Efficacy and Safety Study of SUNPG1622

Phase 2TerminatedNCT02980705

Sun Pharmaceutical Industries Limited180 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis

Interventions

SUNPG1622 I doseDRUG

Injection

Placebo doseDRUG

Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

SPARC Site 1

Middleburg Heights, Ohio, United States

SPARC site 3

Budapest, Hungary

SPARC site 3

Elblag, Poland

SPARC site 2

A Coruña, Spain

Outcomes

Primary Outcomes

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).

Time frame: Week 24

Secondary Outcomes

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.

Time frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Data from ClinicalTrials.gov

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