Trial of IMO-8400 in Adult Patients With Dermatomyositis

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

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

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

Conditions
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Dermatomyositis

Intervention / Treatment
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* Drug: IMO-8400 Dose Group 1
* Drug: IMO-8400 Dose Group 2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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): 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) Intravenous corticosteroids within 12 weeks Antimalarials (e.g., hydroxychloroquine) within 36 weeks 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>normal saline subcutaneous injections once a week for 24 weeks. | Drug: Placebo<br>* normal saline subcutaneous injections once a week for 24 weeks.<br>|
| Experimental: IMO-8400 Dose Group 1<br>IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks. | Drug: IMO-8400 Dose Group 1<br>* IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.<br>|
| Experimental: IMO-8400 Dose Group 2<br>IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks. | Drug: IMO-8400 Dose Group 2<br>* IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pioneer, dermatomyositis, IMO-8400