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

Last updated: March 3, 2025
Sponsor: Sun Pharmaceutical Industries Limited
Overall Status: Active - Recruiting

Phase

3

Condition

Psoriatic Arthritis

Arthritis And Arthritic Pain

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: 650
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

    Active - Recruiting

  • Sunpharma site no 58

    Maroochydore, Queensland 4558
    Australia

    Active - Recruiting

  • Sunpharma site no. 24

    Hobart, Tasmania 7000
    Australia

    Terminated

  • Sunpharma site no 95

    Trois-Rivières, G9A 3X2
    Canada

    Active - Recruiting

  • Sunpharma site no 36

    Brno, 638 00
    Czechia

    Active - Recruiting

  • Sunpharma site no 67

    Praha 2, 12800
    Czechia

    Active - Recruiting

  • Sunpharma site no 89

    Praha 4, 140 00
    Czechia

    Active - Recruiting

  • Sunpharma site no 82

    Zlin, 760 01
    Czechia

    Active - Recruiting

  • Sunpharma site no 44

    Tallinn, 10117
    Estonia

    Active - Recruiting

  • Sunpharma site no 39

    Tartu, 50106
    Estonia

    Active - Recruiting

  • Sunpharma site no 40

    Tartu, 50708
    Estonia

    Active - Recruiting

  • Sunpharma site no 37

    Berlin, 12161
    Germany

    Active - Recruiting

  • Sunpharma site no 83

    Herne, 44649
    Germany

    Active - Recruiting

  • Sunpharma site no 92

    Surat, Gujrat 395010
    India

    Active - Recruiting

  • Sunpharma site no 101

    Belgaum, Karnataka 590016
    India

    Active - Recruiting

  • Sunpharma site no 91

    Hubli, Karnataka 580021
    India

    Active - Recruiting

  • Sunpharma site no 100

    Bangalore, TN 560010
    India

    Active - Recruiting

  • Sunpharma site no 103

    Chennai, TN 600086
    India

    Site Not Available

  • Sunpharma site no 93

    Chennai, Tamil Nadu 600004
    India

    Active - Recruiting

  • Sunpharma site no 102

    Secunderabad, 500003
    India

    Site Not Available

  • Sunpharma site no 94

    Sevilla, 41014
    India

    Active - Recruiting

  • Sunpharma site no 90

    Verona, 37134
    Italy

    Active - Recruiting

  • Sunpharma site no 73

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Sunpharma site no 45

    Fukuoka, 802-8561
    Japan

    Active - Recruiting

  • Sunpharma site no 84

    Itabashi-ku, 173-8606
    Japan

    Active - Recruiting

  • Sunpharma site no 46

    Kumamoto-shi, 860-8556
    Japan

    Active - Recruiting

  • Sunpharma site no 72

    Mitaka, 181-8611
    Japan

    Active - Recruiting

  • Sunpharma site no 79

    Miyazaki, 889-1692
    Japan

    Active - Recruiting

  • Sunpharma site no 78

    Nagoya, 467-8602
    Japan

    Site Not Available

  • Sunpharma site no 63

    Sendai-shi, 980-8574
    Japan

    Active - Recruiting

  • Sunpharma site no 64

    Sendai-shi, 545-8586
    Japan

    Active - Recruiting

  • Sunpharma site no 87

    Tsu,
    Japan

    Active - Recruiting

  • Sunpharma site no 70

    Seoul, 3080
    Korea, Republic of

    Active - Recruiting

  • Sunpharma site no 98

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • Sunpharma site no 43

    Bialystok, 15-351
    Poland

    Active - Recruiting

  • Sunpharma site no 69

    Bialystok, 15-879
    Poland

    Active - Recruiting

  • Sunpharma site no 56

    Krakow, 30-033
    Poland

    Active - Recruiting

  • Sunpharma site no 81

    Lublin, 20-607
    Poland

    Active - Recruiting

  • Sunpharma site no 55

    Nadarzyn, 05-830
    Poland

    Active - Recruiting

  • Sunpharma site no 68

    Poznan, 61-113
    Poland

    Active - Recruiting

  • Sunpharma site no 85

    Poznan, 60-529
    Poland

    Site Not Available

  • Sunpharma site no 60

    Torun, 87-100
    Poland

    Active - Recruiting

  • Sunpharma site no 61

    Warszawa, 02-118
    Poland

    Active - Recruiting

  • Sunpharma site no 74

    Martin, 036 01
    Slovakia

    Active - Recruiting

  • Sunpharma site no 42

    Nové Mesto Nad Váhom, 915 01
    Slovakia

    Active - Recruiting

  • Sunpharma site no 41

    Rimavska Sobota, 97901
    Slovakia

    Site Not Available

  • Sunpharma site no 38

    Cordoba, 14004
    Spain

    Active - Recruiting

  • SunPharma Site No 23

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Sunpharma site no 57

    La Coruña, 15006
    Spain

    Active - Recruiting

  • Sunpharma site no 86

    Malaga, 29009
    Spain

    Site Not Available

  • Sunpharma site no 88

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Sunpharma site no 62

