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

Study Overview
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Brief Summary
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An open label phase 3 study

Detailed Description
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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).

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

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: TILD sub-cutaneous (SC) injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TILD q12 weeks<br> | Drug: TILD sub-cutaneous (SC) injection<br>* 1 mL injection of study medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| 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 | 
| 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 |