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

Last updated: March 4, 2026
Sponsor: Sun Pharmaceutical Industries Limited
Overall Status: Active - Not Recruiting

Phase

3

Condition

Bone Diseases

Psoriasis And Psoriatic Disorders

Joint Injuries

Treatment

TILD sub-cutaneous (SC) injection

Clinical Study ID

NCT04991116
TILD-21-01
  • Ages > 18
  • All Genders

Study Summary

An open label phase 3 study

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects possess the ability to understand the requirements of the study.

  • Subject has provided written informed consent as evidenced by signature on aninformed consent form approved by an institutional review board/EC.

  • Agree to abide by the study restrictions, scheduled treatment, laboratoryassessments, other study procedures and return to the site for the requiredassessments.

  • Subject with PsA who had met all eligibility criteria for the parent study, hadcompleted the parent study treatment period and has not developed any parentprotocol criteria for premature discontinuation of treatment or withdrawal from thestudy.

Exclusion

Exclusion Criteria:

  • Female subjects of childbearing potential who do not agree to abstain fromheterosexual activity or practice a dual method of contraception.

  • Female is pregnant or breastfeeding, or planning to become pregnant or initiatebreastfeeding while enrolled in the study or up to 17 weeks after the last dose ofIMP.

  • Subject has previously been enrolled in this long-term extension study.

  • Any condition that in the opinion of the Investigator represents an obstacle forstudy conduct and/or represents a potential unacceptable risk for the subject.

Study Design

Total Participants: 529
Treatment Group(s): 1
Primary Treatment: TILD sub-cutaneous (SC) injection
Phase: 3
Study Start date:
June 30, 2022
Estimated Completion Date:
April 30, 2029

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).

Connect with a study center

  • Sunpharma site no 59

    Phillip, Australian Capital Territory 2606
    Australia

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    Phillip 2153335, Australian Capital Territory 2177478 2606
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    Maroochydore, Queensland 4558
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    Maroochydore 2207268, Queensland 2152274 4558
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    Hobart, Tasmania 7000
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    Hobart 2163355, Tasmania 2147291 7000
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    Trois-Rivières, G9A 3X2
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    Trois-Rivières 6169141, G9A 3X2
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    Brno, 638 00
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    Brno 3078610, 638 00
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    Prague, 12800
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    Prague, 140 00
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    Prague 3067696, 12800
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    Prague 3067696, 140 00
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    Praha 2, 12800
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    Praha 4, 140 00
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    Zlin, 760 01
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    Zlín, 760 01
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    Zlín 3061370, 760 01
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    Tallinn, 10117
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    Tallinn 588409, 10117
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    Tartu, 50106
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    Tartu, 50708
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    Tartu 588335, 50106
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    Berlin 2950159, 12161
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    Herne, 44649
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    Herne 2905891, 44649
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    Surat, Gujarat 395010
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    Hubli, Karnataka 580021
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    Site Not Available

  • Sunpharma site no 66

    Spokane 5811696, Washington 5815135 99204
    United States

    Site Not Available

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