Clinical Trial: Trial of IMO-8400 in Adult Patients With Dermatomyositis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis
Brief Summary: The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.
Detailed Summary: This study will evaluate the safety and efficacy of IMO-8400 in adults with active dermatomyositis (DM).
Sponsor: Idera Pharmaceuticals, Inc.
Current Primary Outcome:
- Incidence and frequency of adverse events, injection site reaction, physical exam and laboratory exam findings with escalating dose levels of IMO-8400 [ Time Frame: 28 weeks (24 weeks treatment + 4 weeks follow up) ]
- Change from baseline in CDASI Activity score [ Time Frame: 28 weeks (24 weeks treatment + 4 weeks follow up) ]
Original Primary Outcome:
- Incidence of adverse events, injection site reaction, physical exam and laboratory exam findings with escalating dose levels of IMO-8400 [ Time Frame: 28 weeks (24 weeks treatment + 4 weeks follow up) ]
- Frequency of adverse events, injection site reaction, physical exam and laboratory exam findings with escalating dose levels of IMO-8400 [ Time Frame: 28 weeks (24 weeks treatment + 4 weeks follow up) ]
- Change from baseline in CDASI Activity score [ Time Frame: 28 weeks (24 weeks treatment + 4 weeks follow up) ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Idera Pharmaceuticals, Inc.
Dates:
Date Received: November 18, 2015
Date Started: November 2015
Date Completion: August 2017
Last Updated: March 30, 2017
Last Verified: March 2017
