CompletedNCT026128578400-211Updated Oct 10, 2019Results posted

Trial of IMO-8400 in Adult Patients With Dermatomyositis

A Phase 2 interventional study of IMO-8400 Dose Group 1 and IMO-8400 Dose Group 2 in Dermatomyositis, sponsored by Idera Pharmaceuticals, Inc.. Completed at 20 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-10.

Sponsored by Idera Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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

Read the detailed description

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

Conditions studied

Dermatomyositis

Browse trials for

Dermatomyositis 171

Keywords

dermatomyositis
IMO-8400
Pioneer

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 30 participants (actual)

Study arms

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

Interventions

DrugIMO-8400 Dose Group 1
IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
DrugIMO-8400 Dose Group 2
IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
DrugPlacebo
normal saline subcutaneous injections once a week for 24 weeks.

What researchers measure

Primary outcomes

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
Time frame: 28 weeks (24 weeks treatment + 4 weeks follow up)

Secondary outcomes

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.
Time frame: 28 weeks (24 weeks treatment + 4 weeks follow up)

Results

Posted Oct 10, 2019

Participant flow

Participant flow — Overall Study
Milestone	Placebo	IMO-8400 Dose Group 1	IMO-8400 Dose Group 2
Started	11	9	10
Completed	8	5	6
Not completed	3	4	4

Outcome measures

PrimaryTo Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM

Number of participants with different types of Treatment Emergent Adverse Events

Time frame:: 28 weeks (24 weeks treatment + 4 weeks follow up)
Reported as:: Number · participants

To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
participants	Placebo	IMO-8400 Dose Group 1	IMO-8400 Dose Group 2
TEAE Severity Mild	6	4	2
TEAE Severity Moderate	4	3	6
TEAE Severity Severe	1	2	2
TEAE Causality Probably Related	3	9	9
TEAE Causality Possibly Related	3	0	1
TEAE Causality Not Related	5	0	0
Injection Site Reaction AE	2	8	10
Serious TEAE	0	0	1
TEAE Leading to Treatment Discontinuation	1	3	1
TEAE Leading to Death	0	0	0

SecondaryChange 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.

Time frame:: 28 weeks (24 weeks treatment + 4 weeks follow up)
Reported as:: Least squares mean · units on a scale

Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
units on a scale	Placebo	IMO-8400 Dose Group 1	IMO-8400 Dose Group 2
Baseline	30.1 (29.60 to 30.56)	31.3 (30.72 to 31.79)	30.7 (30.20 to 31.22)
Visit 6	28.0 (25.23 to 30.76)	28.5 (25.27 to 31.66)	27.8 (24.91 to 30.71)
Visit 10	27.7 (23.66 to 31.83)	30.4 (25.54 to 35.26)	25.7 (21.40 to 30.07)
Visit 14	28.9 (24.46 to 33.35)	29.4 (24.17 to 34.70)	21.6 (16.75 to 26.51)
Visit 18	30.5 (25.71 to 35.22)	26.0 (19.98 to 32.09)	22.4 (17.24 to 27.63)
Visit 22	26.6 (20.59 to 32.61)	25.3 (18.40 to 32.13)	24.6 (18.39 to 30.82)
Visit 26	26.0 (20.97 to 31.04)	22.1 (16.19 to 28.01)	23.0 (17.38 to 28.61)
Across Visit	28.3 (24.74 to 31.77)	27.6 (23.41 to 31.72)	25.1 (21.36 to 28.90)

Adverse events

Collected over 28 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/11 (0%)	0/11 (0%)	11/11 (100%)
IMO-8400 Dose Group 1	0/9 (0%)	0/9 (0%)	9/9 (100%)
IMO-8400 Dose Group 2	0/10 (0%)	1/10 (10%)	10/10 (100%)

Most frequent serious events

Most frequent serious events
Event	Placebo	IMO-8400 Dose Group 1	IMO-8400 Dose Group 2
Wrist FractureInjury, poisoning and procedural complications	0/11	0/9	1/10

Most frequent other events

Showing 10 of 103

Most frequent other events
Event	Placebo	IMO-8400 Dose Group 1	IMO-8400 Dose Group 2
Injection Site ErythemaGeneral disorders	1/11	7/9	10/10
Injection Site PainGeneral disorders	0/11	6/9	7/10
Injection Site IndurationGeneral disorders	0/11	5/9	5/10
Injection Site PruritisGeneral disorders	0/11	3/9	5/10
Injection Site BruisingGeneral disorders	0/11	2/9	4/10
FatigueGeneral disorders	0/11	3/9	2/10
Upper Respiratory Tract InfectionInfections and infestations	1/11	3/9	2/10
Injection Site VesiclesGeneral disorders	0/11	0/9	3/10
HeadacheNervous system disorders	1/11	2/9	3/10
PruritusSkin and subcutaneous tissue disorders	2/11	2/9	2/10

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Placebo	IMO-8400 Dose Group 1	IMO-8400 Dose Group 2	Total
Mean	51.3 ± 10.55	48.3 ± 14.23	54.6 ± 14.12	51.5 ± 12.75

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	IMO-8400 Dose Group 1	IMO-8400 Dose Group 2	Total
Female	7	7	9	23
Male	4	2	1	7

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	IMO-8400 Dose Group 1	IMO-8400 Dose Group 2	Total
Hispanic or Latino	1	1	1	3
Not Hispanic or Latino	10	8	9	27
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Placebo	IMO-8400 Dose Group 1	IMO-8400 Dose Group 2	Total
Hungary	2	1	2	5
United States	8	8	8	24
United Kingdom	1	0	0	1

Study locations

20 sites

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, 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
Saint 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

References and documents

Study documents

Statistical analysis plan · Apr 26, 2018
Study protocol · Jan 27, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT02612857
Lead sponsor: Idera Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Nov 24, 2015
Start date: Nov 2015
Primary completion: May 16, 2018
Completion: Jun 2018
Results posted: Oct 10, 2019
Last update: Oct 10, 2019

Study contacts

Joanna Horobin, MD

study director · Idera Pharmaceuticals

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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