DermatomyositisPhase 28400-211NCT02612857
Trial of IMO-8400 in Adult Patients With Dermatomyositis
A Phase 2 study testing IMO-8400 Dose Group 1 and IMO-8400 Dose Group 2 in people with Dermatomyositis, run by Idera Pharmaceuticals, Inc. at 20 sites in 3 countries.
Trial summary
The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- IMO-8400 Dose Group 1 and IMO-8400 Dose Group 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 20 sitesin 3 countries
- Study dates
- Nov 2015to Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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):
Show all 12Show fewer
- 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
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States17 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21224
University of Alabama
Birmingham, Alabama, 35210
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Vermont College of Medicine
Burlington, Vermont, 05405
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
Northwell Health
Great Neck, New York, 11021
University of California, Irvine
Irvine, California, 92697
University of Kansas
Kansas City, Kansas, 66160
University of Miami
Miami, Florida, 33136
Phoenix Neurological Associates
Phoenix, Arizona, 85018
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Washington University
St Louis, Missouri, 63110
Stanford Hospital and Clinics
Stanford, California, 94063
George Washington University
Washington D.C., District of Columbia, 20052
United Kingdom2 sites
MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool
Liverpool, L7 8TX
University College London Hospital
London, WC1E6JF
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis
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
- Dermatomyositis
- Being tested
- IMO-8400 Dose Group 1, IMO-8400 Dose Group 2, Placebo
- Keywords
- dermatomyositis, IMO-8400, Pioneer
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMO-8400 Dose Group 1Drug
IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 2Drug
IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
PlaceboDrug
normal saline subcutaneous injections once a week for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | normal saline subcutaneous injections once a week for 24 weeks. Receives: Drug: Placebo |
| IMO-8400 Dose Group 1 | Experimental | IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks. Receives: Drug: IMO-8400 Dose Group 1 |
| IMO-8400 Dose Group 2 | Experimental | IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks. Receives: Drug: IMO-8400 Dose Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 28 weeks (24 weeks treatment + 4 weeks follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion16 May 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idera Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanna Horobin, MD, Study director, Idera Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612857
- Sponsor's protocol ID
- 8400-211
- Acronym
- 8400-211
- Status last verified
- Oct 2019
- First submitted
- 18 Nov 2015
- Last updated
- 10 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis
- ClinicalTrials.gov ID
- NCT02612857
- Acronym / sponsor ID
- 8400-211 / 8400-211
- Conditions
- Dermatomyositis
- Keywords
- dermatomyositis, IMO-8400, Pioneer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Idera Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Posted 10 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebonormal saline subcutaneous injections once a week for 24 weeks. |
| IMO-8400 Dose Group 1 | Experimental | Drug: IMO-8400 Dose Group 1IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks. |
| IMO-8400 Dose Group 2 | Experimental | Drug: IMO-8400 Dose Group 2IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMO-8400 Dose Group 1IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks. | Drug | IMO-8400 Dose Group 1 |
| IMO-8400 Dose Group 2IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks. | Drug | IMO-8400 Dose Group 2 |
| Placebonormal saline subcutaneous injections once a week for 24 weeks. | Drug | Placebo |
Primary outcome
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
Time frame: 28 weeks (24 weeks treatment + 4 weeks follow up)
Number of participants with different types of Treatment Emergent Adverse Events
1 secondary outcome
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Time frame: 28 weeks (24 weeks treatment + 4 weeks follow up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Horobin, MD study director
Idera Pharmaceuticals
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMO-8400 Dose Group 1 and IMO-8400 Dose Group 2 in people with Dermatomyositis, run by Idera Pharmaceuticals, Inc. at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, United Kingdom, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM (time frame: 28 weeks (24 weeks treatment + 4 weeks follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.