search
Back to results

Trial of IMO-8400 in Adult Patients With Dermatomyositis (8400-211)

Primary Purpose

Dermatomyositis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IMO-8400 Dose Group 1
IMO-8400 Dose Group 2
Placebo
Sponsored by
Idera Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatomyositis focused on measuring dermatomyositis, IMO-8400, Pioneer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Phoenix Neurological Associates
  • University of California, Irvine
  • Stanford Hospital and Clinics
  • George Washington University
  • University of Miami
  • Northwestern University
  • University of Kansas
  • Johns Hopkins University
  • Brigham and Women's Hospital
  • University of Michigan
  • Washington University
  • Northwell Health
  • Ohio State University
  • University of Pittsburgh
  • Medical University of South Carolina
  • University of Vermont College of Medicine
  • University of Debrecen
  • MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool
  • University College London Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

IMO-8400 Dose Group 1

IMO-8400 Dose Group 2

Arm Description

normal saline subcutaneous injections once a week for 24 weeks.

IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.

IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 18, 2015
Last Updated
October 9, 2019
Sponsor
Idera Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02612857
Brief Title
Trial of IMO-8400 in Adult Patients With Dermatomyositis
Acronym
8400-211
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idera Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis
Keywords
dermatomyositis, IMO-8400, Pioneer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
normal saline subcutaneous injections once a week for 24 weeks.
Arm Title
IMO-8400 Dose Group 1
Arm Type
Experimental
Arm Description
IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
Arm Title
IMO-8400 Dose Group 2
Arm Type
Experimental
Arm Description
IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
IMO-8400 Dose Group 1
Intervention Description
IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
IMO-8400 Dose Group 2
Intervention Description
IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
normal saline subcutaneous injections once a week for 24 weeks.
Primary Outcome Measure Information:
Title
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
Description
Number of participants with different types of Treatment Emergent Adverse Events
Time Frame
28 weeks (24 weeks treatment + 4 weeks follow up)
Secondary Outcome Measure Information:
Title
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Description
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.
Time Frame
28 weeks (24 weeks treatment + 4 weeks follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Horobin, MD
Organizational Affiliation
Idera Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35210
Country
United States
Facility Name
Phoenix Neurological Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Vermont College of Medicine
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool
City
Liverpool
ZIP/Postal Code
L7 8TX
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
WC1E6JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Trial of IMO-8400 in Adult Patients With Dermatomyositis

We'll reach out to this number within 24 hrs