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

Idera Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Dermatomyositis

Treatments: Drug: IMO-8400 Dose Group 1; Drug: Placebo; Drug: IMO-8400 Dose Group 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02612857

8400-211

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

normal saline subcutaneous injections once a week for 24 weeks.

Treatment:

Drug: Placebo

IMO-8400 Dose Group 1

Experimental group

Description:

IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.

Treatment:

Drug: IMO-8400 Dose Group 1

IMO-8400 Dose Group 2

Experimental group

Description:

IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.

Treatment:

Drug: IMO-8400 Dose Group 2