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

Primary Purpose

Psoriatic Arthritis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TILD sub-cutaneous (SC) injection
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sunpharma site no. 30
  • Sunpharma site no. 17
  • Sunpharma site no. 15
  • Sunpharma site no. 21
  • Sunpharma site no. 02
  • Sunpharma site no. 19
  • Sunpharma site no. 05
  • Sunpharma site no 32
  • SunPharma Site no 22
  • Sunpharma site no. 29
  • Sunpharma site no. 20
  • Sunpharma Site no 26
  • Sunpharma site no. 07
  • Sunpharma site no. 10
  • Sunpharma site no. 14
  • Sunpharma Site no 27
  • Sunpharma site no 33
  • Sunpharma site no. 09
  • Sunpharma site no. 18
  • Sunpharma site no. 11
  • Sunpharma site no. 25
  • Sunpharma site no 31
  • Sunpharma site no. 13
  • Sunpharma site no. 06
  • Sunpharma site no. 08
  • Sunpharma site no. 04
  • Sunpharma Site no 28
  • Sunpharma site no. 03
  • Sunpharma site no. 16
  • Sunpharma site no. 01
  • Sunpharma site no. 12
  • Sunpharma site no. 24
  • SunPharma Site No 23

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TILD q12 weeks

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 29, 2021
Last Updated
September 4, 2023
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04991116
Brief Title
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
Official Title
An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An open label phase 3 study
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TILD q12 weeks
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TILD sub-cutaneous (SC) injection
Intervention Description
1 mL injection of study medication
Primary Outcome Measure Information:
Title
Incidence and intensity of Adverse Events (AEs) recorded through the study period
Time Frame
Week 124
Title
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Description
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: 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
Time Frame
Week 124
Title
Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50
Description
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: 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
Time Frame
Week 124
Title
Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70
Description
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: 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
Time Frame
Week 124

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sunpharma site no. 30
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Sunpharma site no. 17
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Sunpharma site no. 15
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Facility Name
Sunpharma site no. 21
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Sunpharma site no. 02
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Sunpharma site no. 19
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Sunpharma site no. 05
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Sunpharma site no 32
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34751
Country
United States
Facility Name
SunPharma Site no 22
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Sunpharma site no. 29
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Sunpharma site no. 20
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Sunpharma Site no 26
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Sunpharma site no. 07
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Sunpharma site no. 10
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Sunpharma site no. 14
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Sunpharma Site no 27
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Sunpharma site no 33
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Sunpharma site no. 09
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Sunpharma site no. 18
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Sunpharma site no. 11
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Sunpharma site no. 25
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Sunpharma site no 31
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Sunpharma site no. 13
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Sunpharma site no. 06
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Sunpharma site no. 08
City
Houston
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Sunpharma site no. 04
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Sunpharma Site no 28
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Sunpharma site no. 03
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sunpharma site no. 16
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sunpharma site no. 01
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Sunpharma site no. 12
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Sunpharma site no. 24
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
SunPharma Site No 23
City
Córdoba
ZIP/Postal Code
14004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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