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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified February 2026 by Sun Pharmaceutical Industries Limited
Sponsor
Sun Pharmaceutical Industries Limited
Information Provided by (Responsible Party)
Sun Pharmaceutical Industries Limited
Clinicaltrials.gov Identifier
NCT04991116
Other Study ID Numbers:
TILD-21-01
First Submitted
July 28, 2021
First Posted
August 4, 2021
Last Update Posted
March 4, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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).

Condition or DiseaseIntervention/Treatment
Psoriatic Arthritis
Drug: TILD sub-cutaneous (SC) injection

Study Design

Study TypeInterventional
Actual Enrollment529 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.
Study Start DateJune 29, 2022
Actual Primary Completion Date2yrs 6mos from now
Actual Study Completion Date2yrs 10mos from now

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures
  1. Incidence and intensity of Adverse Events (AEs) recorded through the study period
  2. 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: 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
  3. 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: 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
  4. 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: 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

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsSun Pharmaceutical Industries Limited
Locations
Sunpharma site no 50 | Dothan Alabama, United States, 36305Sunpharma site no 80 | Gilbert Arizona, United States, 85297Sunpharma site no 65 | Mesa Arizona, United States, 85210Sunpharma site no 105 | Phoenix Arizona, United States, 85032Sunpharma site no. 30 | Covina California, United States, 91722Sunpharma site no 110 | Encino California, United States, 91436Sunpharma site no. 17 | Fountain Valley California, United States, 92708Sunpharma site no. 15 | Thousand Oaks California, United States, 91320Sunpharma site no 113 | Avon Park Florida, United States, 33825Sunpharma site no. 21 | Clearwater Florida, United States, 33765Sunpharma site no. 02 | Hialeah Florida, United States, 33016Sunpharma site no 71 | Kissimmee Florida, United States, 34744Sunpharma site no 107 | Margate Florida, United States, 33063Sunpharma site no. 05 | New Port Richey Florida, United States, 34652Sunpharma site no 32 | Ocoee Florida, United States, 34751SunPharma Site no 22 | Tamarac Florida, United States, 33321Sunpharma site no 52 | Gainesville Georgia, United States, 30501Sunpharma site no 51 | Orland Park Illinois, United States, 60467Sunpharma site no 49 | Schaumburg Illinois, United States, 60195Sunpharma site no 47 | Skokie Illinois, United States, 60076Sunpharma site no. 20 | Wichita Kansas, United States, 67207Sunpharma site no. 14 | Springfield Missouri, United States, 65807Sunpharma site no 104 | St Louis Missouri, United States, 63119Sunpharma site no 48 | Kalispell Montana, United States, 59901Sunpharma Site no 27 | Lincoln Nebraska, United States, 68516Sunpharma site no 33 | Voorhees Township New Jersey, United States, 08043Sunpharma site no 34 | Charlotte North Carolina, United States, 28204Sunpharma site no 111 | Leland North Carolina, United States, 28451Sunpharma site no 53 | Wilmington North Carolina, United States, 28401Sunpharma site no 35 | Minot North Dakota, United States, 58701Sunpharma site no. 11 | Middleburg Heights Ohio, United States, 44130Sunpharma site no 31 | Greenville South Carolina, United States, 29601Sunpharma site no. 08 | Baytown Texas, United States, 77521Sunpharma site no. 13 | Baytown Texas, United States, 77521Sunpharma Site no 28 | Lubbock Texas, United States, 79410Sunpharma site no 109 | Mesquite Texas, United States, 75150Sunpharma site no. 03 | San Antonio Texas, United States, 78229Sunpharma site no. 16 | San Antonio Texas, United States, 78229Sunpharma site no. 01 | Tomball Texas, United States, 77375Sunpharma site no 96 | Salt Lake City Utah, United States, 84132Sunpharma site no 66 | Spokane Washington, United States, 99204Sunpharma site no 59 | Phillip Australian Capital Territory, Australia, 2606Sunpharma site no 58 | Maroochydore Queensland, Australia, 4558Sunpharma site no. 24 | Hobart Tasmania, Australia, 7000Sunpharma site no 95 | Trois-Rivières , Canada, G9A 3X2Sunpharma site no 36 | Brno , Czechia, 638 00Sunpharma site no 67 | Prague , Czechia, 12800Sunpharma site no 89 | Prague , Czechia, 140 00Sunpharma site no 82 | Zlín , Czechia, 760 01Sunpharma site no 44 | Tallinn , Estonia, 10117Sunpharma site no 39 | Tartu , Estonia, 50106Sunpharma site no 40 | Tartu , Estonia, 50708Sunpharma site no 37 | Berlin , Germany, 12161Sunpharma site no 83 | Herne , Germany, 44649Sunpharma site no 92 | Surat Gujarat, India, 395010Sunpharma site no 101 | Belagavi Karnataka, India, 590016Sunpharma site no 91 | Hubli Karnataka, India, 580021Sunpharma site no 108 | Pune Maharashtra, India, 411004Sunpharma site no 100 | Bangalore Tamil Nadu, India, 560010Sunpharma site no 93 | Chennai Tamil Nadu, India, 600004Sunpharma site no 103 | Chennai Tamil Nadu, India, 600086Sunpharma site no 114 | Pune , India, 411007Sunpharma site no 102 | Secunderabad , India, 500003Sunpharma site no 94 | Sevilla , India, 41014Sunpharma site no 90 | Verona , Italy, 37134Sunpharma site no 73 | Shinjuku-ku Tokyo, Japan, 160-0023Sunpharma site no 45 | Fukuoka , Japan, 802-8561Sunpharma site no 84 | Itabashi-ku , Japan, 173-8606Sunpharma site no 46 | Kumamoto , Japan, 860-8556Sunpharma site no 72 | Mitaka , Japan, 181-8611Sunpharma site no 79 | Miyazaki , Japan, 889-1692Sunpharma site no 64 | Sendai , Japan, 545-8586Sunpharma site no 63 | Sendai , Japan, 980-8574Sunpharma site no 87 | Tsu , Japan, Sunpharma site no 43 | Bialystok , Poland, 15-351Sunpharma site no 69 | Bialystok , Poland, 15-879Sunpharma site no 56 | Krakow , Poland, 30-033Sunpharma site no 81 | Lublin , Poland, 20-607Sunpharma site no 55 | Nadarzyn , Poland, 05-830Sunpharma site no 106 | Olsztyn , Poland, Sunpharma site no 68 | Poznan , Poland, 61-113Sunpharma site no 60 | Torun , Poland, 87-100Sunpharma site no 61 | Warsaw , Poland, 02-118Sunpharma site no 112 | Wroclaw , Poland, 52-416Sunpharma site no 74 | Martin , Slovakia, 036 01Sunpharma site no 42 | Nové Mesto nad Váhom , Slovakia, 915 01Sunpharma site no 70 | Seoul , South Korea, 3080Sunpharma site no 57 | A Coruña , Spain, 15006SunPharma Site No 23 | Córdoba , Spain, 14004Sunpharma site no 38 | Córdoba , Spain, 14004Sunpharma site no 86 | Málaga , Spain, 29009Sunpharma site no 88 | Santiago de Compostela , Spain, 15706Sunpharma site no 62 | Seville , Spain, 41013Sunpharma site no 97 | Valencia , Spain, 46010Sunpharma site no 76 | Kaohsiung City , Taiwan, 833Sunpharma site no 54 | Taichung , Taiwan, 402Sunpharma site no 99 | Taichung , Taiwan, 40705Sunpharma site no 75 | Tainan , Taiwan, 710Sunpharma site no 77 | Taipei , Taiwan, 112