Clinical trial NCT02612857: Trial of IMO-8400 in Adult Patients With Dermatomyositis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatomyositis
Keywords: dermatomyositis
IMO-8400
Pioneer
Lead sponsor: Idera Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

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):

  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

Primary outcomes:
measure: To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
timeFrame: 28 weeks (24 weeks treatment + 4 weeks follow up)
Secondary outcomes:
measure: Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
timeFrame: 28 weeks (24 weeks treatment + 4 weeks follow up)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Neurological Associates
state: Arizona
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Liverpool
country: United Kingdom
facility: MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: Idera Pharmaceuticals
name: Joanna Horobin, MD
role: STUDY_DIRECTOR
References: