Efficacy and Safety Study of SUNPG1622
Primary Purpose
Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SUNPG1622 I dose
Placebo dose
Sponsored by
About this trial
This is an interventional treatment trial for Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
Eligibility 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
Sites / Locations
- SPARC Site 1
- SPARC site 3
- SPARC site 3
- SPARC site 2
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SUNPG1622 I
Placebo
Arm Description
SUNPG1622 I dose
Placebo dose
Outcomes
Primary Outcome Measures
Assessment of SpondyloArthritis International Society 20 Response Rates
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
Assessment of SpondyloArthritis International Society 20 Response Rates
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.
Full Information
NCT ID
NCT02980705
First Posted
November 30, 2016
Last Updated
October 29, 2021
Sponsor
Sun Pharmaceutical Industries Limited
1. Study Identification
Unique Protocol Identification Number
NCT02980705
Brief Title
Efficacy and Safety Study of SUNPG1622
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Study terminated-Sponsor's decision
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
February 21, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)
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
Yes
5. Study Description
Brief Summary
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SUNPG1622 I
Arm Type
Experimental
Arm Description
SUNPG1622 I dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dose
Intervention Type
Drug
Intervention Name(s)
SUNPG1622 I dose
Intervention Description
Injection
Intervention Type
Drug
Intervention Name(s)
Placebo dose
Intervention Description
Injection
Primary Outcome Measure Information:
Title
Assessment of SpondyloArthritis International Society 20 Response Rates
Description
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).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Assessment of SpondyloArthritis International Society 20 Response Rates
Description
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.
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
SPARC Site 1
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
SPARC site 3
City
Budapest
Country
Hungary
Facility Name
SPARC site 3
City
Elbląg
Country
Poland
Facility Name
SPARC site 2
City
A Coruña
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of SUNPG1622
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