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

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ClinicalTrials.gov Identifier: NCT02612857
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Dermatomyositis Drug: IMO-8400 Dose Group 1 Drug: IMO-8400 Dose Group 2 Drug: Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Actual Study Start Date : November 2015
Estimated Primary Completion Date : May 16, 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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) ]
  2. Change from baseline in CDASI Activity score [ Time Frame: 28 weeks (24 weeks treatment + 4 weeks follow up) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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

Additional Information:
Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02612857     History of Changes
Other Study ID Numbers: 8400-211
First Posted: November 24, 2015    Key Record Dates
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