Clinical Trial: Efficacy and Safety Study of SUNPG1622

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Spondyloarth

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

Detailed Summary:
Sponsor: Sun Pharma Global FZE

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Sun Pharma Global FZE

Dates:
Date Received: November 30, 2016
Date Started: June 30, 2017
Date Completion: September 2019
Last Updated: May 11, 2017
Last Verified: May 2017