Trial of IMO-8400 in Adult Patients With Dermatomyositis

Overview

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

Full Title of Study: “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 16, 2018

Detailed Description

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

Interventions

  • Drug: IMO-8400 Dose Group 1
    • IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
  • Drug: IMO-8400 Dose Group 2
    • IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
  • Drug: Placebo
    • normal saline subcutaneous injections once a week for 24 weeks.

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • normal saline subcutaneous injections once a week for 24 weeks.
  • Experimental: IMO-8400 Dose Group 1
    • IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
  • Experimental: IMO-8400 Dose Group 2
    • IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Idera Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joanna Horobin, MD, Study Director, Idera Pharmaceuticals

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