Phase 2
N=30
Trial of IMO-8400 in Adult Patients With Dermatomyositis
Dermatomyositis
Bottom Line
View on ClinicalTrials.gov: NCT02612857 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Oct 2019
Primary outcome: Primary: To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM — 6; 4; 2; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IMO-8400 Dose Group 1 (Drug); IMO-8400 Dose Group 2 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Idera Pharmaceuticals, Inc.
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM |
6; 4; 2; 4; 3; 6 | — |
| SECONDARY Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score |
30.1; 31.3; 30.7; 28.0; 28.5; 27.8 | — |
Summary
The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.
Eligibility 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):
- 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
Data sourced from ClinicalTrials.gov (NCT02612857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.