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

March 4, 2026 updated by: Sun Pharmaceutical Industries Limited

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

An open label phase 3 study

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

529

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Sunpharma site no 59
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Sunpharma site no 58
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Sunpharma site no. 24
  • Canada
      • Trois-Rivières, Canada, G9A 3X2
        • Sunpharma site no 95
  • Czechia
      • Brno, Czechia, 638 00
        • Sunpharma site no 36
      • Prague, Czechia, 12800
        • Sunpharma site no 67
      • Prague, Czechia, 140 00
        • Sunpharma site no 89
      • Zlín, Czechia, 760 01
        • Sunpharma site no 82
  • Estonia
      • Tallinn, Estonia, 10117
        • Sunpharma site no 44
      • Tartu, Estonia, 50106
        • Sunpharma site no 39
      • Tartu, Estonia, 50708
        • Sunpharma site no 40
  • Germany
      • Berlin, Germany, 12161
        • Sunpharma site no 37
      • Herne, Germany, 44649
        • Sunpharma site no 83
  • India
      • Pune, India, 411007
        • Sunpharma site no 114
      • Secunderabad, India, 500003
        • Sunpharma site no 102
      • Sevilla, India, 41014
        • Sunpharma site no 94
    • Gujarat
      • Surat, Gujarat, India, 395010
        • Sunpharma site no 92
    • Karnataka
      • Belagavi, Karnataka, India, 590016
        • Sunpharma site no 101
      • Hubli, Karnataka, India, 580021
        • Sunpharma site no 91
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Sunpharma site no 108
    • Tamil Nadu
      • Bangalore, Tamil Nadu, India, 560010
        • Sunpharma site no 100
      • Chennai, Tamil Nadu, India, 600004
        • Sunpharma site no 93
      • Chennai, Tamil Nadu, India, 600086
        • Sunpharma site no 103
  • Italy
      • Verona, Italy, 37134
        • Sunpharma site no 90
  • Japan
      • Fukuoka, Japan, 802-8561
        • Sunpharma site no 45
      • Itabashi-ku, Japan, 173-8606
        • Sunpharma site no 84
      • Kumamoto, Japan, 860-8556
        • Sunpharma site no 46
      • Mitaka, Japan, 181-8611
        • Sunpharma site no 72
      • Miyazaki, Japan, 889-1692
        • Sunpharma site no 79
      • Sendai, Japan, 545-8586
        • Sunpharma site no 64
      • Sendai, Japan, 980-8574
        • Sunpharma site no 63
      • Tsu, Japan
        • Sunpharma site no 87
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Sunpharma site no 73
  • Poland
      • Bialystok, Poland, 15-351
        • Sunpharma site no 43
      • Bialystok, Poland, 15-879
        • Sunpharma site no 69
      • Krakow, Poland, 30-033
        • Sunpharma site no 56
      • Lublin, Poland, 20-607
        • Sunpharma site no 81
      • Nadarzyn, Poland, 05-830
        • Sunpharma site no 55
      • Olsztyn, Poland
        • Sunpharma site no 106
      • Poznan, Poland, 61-113
        • Sunpharma site no 68
      • Torun, Poland, 87-100
        • Sunpharma site no 60
      • Warsaw, Poland, 02-118
        • Sunpharma site no 61
      • Wroclaw, Poland, 52-416
        • Sunpharma site no 112
  • Slovakia
      • Martin, Slovakia, 036 01
        • Sunpharma site no 74
      • Nové Mesto nad Váhom, Slovakia, 915 01
        • Sunpharma site no 42
  • South Korea
      • Seoul, South Korea, 3080
        • Sunpharma site no 70
  • Spain
      • A Coruña, Spain, 15006
        • Sunpharma site no 57
      • Córdoba, Spain, 14004
        • SunPharma Site No 23
      • Córdoba, Spain, 14004
        • Sunpharma site no 38
      • Málaga, Spain, 29009
        • Sunpharma site no 86
      • Santiago de Compostela, Spain, 15706
        • Sunpharma site no 88
      • Seville, Spain, 41013
        • Sunpharma site no 62
      • Valencia, Spain, 46010
        • Sunpharma site no 97
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Sunpharma site no 76
      • Taichung, Taiwan, 402
        • Sunpharma site no 54
      • Taichung, Taiwan, 40705
        • Sunpharma site no 99
      • Tainan, Taiwan, 710
        • Sunpharma site no 75
      • Taipei, Taiwan, 112
        • Sunpharma site no 77
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Sunpharma site no 50
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Sunpharma site no 80
      • Mesa, Arizona, United States, 85210
        • Sunpharma site no 65
      • Phoenix, Arizona, United States, 85032
        • Sunpharma site no 105
    • California
      • Covina, California, United States, 91722
        • Sunpharma site no. 30
      • Encino, California, United States, 91436
        • Sunpharma site no 110
      • Fountain Valley, California, United States, 92708
        • Sunpharma site no. 17
      • Thousand Oaks, California, United States, 91320
        • Sunpharma site no. 15
    • Florida
      • Avon Park, Florida, United States, 33825
        • Sunpharma site no 113
      • Clearwater, Florida, United States, 33765
        • Sunpharma site no. 21
      • Hialeah, Florida, United States, 33016
        • Sunpharma site no. 02
      • Kissimmee, Florida, United States, 34744
        • Sunpharma site no 71
      • Margate, Florida, United States, 33063
        • Sunpharma site no 107
      • New Port Richey, Florida, United States, 34652
        • Sunpharma site no. 05
      • Ocoee, Florida, United States, 34751
        • Sunpharma site no 32
      • Tamarac, Florida, United States, 33321
        • SunPharma Site no 22
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Sunpharma site no 52
    • Illinois
      • Orland Park, Illinois, United States, 60467
        • Sunpharma site no 51
      • Schaumburg, Illinois, United States, 60195
        • Sunpharma site no 49
      • Skokie, Illinois, United States, 60076
        • Sunpharma site no 47
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Sunpharma site no. 20
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Sunpharma site no. 14
      • St Louis, Missouri, United States, 63119
        • Sunpharma site no 104
    • Montana
      • Kalispell, Montana, United States, 59901
        • Sunpharma site no 48
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Sunpharma Site no 27
    • New Jersey
      • Voorhees Township, New Jersey, United States, 08043
        • Sunpharma site no 33
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Sunpharma site no 34
      • Leland, North Carolina, United States, 28451
        • Sunpharma site no 111
      • Wilmington, North Carolina, United States, 28401
        • Sunpharma site no 53
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Sunpharma site no 35
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Sunpharma site no. 11
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Sunpharma site no 31
    • Texas
      • Baytown, Texas, United States, 77521
        • Sunpharma site no. 13
      • Baytown, Texas, United States, 77521
        • Sunpharma site no. 08
      • Lubbock, Texas, United States, 79410
        • Sunpharma Site no 28
      • Mesquite, Texas, United States, 75150
        • Sunpharma site no 109
      • San Antonio, Texas, United States, 78229
        • Sunpharma site no. 03
      • San Antonio, Texas, United States, 78229
        • Sunpharma site no. 16
      • Tomball, Texas, United States, 77375
        • Sunpharma site no. 01
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Sunpharma site no 96
    • Washington
      • Spokane, Washington, United States, 99204
        • Sunpharma site no 66

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and intensity of Adverse Events (AEs) recorded through the study period
Time Frame: Week 124
Week 124
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Time Frame: 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
Week 124
Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50
Time Frame: 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
Week 124
Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70
Time Frame: 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
Week 124

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TILD-21-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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