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
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Among 94 studies in Dermatomyositis with a site in United States — 30 open to participants now, 33 under way, 6 of them phase 3. Dermatomyositis · United States.
Among the 94 studies in Dermatomyositis with a site in United States, this one is the 35th largest by enrollment of the 73 interventional ones that give a count, is one of 6 that started in 2015, is one of 31 in phase 2, and was the 37th registered.
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
Browse Dermatomyositis studies →30 of the 94 studies in Dermatomyositis with a site in United States are open now. Recruiting first, the newest first:
National Institute of Environmental Health Sciences (NIEHS) · Sites in United States
Ages 18–62
Fate Therapeutics · Sites in United States
Ages 18–70
University of Miami · Sites in United States
Ages 18+
Cartesian Therapeutics · Sites in United States
Ages 12+
Restem, LLC. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 50 Dermatomyositis studies recruiting now, 24 (48%) set no upper age limit and 16 (32%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
94 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 42 · Phase 3 17 · Phase 4 2
First in 1990; this study’s year is marked. 6 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 35 across 130 interventional studies indexed under Dermatomyositis.
Median enrollment 25 across the 73 interventional studies, 540 across the 18 observational. Of the 55 that completed or were terminated, 26 (47%) have results posted.
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40 of 94 have an industry lead sponsor. The 10 most frequent:
Idera Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Idera Pharmaceuticals, Inc. has 1 study filed under Dermatomyositis — fewer than ten, so there is no comparison to draw.
5 of the studies in Dermatomyositis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06284954argenxA Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis | 2026-11 |
| NCT06371417Chugai PharmaceuticalPhase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) | 2027-03-31 |
| NCT06298019Stanford UniversityStudy of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis | 2027-04 |
| NCT06916806AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | 2027-05-05 |
| NCT07486869University of MiamiEmapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study | 2027-07 |
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Among the 94 studies in Dermatomyositis with a site in United States, from their registry updates:
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The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.
This study will evaluate the safety and efficacy of IMO-8400 in adults with active dermatomyositis (DM).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Has received one or more of following prohibited treatments within the interval noted prior to Screening (Visit 1):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
normal saline subcutaneous injections once a week for 24 weeks.
Drug: Placebo
IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
Drug: IMO-8400 Dose Group 1
IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
Drug: IMO-8400 Dose Group 2
IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
normal saline subcutaneous injections once a week for 24 weeks.
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)
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)
| 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 |
Number of participants with different types of Treatment Emergent Adverse Events
| 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 |
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.
| 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) |
Collected over 28 weeks. Non-serious events are listed at a 0% frequency threshold.
| 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%) |
| Event | Placebo | IMO-8400 Dose Group 1 | IMO-8400 Dose Group 2 |
|---|---|---|---|
| Wrist FractureInjury, poisoning and procedural complications | 0/11 | 0/9 | 1/10 |
| 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 |
| 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(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)(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(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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2015 to primary completion in May 2018, 30 months.
Results were first posted in Oct 2019, 1 year 4 months after primary completion.
Of 19 phase 2 interventional studies under Dermatomyositis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 52. This study's 30 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bazlitoran
Idera Pharmaceuticals, Inc.