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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552276
Recruitment Status : Active, not recruiting
First Posted : June 11, 2018
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: SUNPG18_07 I Drug: SUNPG18_07 II Drug: SUNPG18_07 III Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
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
Official Title: A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SUNPG18_07 q4 weeks, high dose Drug: SUNPG18_07 I
injection

Drug: SUNPG18_07 III
injection

Experimental: SUNPG18_07 q12 weeks, high dose Drug: SUNPG18_07 II
injection

Drug: SUNPG18_07 III
injection

Experimental: SUNPG18_07 q12 weeks, low dose Drug: SUNPG18_07 III
injection




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552276


Locations
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Sponsors and Collaborators
Sun Pharma Global FZE
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Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT03552276    
Other Study ID Numbers: CLR_18_07
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases