Trial of IMO-8400 in Adult Patients With Dermatomyositis (8400-211)

October 9, 2019 updated by: Idera Pharmaceuticals, Inc.

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

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

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Debrecen, Hungary, H-4032
        • University of Debrecen
      • Liverpool, United Kingdom, L7 8TX
        • MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool
      • London, United Kingdom, WC1E6JF
        • University College London Hospital
    • Alabama
      • Birmingham, Alabama, United States, 35210
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Phoenix Neurological Associates
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine
      • Stanford, California, United States, 94063
        • Stanford Hospital and Clinics
    • District of Columbia
      • Washington, District of Columbia, United States, 20052
        • George Washington University
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University of Vermont College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
normal saline subcutaneous injections once a week for 24 weeks.
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.
IMO-8400 Dose 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.
IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 weeks (24 weeks treatment + 4 weeks follow up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 weeks (24 weeks treatment + 4 weeks follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Joanna Horobin, MD, Idera Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

May 16, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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