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Active, Not Recruiting

NCT Number: NCT04991116

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

An open label phase 3 study

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sunpharma site no 59, Phillip, Australian Capital Territory, Australia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TILD sub-cutaneous (SC) injection

Drug

1 mL injection of study medication

Primary outcomes

  1. Incidence and intensity of Adverse Events (AEs) recorded through the study period

    Time frame: Week 124

  2. Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20

    Time frame: Week 124

    ACR20 response is an aggregate of:

    • 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

  3. Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50

    Time frame: Week 124

    ACR50 response is an aggregate of:

    • 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

  4. Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70

    Time frame: Week 124

    ACR70 response is an aggregate of:

    • 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

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Aug 5, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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