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Sunpharma site no 97

    Valencia, 46010
    Spain

    Site Not Available

  • Sunpharma site no 76

    Kaohsiung, 833
    Taiwan

    Active - Recruiting

  • Sunpharma site no 54

    Taichung, 402
    Taiwan

    Active - Recruiting

  • Sunpharma site no 99

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Sunpharma site no 75

    Tainan, 710
    Taiwan

    Active - Recruiting

  • Sunpharma site no 77

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Sunpharma site no 50

    Dothan, Alabama 36305
    United States

    Active - Recruiting

  • Sunpharma site no 80

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • Sunpharma site no 65

    Mesa, Arizona 85210
    United States

    Active - Recruiting

  • Sunpharma site no. 30

    Covina, California 91722
    United States

    Active - Recruiting

  • Sunpharma site no. 17

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Sunpharma site no. 15

    Thousand Oaks, California 91320
    United States

    Active - Recruiting

  • Sunpharma site no. 21

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Sunpharma site no. 02

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Sunpharma site no 71

    Kissimmee, Florida 34744
    United States

    Active - Recruiting

  • Sunpharma site no. 19

    Miami, Florida 33135
    United States

    Site Not Available

  • Sunpharma site no. 05

    New Port Richey, Florida 34652
    United States

    Active - Recruiting

  • Sunpharma site no 32

    Ocoee, Florida 34751
    United States

    Active - Recruiting

  • SunPharma Site no 22

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Sunpharma site no. 29

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Sunpharma site no 52

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Sunpharma site no 51

    Orland Park, Illinois 60467
    United States

    Active - Recruiting

  • Sunpharma site no 49

    Schaumburg, Illinois 60195
    United States

    Site Not Available

  • Sunpharma site no 47

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Sunpharma site no. 20

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Sunpharma Site no 26

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Sunpharma site no. 07

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Sunpharma site no. 10

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Sunpharma site no 104

    Saint Louis, Missouri 63119
    United States

    Active - Recruiting

  • Sunpharma site no. 14

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Sunpharma site no 48

    Kalispell, Montana 59901
    United States

    Active - Recruiting

  • Sunpharma Site no 27

    Lincoln, Nebraska 68516
    United States

    Active - Recruiting

  • Sunpharma site no 33

    Voorhees, New Jersey 08043
    United States

    Active - Recruiting

  • Sunpharma site no. 09

    Rochester, New York 14623
    United States

    Site Not Available

  • Sunpharma site no 34

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Sunpharma site no 53

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Sunpharma site no 35

    Minot, North Dakota 58701
    United States

    Active - Recruiting

  • Sunpharma site no. 18

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Sunpharma site no. 11

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Sunpharma site no. 25

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Sunpharma site no 31

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Sunpharma site no. 08

    Baytown, Texas 77521
    United States

    Terminated

  • Sunpharma site no. 13

    Baytown, Texas 77521
    United States

    Active - Recruiting

  • Sunpharma site no. 06

    Houston, Texas 77004
    United States

    Site Not Available

  • Sunpharma site no. 08

    Houston, Texas 77084
    United States

    Site Not Available

  • Sunpharma site no. 04

    League City, Texas 77573
    United States

    Site Not Available

  • Sunpharma Site no 28

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • Sunpharma site no. 03

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Sunpharma site no. 16

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Sunpharma site no. 01

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Sunpharma site no 96

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Sunpharma site no 66

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Sunpharma site no. 12

    Spokane, Washington 99204
    United States

    Site Not Available

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