Efficacy and Safety Study of SUNPG1622

Phase 2

Terminated

• Conditions: Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
• Interventions: Drug: Placebo dose; Drug: SUNPG1622 I dose

• Registration Number: NCT02980705
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-02
• Study Start: 2017-11-06
• Primary Completion: 2019-02-21
• Study Completion: 2019-09-03
• Results First Submitted: 2020-09-16
• Results First Submitted QC: 2021-02-12
• Results First Posted: 2021-02-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo dose	Placebo dose
SUNPG1622 I	SUNPG1622 I dose	SUNPG1622 I dose

Primary Outcome Measures

Name	Time	Method
Assessment of SpondyloArthritis International Society 20 Response Rates	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

Name	Time	Method
Assessment of SpondyloArthritis International Society 20 Response Rates	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.

Trial Locations

Locations (3)

SPARC site 3; 🇵🇱 Elbląg, Poland

SPARC Site 1; 🇺🇸 Middleburg Heights, Ohio, United States

SPARC site 2; 🇪🇸 A Coruña, Spain