Trial · NCT02612857
Trial of IMO-8400 in Adult Patients With Dermatomyositis
NCT02612857, Phase 2, Completed, Idera Pharmaceuticals, Inc.; results first posted 2019-10-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of IMO-8400 in Adult Patients With Dermatomyositis. Trials, record NCT02612857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02612857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of IMO-8400 in Adult Patients With Dermatomyositis
- NCT number
- NCT02612857
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Idera Pharmaceuticals, Inc.
- Conditions
- Dermatomyositis
- Interventions
- IMO-8400 Dose Group 1, IMO-8400 Dose Group 2, Placebo
- First posted
- 2015-11-24
- Last updated
- 2019-10-10
- Results first posted
- 2019-10-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | 28 weeks (24 weeks treatment + 4 weeks follow up) | Number of participants with different types of Treatment Emergent Adverse Events |
| Secondary | Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score | 28 weeks (24 weeks treatment + 4 weeks follow up) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | 28 weeks (24 weeks treatment + 4 weeks follow up) | participants | NUMBER | |
| SECONDARY | Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score | 28 weeks (24 weeks treatment + 4 weeks follow up) | Some patients did not complete all visits | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | Placebo | TEAE Severity Mild | 6 | participants | |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | IMO-8400 Dose Group 1 | TEAE Severity Mild | 4 | participants | |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | IMO-8400 Dose Group 2 | TEAE Severity Mild | 2 | participants | |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | Placebo | TEAE Severity Moderate | 4 | participants | |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | IMO-8400 Dose Group 1 | TEAE Severity Moderate | 3 | participants | |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | IMO-8400 Dose Group 2 | TEAE Severity Moderate | 6 | participants | |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | Placebo | TEAE Severity Severe | 1 | participants | |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | IMO-8400 Dose Group 1 | TEAE Severity Severe | 2 | participants | |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | IMO-8400 Dose Group 2 | TEAE Severity Severe | 2 | participants | |
| To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM | Placebo | TEAE Causality Probably Related | 3 | participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | STARTED | IMO-8400 Dose Group 1 | 9 | |
| Overall Study | STARTED | IMO-8400 Dose Group 2 | 10 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | COMPLETED | IMO-8400 Dose Group 1 | 5 | |
| Overall Study | COMPLETED | IMO-8400 Dose Group 2 | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | IMO-8400 Dose Group 1 | 4 | |
| Overall Study | NOT COMPLETED | IMO-8400 Dose Group 2 | 4 |
Source ClinicalTrials.gov
Adverse events312
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection Site Erythema | General disorders | Placebo | 1 | 11 | |
| other | Injection Site Erythema | General disorders | IMO-8400 Dose Group 1 | 7 | 9 | |
| other | Injection Site Erythema | General disorders | IMO-8400 Dose Group 2 | 10 | 10 | |
| other | Injection Site Pain | General disorders | Placebo | 0 | 11 | |
| other | Injection Site Pain | General disorders | IMO-8400 Dose Group 1 | 6 | 9 | |
| other | Injection Site Pain | General disorders | IMO-8400 Dose Group 2 | 7 | 10 | |
| other | Injection Site Induration | General disorders | Placebo | 0 | 11 | |
| other | Injection Site Induration | General disorders | IMO-8400 Dose Group 1 | 5 | 9 | |
| other | Injection Site Induration | General disorders | IMO-8400 Dose Group 2 | 5 | 10 | |
| other | Injection Site Pruritis | General disorders | Placebo | 0 | 11 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, all-cause mortality | IMO-8400 Dose Group 1 | 0 | 9 |
| Total, all-cause mortality | IMO-8400 Dose Group 2 | 0 | 10 |
| Total, other adverse events | Placebo | 11 | 11 |
| Total, other adverse events | IMO-8400 Dose Group 1 | 9 | 9 |
| Total, other adverse events | IMO-8400 Dose Group 2 | 10 | 10 |
| Total, serious adverse events | Placebo | 0 | 11 |
| Total, serious adverse events | IMO-8400 Dose Group 1 | 0 | 9 |
| Total, serious adverse events | IMO-8400 Dose Group 2 | 1 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02612857
GET https://conductscience.org/api/trials/v1/NCT02612857/results?page=2