Trial of IMO-8400 in Adult Patients With Dermatomyositis

Dermatomyositis Clinical Trial

— 8400-211  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612857
• Other study ID #: 8400-211
• Status: Completed
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: June 2018

Study information

• Verified date: October 2019
• Source: Idera Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis

Intervention

Drug:
• IMO-8400 Dose Group 1
IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
• IMO-8400 Dose Group 2
IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
• Placebo
normal saline subcutaneous injections once a week for 24 weeks.

Locations

Country	Name	City	State
Hungary	University of Debrecen	Debrecen
United Kingdom	MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool	Liverpool
United Kingdom	University College London Hospital	London
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Vermont College of Medicine	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Northwell Health	Great Neck	New York
United States	University of California, Irvine	Irvine	California
United States	University of Kansas	Kansas City	Kansas
United States	University of Miami	Miami	Florida
United States	Phoenix Neurological Associates	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	Stanford Hospital and Clinics	Stanford	California
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Idera Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Hungary,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)