Trial · NCT02466243
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
NCT02466243, Phase 2, Terminated, Corbus Pharmaceuticals Inc.; results first posted 2023-01-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis. Trials, record NCT02466243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02466243
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
- NCT number
- NCT02466243
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Corbus Pharmaceuticals Inc.
- Conditions
- Dermatomyositis
- Interventions
- JBT-101, Placebo
- First posted
- 2015-06-09
- Last updated
- 2023-01-19
- Results first posted
- 2023-01-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A. | Part A: 84-day treatment period (Change from the Baseline CDSAI score at Day 84) | The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity, In the CDASI, DM skin disease activity is scored from 0 to 100 based on the physician's evaluation of erythema, scale, and erosion or ulceration at 15 anatomic locations as well as alopecia, Gottron's sign or papules on the hands, and periungual changes. A 5-point or greater decrease in the CDASI activity score indicates clinically relevant improvement based on statistical analysis using a receiver operating characteristic curve to maximize sensitivity and specificity |
| Primary | Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Part A: to Day 84 | Number of participants with treatment emergent adverse events were assessed as a measure of safety and tolerability |
| Secondary | Change in Patient-reported Outcomes From Baseline at 84 Days for Part A | Part A: 84-day treatment period | LS mean (SE) change from baseline to Week 6 (Day 84) for lenabasum vs. placebo using a mixed model repeated measures analysis The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage, In the CDASI, the Damage Score is scored from 0 to 32 based on the physician's evaluation of poikiloderma and calcinosis. 0 representing no damage and 32 representing the greatest level of damage. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A. | Part A: 84-day treatment period (Change from the Baseline CDSAI score at Day 84) | modified intent-to-treat population LS mean (SE) at Day 84 | CDASI Activity Score | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Part A: to Day 84 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Patient-reported Outcomes From Baseline at 84 Days for Part A | Part A: 84-day treatment period | modified intent to treat population | CDASI Damage Score | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A. | Lenabasum | -8.0 | Standard Error 8.16 | CDASI Activity Score | |
| Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A. | Placebo | -5.5 | Standard Error 5.56 | CDASI Activity Score | |
| Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Lenabasum | Any TEAE | 11 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Placebo | Any TEAE | 8 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Lenabasum | Any serious TEAE | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Placebo | Any serious TEAE | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Lenabasum | Any TEAE leading to discontinuation | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Placebo | Any TEAE leading to discontinuation | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Lenabasum | Any severe TEAE | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Placebo | Any severe TEAE | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A Treatment Period (Double Blind) | STARTED | JBT-101 | 11 | |
| Part A Treatment Period (Double Blind) | STARTED | Placebo | 11 | |
| Part A Treatment Period (Double Blind) | COMPLETED | JBT-101 | 11 | |
| Part A Treatment Period (Double Blind) | COMPLETED | Placebo | 11 | |
| Part A Treatment Period (Double Blind) | NOT COMPLETED | JBT-101 | 0 | |
| Part A Treatment Period (Double Blind) | NOT COMPLETED | Placebo | 0 | |
| Part B Open-label Treatment Period | STARTED | JBT-101 | 11 | |
| Part B Open-label Treatment Period | STARTED | Placebo | 10 | |
| Part B Open-label Treatment Period | COMPLETED | JBT-101 | 0 | |
| Part B Open-label Treatment Period | COMPLETED | Placebo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
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 | Diarrhoea | Gastrointestinal disorders | JBT-101 | 3 | 11 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 11 | 2 |
| other | Dry mouth | Gastrointestinal disorders | JBT-101 | 4 | 11 | 4 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 11 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | JBT-101 | 2 | 11 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 0 | 11 | 0 |
| other | Nausea | Gastrointestinal disorders | JBT-101 | 1 | 11 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 11 | 2 |
| other | Fatigue | General disorders | JBT-101 | 1 | 11 | 1 |
| other | Fatigue | General disorders | Placebo | 3 | 11 | 3 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | JBT-101 | 0 | 11 |
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, other adverse events | JBT-101 | 11 | 11 |
| Total, other adverse events | Placebo | 11 | 11 |
| Total, serious adverse events | JBT-101 | 0 | 11 |
| Total, serious adverse events | Placebo | 0 | 11 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AR066286 | Treatment of Dermatomyositis with Ajulemic Acid, a Non-Psychoactive Cannabinoid | WERTH, VICTORIA P | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2014 to 2016 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| JBT-101 vs Placebo: deaths from any cause | Trial comparisons |
| JBT-101 vs Placebo: serious adverse events | Trial comparisons |
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/NCT02466243
GET https://conductscience.org/api/trials/v1/NCT02466243/registered