Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis (DETERMINE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03813160 |
Recruitment Status :
Active, not recruiting
First Posted : January 23, 2019
Last Update Posted : August 13, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dermatomyositis | Drug: Lenabasum 20 mg Drug: Lenabasum 5 mg Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 176 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis |
Actual Study Start Date : | December 17, 2018 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | September 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily
|
Drug: Lenabasum 20 mg
oral capsule
Other Names:
|
Experimental: Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily
|
Drug: Lenabasum 5 mg
oral capsule
Other Names:
|
Placebo Comparator: Placebo
Subjects will receive placebo twice daily
|
Drug: Placebo
oral capsule |
- Efficacy of lenabasum compared to placebo as measured by Total Improvement Score (TIS) [ Time Frame: Week 52 ]TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
- Efficacy of lenabasum compared to placebo as measured by Mean MMT-8 Score [ Time Frame: Week 52 ]Strength in 8 muscle groups will be assessed on a 0 - 10 point scale; lower score is "weaker" and higher score is "stronger."
- Efficacy of lenabasum compared to placebo as measured by Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score [ Time Frame: Week 52 ]The CDASI is a validated outcome measure that systematically quantifies cutaneous DM activity. Disease involvement in 15 different anatomical locations is rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia are also captured. Disease activity is scored from 0 to 100; higher scores indicate greater disease severity.
- Efficacy of lenabasum compared to placebo as measured by Investigator Global Assessment (IGA) scale of skin activity [ Time Frame: Week 52 ]The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.
- Efficacy of lenabasum compared to placebo as measured by Short Form-36 (SF-36) physical functioning domain score [ Time Frame: Week 52 ]
- Efficacy of lenabasum compared to placebo as measured by corticosteroid dose [ Time Frame: Week 52 ]
- Efficacy of lenabasum compared to placebo as measured by Forced Vital Capacity (FVC) % predicted [ Time Frame: Week 52 ]
- Safety of lenabasum compared to placebo as measured by Adverse Events (AEs) associated with lenabasum treatment [ Time Frame: From initiation of treatment (Day 1) to end of treatment (Week 52) ]
- Tolerability of lenabasum compared to placebo as measured by number of subjects who permanently discontinue study product due to AEs probably- or definitely-related to treatment [ Time Frame: From initiation of treatment (Day 1) to end of treatment (Week 52) ]

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 and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Fulfill one of the following criteria for dermatomyositis:
- Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)
- ACR/EULAR criteria (Lundberg et al, 2017)
-
Disease activity/severity fulfills one of the following three criteria:
- MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale [VAS]) and MMT-8 score ≤ 142 (out of 150 total possible)
- Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each)
- MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of > 14
-
Stable doses of immunosuppressive medications for DM as defined by:
- Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1
- Unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before Screening
Exclusion Criteria:
- Unstable DM or DM with end-stage organ involvement at Screening or Visit 1
- Significant diseases or conditions other than DM that may influence response to the study drug or safety
-
Any of the following values for laboratory tests at Screening:
- A positive pregnancy test (or at Visit 1)
- Hemoglobin < 9 g/dL in males and < 8 g/dL in females
- Neutrophils < 1.0 × 10^9/L
- Platelets < 75 × 10^9/L
- Creatinine clearance < 50 mL/min on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement

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): NCT03813160

Principal Investigator: | Victoria P Werth, MD | University of Pennsylvania | |
Principal Investigator: | Chester V Oddis, MD | University of Pittsburgh Department of Medicine/Division of Rheumatology |
Responsible Party: | Corbus Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT03813160 |
Other Study ID Numbers: |
JBT101-DM-002 |
First Posted: | January 23, 2019 Key Record Dates |
Last Update Posted: | August 13, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
dermatomyositis cannabinoid receptor type 2 agonist JBT-101 lenabasum |
Dermatomyositis Polymyositis Myositis Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Connective Tissue Diseases Skin Diseases |