Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

• ClinicalTrials.gov Identifier: NCT03552276
• Recruitment Status: Active, not recruiting
• First Posted: June 11, 2018
• Last Update Posted: August 29, 2022
• Sponsor: Sun Pharmaceutical Industries Limited
• Information provided by (Responsible Party): Sun Pharmaceutical Industries Limited

Tracking Information

• First Submitted Date: May 4, 2018
• First Posted Date: June 11, 2018
• Last Update Posted Date: August 29, 2022
• Actual Study Start Date: July 11, 2018
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 6, 2021): Number of Participants with adverse events and its relationship to investigational medicinal product will be assessed by the Investigator (Global Introspection assessment) [ Time Frame: upto week 208 ]

Original Primary Outcome Measures (submitted: June 8, 2018)

Incidence of adverse events [ Time Frame: 4 years ]

Incidence and intensity of adverse events will be assessed

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: June 8, 2018)

Proportion of subjects achieving a 20% reduction from Baseline in American College of Rheumatology response criteria [ Time Frame: 4 years ]

Improvement from Baseline in both tender joints and swollen joints will be assessed.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
• Official Title: A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
• Brief Summary: A long term study to demonstrate the Safety and Efficacy of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab Spondyloarthritis.

Detailed Description

Subjects have rolled over from parent study, i.e., CLR_16_23, into the long-term extension study CLR_18_07.

The study has been open label post 1 year completion.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3

Study Design

Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description:

Subjects will be not be randomized and will enter the long-term extension study with one fixed dose regimen of tildrakizumab, low dose regimen at Week 52 of the parent study.

Study continued to be double blind until wk 52 and there after open label. Subjects continue to assigned treatment from parent study up to week 52 in the Long term extension and there after all subjects began migrating to receive low dose injection Q12 weeks in an open-label fashion for up to an additional 4 years..

Primary Purpose: Treatment

• Condition: Psoriatic Arthritis

Intervention

• Drug: SUNPG18_07 I
  injection
• Drug: SUNPG18_07 II
  injection
• Drug: SUNPG18_07 III
  injection

Study Arms

• Experimental: SUNPG18_07 q4 weeks, high dose
  Interventions:

  • Drug: SUNPG18_07 I
  • Drug: SUNPG18_07 III
• Experimental: SUNPG18_07 q12 weeks, high dose
  Interventions:

  • Drug: SUNPG18_07 II
  • Drug: SUNPG18_07 III
• Experimental: SUNPG18_07 q12 weeks, low dose
  Intervention: Drug: SUNPG18_07 III

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 6, 2021): 286
• Original Estimated Enrollment (submitted: June 8, 2018): 540
• Estimated Study Completion Date: August 30, 2023
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Subjects may be included in the study if they meet all of the following criteria:

1. Subject has provided written informed consent for this long-term extension study.
2. Subjects with PsA who met the inclusion criteria of the parent study and completed the parent study treatment period (e.g., up to Week 48 for the parent Phase 2 study, with return for the EoT assessment at Week 52).
3. No concomitant use of both leflunomide and methotrexate,
4. No history of active tuberculosis (TB) or symptoms of TB.

Exclusion Criteria:

Subjects should be excluded from the study if they meet any of the following criteria:

1. New onset during the parent study of arthritic conditions other than the subject's original condition.
2. Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo-progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 16 weeks following final administration of IMP.
3. Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 16 weeks after the last dose of IMP.
4. Subject has previously been enrolled in this long-term extension study.
5. 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.
6. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject.
7. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study.
8. Subjects with a history of alcohol or drug abuse during the parent study.
9. Subject has a need for use of a live vaccine within 10 weeks of final anticipated dose of IMP for the long-term extension study.
10. Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than tildrakizumab) for PsO and/or PsA
11. Subjects who have been placed in an institution on official or judicial orders.
12. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Hungary, Mexico, Poland, Russian Federation, Spain, Ukraine, United States

Administrative Information

• NCT Number: NCT03552276
• Other Study ID Numbers: CLR_18_07
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sun Pharmaceutical Industries Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Sun Pharmaceutical Industries Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sun Pharmaceutical Industries Limited
• Verification Date: February 2022