Trial intelligence / Profile preview

Hemay005 in active ankylosing spondylitis

NCT05407246Phase 2

Key facts

Status: Completed
Start: Aug 2022
Primary completion: Aug 2023
Countries: 1
Sponsor: Tianjin Hemay Biotech
Modality: Small Molecules

Drugs: mufemilast
Conditions: ankylosing spondylitis (AS)

Overview

Phase 2, randomised, double-blind trial of mufemilast in ankylosing spondylitis (AS), sponsored by Tianjin Hemay Biotech. Primary endpoint: Assessment of SpondyloArthritis international Society 20 response at week 16. Started Aug 2022; status: completed.

Design

Study design: RandomizedDouble-blind

Who it enrols

Adult patients (18-65) with active ankylosing spondylitis (BASDAI >= 4) who are HLA-B27 positive and have had an inadequate response or intolerance to NSAIDs.

Endpoints

Primary

Assessment of SpondyloArthritis international Society 20 responseweek 16

Secondary

Bath Ankylosing Spondylitis Functional Indexweek 16
Bath Ankylosing Spondylitis Disease Activity Indexweek 16
Assessment of SpondyloArthritis international Society 20 responseweek 12
Assessment of SpondyloArthritis international Society 40 responseweek 16
Ankylosing Spondylitis Quality of Lifeweek 16
Bath Ankylosing Spondylitis Metrology Indexweek 16
high-sensitivity C-reactive proteinweek 16
Maastricht Ankylosing Spondylitis Enthesitis Scoreweek 16

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