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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 : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Tracking Information
First Submitted Date  ICMJE November 30, 2016
First Posted Date  ICMJE December 2, 2016
Results First Submitted Date  ICMJE September 16, 2020
Results First Posted Date  ICMJE February 21, 2021
Last Update Posted Date February 21, 2021
Actual Study Start Date  ICMJE November 6, 2017
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2020)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
Proportion 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]) [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2021)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
Proportion 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]) [ Time Frame: Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of SUNPG1622
Official Title  ICMJE 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
Brief Summary This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
Intervention  ICMJE
  • Drug: SUNPG1622 I dose
    Injection
  • Drug: Placebo dose
    Injection
Study Arms  ICMJE
  • Experimental: SUNPG1622 I
    SUNPG1622 I dose
    Intervention: Drug: SUNPG1622 I dose
  • Placebo Comparator: Placebo
    Placebo dose
    Intervention: Drug: Placebo dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 30, 2016)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 3, 2019
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02980705
Other Study ID Numbers  ICMJE CLR_16_22
Has Data Monitoring Committee Yes
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  ICMJE Not Provided
Responsible Party Sun Pharma Global FZE
Study Sponsor  ICMJE Sun Pharma Global FZE
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharma Global FZE
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP