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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02612857 |
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Date of registration:
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18/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of IMO-8400 in Adult Patients With Dermatomyositis
8400-211 |
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Scientific title:
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02612857 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Hungary
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United Kingdom
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United States
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Contacts
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Name:
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Joanna Horobin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Idera Pharmaceuticals |
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Key inclusion & exclusion 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):
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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dermatomyositis
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Intervention(s)
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Drug: Placebo
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Drug: IMO-8400 Dose Group 1
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Drug: IMO-8400 Dose Group 2
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Primary Outcome(s)
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To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
[Time Frame: 28 weeks (24 weeks treatment + 4 weeks follow up)]
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Secondary Outcome(s)
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Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
[Time Frame: 28 weeks (24 weeks treatment + 4 weeks follow up)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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