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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02612857
First Posted: November 24, 2015
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.
  Purpose
The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.

Condition Intervention Phase
Dermatomyositis Drug: IMO-8400 Dose Group 1 Drug: IMO-8400 Dose Group 2 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis

Resource links provided by NLM:


Further study details as provided by Idera Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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) ]

Estimated Enrollment: 36
Actual Study Start Date: November 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: May 16, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
normal saline subcutaneous injections once a week for 24 weeks.
Drug: 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.
Drug: IMO-8400 Dose Group 1
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.
Drug: IMO-8400 Dose Group 2
IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612857


  Show 20 Study Locations
Sponsors and Collaborators
Idera Pharmaceuticals, Inc.
Investigators
Study Director: Joanna Horobin, MD Idera Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02612857     History of Changes
Other Study ID Numbers: 8400-211
First Submitted: November 18, 2015
First Posted: November 24, 2015
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Idera Pharmaceuticals, Inc.:
dermatomyositis
IMO-8400
Pioneer

Additional relevant MeSH terms:
Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases