Trial of IMO-8400 in Adult Patients With Dermatomyositis

Phase 2

Completed

• Conditions: Dermatomyositis
• Interventions: Drug: IMO-8400 Dose Group 1; Drug: Placebo; Drug: IMO-8400 Dose Group 2

• Registration Number: NCT02612857
• Lead Sponsor: Idera Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-24
• Primary Completion: 2018-05-16
• Study Completion: 2018-06
• Results First Submitted: 2019-08-13
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Results First Posted: 2019-10-10
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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):

  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)
  2. Intravenous corticosteroids within 12 weeks
  3. Antimalarials (e.g., hydroxychloroquine) within 36 weeks
  4. Topical corticosteroids (excluding scalp) within 2 weeks

• Has evidence of or has required treatment for cancer (except for treated, non-invasive carcinoma of the skin or cured cervical carcinoma-in-situ) within 5 years

• Has interstitial lung disease requiring the use of supplemental oxygen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMO-8400 Dose Group 1	IMO-8400 Dose Group 1	IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
Placebo	Placebo	normal saline subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 2	IMO-8400 Dose Group 2	IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.

Primary Outcome Measures

Name	Time	Method
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM	28 weeks (24 weeks treatment + 4 weeks follow up)	Number of participants with different types of Treatment Emergent Adverse Events

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score	28 weeks (24 weeks treatment + 4 weeks follow up)	Change from baseline in mCDASI (Cutaneous Disease and Activity Severity Index) v2-Activity score as measured at Visits 2, 6, 10, 14, 18, 22 and 26 (EOT/ Week 25). Index is Clinician administered one page instrument designed to evaluate the cutaneous manifestations of DM. CDASI yields a total score that captures overall disease state, an activity score (range:0-100) that reflects the current inflammatory state of disease and a damage score (range: 0-32). The CDASI includes separate measurements for disease activity and damage and yields a total score that captures overall disease state, an activity score that reflects the current inflammatory state of disease, and a damage score. Decreases in CDASI scores are indicative of improvement. In this study, Activity Scores were measured. The scores below are averaged.

Trial Locations

Locations (20)

University of California, Irvine; 🇺🇸 Irvine, California, United States

Northwell Health; 🇺🇸 Great Neck, New York, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

University of Debrecen; 🇭🇺 Debrecen, Hungary

University of Vermont College of Medicine; 🇺🇸 Burlington, Vermont, United States

University College London Hospital; 🇬🇧 London, United Kingdom

MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool; 🇬🇧 Liverpool, United Kingdom

University of Kansas; 🇺🇸 Kansas City, Kansas, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Phoenix Neurological Associates; 🇺🇸 Phoenix, Arizona, United States