILD q12 weeks	TILD sub-cutaneous (SC) injection	-

Primary Outcome Measures

Name	Time	Method
Incidence and intensity of Adverse Events (AEs) recorded through the study period	Week 124
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20	Week 124	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: 1. physician's global assessment of disease activity; 2. patient's global assessment of disease activity; 3. patient's assessment of pain; 4. patient's self-assessed disability based on health assessment questionnaire; 5. c-reactive protein
Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50	Week 124	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: 1. physician's global assessment of disease activity; 2. patient's global assessment of disease activity; 3. patient's assessment of pain; 4. patient's self-assessed disability based on health assessment questionnaire; 5. c-reactive protein
Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70	Week 124	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: 1. physician's global assessment of disease activity; 2. patient's global assessment of disease activity; 3. patient's assessment of pain; 4. patient's self-assessed disability based on health assessment questionnaire; 5. c-reactive protein

Trial Locations

Locations (103)

Sunpharma site no 110; 🇺🇸 Encino, California, United States

Sunpharma site no 113; 🇺🇸 Avon Park, Florida, United States

Sunpharma site no 111; 🇺🇸 Leland, North Carolina, United States

Sunpharma site no 109; 🇺🇸 Mesquite, Texas, United States

Sunpharma site no 114; 🇮🇳 Pune, India

Sunpharma site no 112; 🇵🇱 Wroclaw, Poland

Sunpharma site no 50; 🇺🇸 Dothan, Alabama, United States

Sunpharma site no 80; 🇺🇸 Gilbert, Arizona, United States

Sunpharma site no 65; 🇺🇸 Mesa, Arizona, United States

Sunpharma site no 105; 🇺🇸 Phoenix, Arizona, United States

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