Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
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ClinicalTrials.gov Identifier: NCT02466243 |
Recruitment Status :
Terminated
(Sponsor terminated open-label extension.)
First Posted : June 9, 2015
Results First Posted : January 19, 2023
Last Update Posted : January 19, 2023
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Condition or disease | Intervention/treatment | Phase |
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Dermatomyositis | Drug: JBT-101 Drug: Placebo | Phase 2 |
Part A: An interventional, double-blind, randomized, placebo-control design will be used to test JBT-101 in about 22 eligible male or female subjects ≥ 18 and ≤ 70 years of age with moderate-to-severe active skin-predominant dermatomyositis.
Part B: A one-year open-label design to test JBT-101 in subjects who completed Part A without permanent discontinuation of study product because of safety or tolerability reasons.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis |
Study Start Date : | June 2015 |
Actual Primary Completion Date : | August 2017 |
Actual Study Completion Date : | January 29, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: JBT-101
Part A: JBT-101 20 mg capsule once a day on Days 1-28, then 20 mg capsule twice a day on Days 29-84. Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE. |
Drug: JBT-101
Part A: 20 mg once daily on Days 1-28, then 20 mg twice daily on Days 29-84. Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE. Other Name: lenabasum |
Placebo Comparator: Placebo
Part A: Placebo capsule once a day on Days 1-28, then placebo capsule twice a day on Days 29-84. Part B: Placebo twice daily on Days 1 - 365 of the OLE. |
Drug: Placebo
Part A: Once daily on Days 1-28, then twice daily on Days 29-84. Part B: Placebo twice daily on Days 1 - 365 of the OLE. |
- Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A. [ Time Frame: 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
- Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Part A: to Day 84 ]Number of participants with treatment emergent adverse events were assessed as a measure of safety and tolerability
- Change in Patient-reported Outcomes From Baseline at 84 Days for Part A [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Part A):
- CDASI activity score ≥ 14;
- No difficulty with lifting or walking, and no more than 1.5 x the upper limit of normal of creatine phosphokinase or aldolase;
- Failed at least 3 months treatment with hydroxychloroquine;
- Stable treatment for dermatomyositis for at least 28 days before Visit 1 (Day 1).
Inclusion Criteria (Part B):
- Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons
Exclusion Criteria (Part A and B):
- Significant diseases or conditions other than DM that may influence response to the study product or safety;
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Any one of the following values for laboratory tests at Screening:
- A positive pregnancy test (or at Visit 1);
- Hemoglobin < 10 g/dL;
- Neutrophils < 1.0 x 10^9/L;
- Platelets < 75 x 10^9/L;
- Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation;
- Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 x upper normal limit;
- Total bilirubin ≥ 1.5 x upper limit of normal.
- Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466243
United States, Pennsylvania | |
University of Pennsylvania Perlman School of Medicine | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Victoria Werth, M.D. | University of Pennsylvania Perlman School of Medicine |
Documents provided by Corbus Pharmaceuticals Inc.:
Responsible Party: | Corbus Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT02466243 |
Other Study ID Numbers: |
JBT101-DM-001 116313 ( Registry Identifier: Investigation New Drug Application (IND) ) R21AR066286 ( U.S. NIH Grant/Contract ) |
First Posted: | June 9, 2015 Key Record Dates |
Results First Posted: | January 19, 2023 |
Last Update Posted: | January 19, 2023 |
Last Verified: | December 2022 |
JBT-101, lenabasum, dermatomyositis |
Dermatomyositis Polymyositis Myositis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Connective Tissue Diseases Skin Diseases |
Lenabasum Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |