A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis

Idera Pharmaceuticals, Inc.20 sites in 3 countries30 target enrollmentNovember 2015

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Dermatomyositis
Sponsor: Idera Pharmaceuticals, Inc.
Enrollment: 30
Locations: 20
Primary Endpoint: To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
Status: Completed
Last Updated: 6 years ago

The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.

This study will evaluate the safety and efficacy of IMO-8400 in adults with active dermatomyositis (DM).

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

June 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Has definite or probable DM based on the criteria of Bohan and Peter
•Has a Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)-Activity score ≥15
•Patients with muscle weakness are eligible; however having muscle weakness is not mandatory.
•Study participants must have a diagnostic evaluation for cancer if the diagnosis of DM was within 2 years prior to the Screening Visit

•Has ongoing severe dysphagia (e.g., requires a feeding tube) for the 3 months prior to Screening
•Has known hypersensitivity to any oligodeoxynucleotide
•Has a history of drug or alcohol abuse within one year of screening, or evidence of drug abuse by urine drug screening
•Has body weight \>140 kg
•Has a diagnosis of Juvenile DM, IBM, drug-induced toxic myopathy, metabolic myopathy, dystrophy, cancer-associated DM, or connective tissue disease-associated DM (e.g., overlap syndrome)
•Has received one or more of following prohibited treatments within the interval noted prior to Screening (Visit 1):
•Rituximab within 24 weeks (Note: patients who received rituximab are only eligible for inclusion if B-cell counts are confirmed to be within normal limits)
•Intravenous corticosteroids within 12 weeks
•Antimalarials (e.g., hydroxychloroquine) within 36 weeks
•Topical corticosteroids (excluding scalp) within 2 weeks