Trial of IMO-8400 in Adult Patients With Dermatomyositis
8400-211
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis
1 other identifier
interventional
30
3 countries
20
Brief Summary
The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2015
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
November 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedResults Posted
Study results publicly available
October 10, 2019
CompletedOctober 10, 2019
October 1, 2019
2.5 years
November 18, 2015
August 13, 2019
October 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
28 weeks (24 weeks treatment + 4 weeks follow up)
Study Arms (3)
Placebo
PLACEBO COMPARATORnormal saline subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 1
EXPERIMENTALIMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 2
EXPERIMENTALIMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
Interventions
IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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):
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of Alabama
Birmingham, Alabama, 35210, United States
Phoenix Neurological Associates
Phoenix, Arizona, 85018, United States
University of California, Irvine
Irvine, California, 92697, United States
Stanford Hospital and Clinics
Stanford, California, 94063, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
University of Miami
Miami, Florida, 33136, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Kansas
Kansas City, Kansas, 66160, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University
St Louis, Missouri, 63110, United States
Northwell Health
Great Neck, New York, 11021, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Vermont College of Medicine
Burlington, Vermont, 05405, United States
University of Debrecen
Debrecen, H-4032, Hungary
MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool
Liverpool, L7 8TX, United Kingdom
University College London Hospital
London, WC1E6JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Development Operations Director
- Organization
- Idera
Study Officials
- STUDY DIRECTOR
Joanna Horobin, MD
Idera Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2015
First Posted
November 24, 2015
Study Start
November 1, 2015
Primary Completion
May 16, 2018
Study Completion
June 1, 2018
Last Updated
October 10, 2019
Results First Posted
October 10, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share