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Efficacy and Safety Study of SUNPG1622

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: NCT02980705
Recruitment Status : Terminated (Study terminated-Sponsor's decision)
First Posted : December 2, 2016
Results First Posted : February 21, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

Study Description
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Brief Summary:
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.

Condition or disease Intervention/treatment Phase
Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Drug: SUNPG1622 I dose Drug: Placebo dose Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : February 21, 2019
Actual Study Completion Date : September 3, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SUNPG1622 I
SUNPG1622 I dose
 Drug: SUNPG1622 I dose
Injection
Placebo Comparator: Placebo
Placebo dose
 Drug: Placebo dose
Injection


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of SpondyloArthritis International Society 20 Response Rates [ Time Frame: Week 24 ]
    Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).


Secondary Outcome Measures :
  1. Assessment of SpondyloArthritis International Society 20 Response Rates [ Time Frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]
    Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.


Eligibility Criteria
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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:

  • Subject has provided informed written consent
  • Subject is ≥ 18 years of age at time of Screening
  • Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product
  • Subject has a negative test for TB within 4 weeks before initiating IMP

Exclusion Criteria:

  • Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes
  • Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening
  • Radiographic evidence of total ankylosis of the spine
  • Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition
Contacts and Locations
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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): NCT02980705


Locations
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United States, Ohio
SPARC Site 1
Middleburg Heights, Ohio, United States, 44130
Hungary
SPARC site 3
Budapest, Hungary
Poland
SPARC site 3
Elbląg, Poland
Spain
SPARC site 2
A Coruña, Spain
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
  Study Documents (Full-Text)

Documents provided by Sun Pharmaceutical Industries Limited:
Study Protocol  [PDF] June 14, 2017
Statistical Analysis Plan  [PDF] October 1, 2019

More Information
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Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT02980705    
Other Study ID Numbers: CLR_16_22
First Posted: December 2, 2016    Key Record Dates
Results First Posted: February 21, 2021
Last Update Posted: November 1, 2021
Last Verified: October 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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Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Axial Spondyloarthritis
Non-Radiographic Axial Spondyloarthritis
Bone Diseases, Infectious
Infections
 Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases
Spondylarthropathies
Ankylosis