DermatomyositisPhase 2NCT02466243
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
A Phase 2 study testing JBT-101 in people with Dermatomyositis, run by Corbus Pharmaceuticals Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- JBT-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 29 Jan 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons
Who cannot join
- Significant diseases or conditions other than DM that may influence response to the study product or safety;
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Perlman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
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
The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.
Read the detailed description
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.
- Conditions
- Dermatomyositis
- Being tested
- JBT-101, Placebo
- Keywords
- JBT-101, lenabasum, dermatomyositis
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JBT-101Drug
Also called lenabasum
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| JBT-101 | Experimental | 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. Receives: Drug: JBT-101 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A.
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
Measured: Part A: 84-day treatment period (Change from the Baseline CDSAI score at Day 84)
Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Number of participants with treatment emergent adverse events were assessed as a measure of safety and tolerability
Measured: Part A: to Day 84
Secondary outcomes (1)
Change in Patient-reported Outcomes From Baseline at 84 Days for Part A
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.
Measured: Part A: 84-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2017
- Study completion29 Jan 2021
Why it stopped: Sponsor terminated open-label extension.
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corbus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Victoria Werth, M.D., Principal investigator, University of Pennsylvania Perlman School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466243
- Sponsor's protocol ID
- JBT101-DM-001
- Other IDs
- 116313, R21AR066286
- Status last verified
- Dec 2022
- First submitted
- 2 Jun 2015
- Last updated
- 19 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stone CJ, Ahuja G, Lopes Almeida Gomes L, Poroye J, Faden DF, Xie L, Feng R, White B, Werth VP. Long-Term Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: Follow-Up Data from a 3-Year Open-Label Extension Study. JID Innov. 2024 Sep 5;5(1):100311. doi: 10.1016/j.xjidi.2024.100311. eCollection 2025 Jan.
PubMed 39403556Werth VP, Hejazi E, Pena SM, Haber J, Zeidi M, Reddy N, Okawa J, Feng R, Bashir MM, Gebre K, Jadoo AS, Concha JSS, Dgetluck N, Constantine S, White B. Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial. J Invest Dermatol. 2022 Oct;142(10):2651-2659.e1. doi: 10.1016/j.jid.2022.03.029. Epub 2022 Apr 29.
PubMed 35490744
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02466243
- Acronym / sponsor ID
- JBT101-DM-001
- Conditions
- Dermatomyositis
- Keywords
- JBT-101, lenabasum, dermatomyositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated open-label extension.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Corbus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Pennsylvania
- Study start
- Jun 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 19 Jan 2023
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 evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JBT-101 | Experimental | Drug: JBT-101Part 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. |
| Placebo | Placebo comparator | Drug: PlaceboPart 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
- Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons
Key exclusion criteria (10 listed)
- Significant diseases or conditions other than DM that may influence response to the study product or safety;
- Any one of the following values for laboratory tests at Screening:
- 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.
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 |
|---|---|---|
| JBT-101Also: lenabasumPart 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. | Drug | JBT-101 |
| PlaceboPart 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. | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Change in Patient-reported Outcomes From Baseline at 84 Days for Part A
Time frame: Part A: 84-day treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39403556Stone CJ, Ahuja G, Lopes Almeida Gomes L, Poroye J, Faden DF, Xie L, Feng R, White B, Werth VP. Long-Term Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: Follow-Up Data from a 3-Year Open-Label Extension Study. JID Innov. 2024 Sep 5;5(1):100311. doi: 10.1016/j.xjidi.2024.100311. eCollection 2025 Jan.
- Derived from this study: PubMed 35490744Werth VP, Hejazi E, Pena SM, Haber J, Zeidi M, Reddy N, Okawa J, Feng R, Bashir MM, Gebre K, Jadoo AS, Concha JSS, Dgetluck N, Constantine S, White B. Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial. J Invest Dermatol. 2022 Oct;142(10):2651-2659.e1. doi: 10.1016/j.jid.2022.03.029. Epub 2022 Apr 29.
Related trials for Dermatomyositis
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Active, not recruitingPhase 2
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
Dermatomyositis, Myositis
RecruitingObservational study
Natural History of Inflammatory Muscle Diseases
Inflammation In Skeletal Muscle
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
RecruitingPhase 2
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
Dermatomyositis
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.
Victoria Werth, M.D. principal investigator
University of Pennsylvania Perlman School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JBT-101 in people with Dermatomyositis, run by Corbus Pharmaceuticals Inc. at 1 site in United States.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 19 Jan 2023). 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?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02466243, which also lists 2 linked publications.
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 19 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.