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

Sun Pharmaceutical Industries Limited3 sites in 3 countries180 target enrollmentNovember 6, 2017

ConditionsActive Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis

InterventionsSUNPG1622 I dose Placebo dose

DrugsSUNPG1622 I dose Placebo dose

Overview

Phase: Phase 2
Intervention: SUNPG1622 I dose
Conditions: Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
Sponsor: Sun Pharmaceutical Industries Limited
Enrollment: 180
Locations: 3
Primary Endpoint: Assessment of SpondyloArthritis International Society 20 Response Rates
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 6, 2017

End Date

September 3, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Pharmaceutical Industries Limited

Responsible Party

Sponsor

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

Arms & Interventions

SUNPG1622 I

SUNPG1622 I dose

Intervention: SUNPG1622 I dose

Placebo

Placebo dose

Intervention: Placebo dose

Outcomes

Primary Outcomes

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).