Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis (DETERMINE)
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ClinicalTrials.gov Identifier: NCT03813160 |
Recruitment Status :
Active, not recruiting
First Posted : January 23, 2019
Last Update Posted : August 13, 2020
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Condition or disease | Intervention/treatment | Phase |
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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
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Drug: Lenabasum 20 mg
oral capsule
Other Names:
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Experimental: Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily
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Drug: Lenabasum 5 mg
oral capsule
Other Names:
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Placebo Comparator: Placebo
Subjects will receive placebo twice daily
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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:
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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)
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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
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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
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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

United States, Arizona | |
HonorHealth Neurology | |
Phoenix, Arizona, United States, 85018 | |
Mayo Clinic | |
Scottsdale, Arizona, United States, 85259 | |
United States, California | |
Attune Health Center | |
Beverly Hills, California, United States, 90211 | |
UCLA Division of Rheumatology | |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
Denver Arthritis Clinic | |
Denver, Colorado, United States, 80230 | |
United States, District of Columbia | |
Georgetown University | |
Washington, District of Columbia, United States, 20001 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
University of Miami | |
Miami, Florida, United States, 33136 | |
University of South Florida | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Louisiana | |
DelRicht Research | |
New Orleans, Louisiana, United States, 70115 | |
United States, Maryland | |
Johns Hopkins Bayview Medical Center | |
Baltimore, Maryland, United States, 21224 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Minnesota | |
University of Minnesota, Division of Rheumatic and Autoimmune Diseases | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Washington University in St. Louis | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Hospital for Special Surgery | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pittsburgh, Division of Rheumatology | |
Pittsburgh, Pennsylvania, United States, 15261 | |
United States, South Carolina | |
MUSC: Department of Neurology | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
Austin Neuromuscular Center | |
Austin, Texas, United States, 78756 | |
United States, Wisconsin | |
Rheumatic Disease Center | |
Glendale, Wisconsin, United States, 53217 | |
Bulgaria | |
University Hospital "Kaspela" Rheumatology Clinic | |
Plovdiv, Bulgaria | |
UMHAT "St. Ivan Rilski" | |
Sofia, Bulgaria | |
UMHAT | |
Stara Zagora, Bulgaria, 6000 | |
Canada, British Columbia | |
University of British Columbia, Dept. of Dermatology and Skin Science | |
Vancouver, British Columbia, Canada, V5Z 4E8 | |
Czechia | |
Revmatologicky ustav | |
Prague, Czechia, 12850 | |
Germany | |
Charite-Universitatsmedizin | |
Berlin, Germany | |
University Hospital Erlangen Nuremberg | |
Erlangen, Germany, D- 91054 | |
University Medical Center Goettingen | |
Göttingen, Germany | |
Hungary | |
University of Debrecen | |
Debrecen, Hungary | |
Italy | |
University Hospital Policlinico-Vittorio Emanuele | |
Catania, Italy, 95121 | |
Fondazione Policlinico Universitario A.Gemelli-IRCCS | |
Roma, Italy, 00168 | |
Japan | |
Gunma University Hospital | |
Gunma, Japan | |
Hokkaido University Hospital | |
Hokkaido, Japan | |
Yokohama City University Hospital | |
Kanagawa, Japan | |
Kyoto University Hospital | |
Kyoto, Japan | |
Tohoku University Hospital | |
Miyagi, Japan | |
Osaka University Hospital | |
Osaka, Japan | |
Keio University Hospital | |
Tokyo, Japan | |
Nippon Medical School Hospital | |
Tokyo, Japan | |
Wakayama Medical Hospital | |
Wakayama, Japan | |
Korea, Republic of | |
Inha University Hospital | |
Incheon, Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 03080 | |
Hanyang University Hospital | |
Seoul, Korea, Republic of | |
Seoul St. Mary's Hospital | |
Seoul, Korea, Republic of | |
Poland | |
KLIMED | |
Bialystok, Poland | |
Kliniczny Szpital Wojewodzki Nr 1. im Fryderyka Chopina Klinika Dermatologii | |
Rzeszow, Poland, 35-055 | |
KLIMED | |
Łomża, Poland, 18-404 | |
Spain | |
Vall d'Hebron General Hospital | |
Barcelona, Spain | |
Hospital 12 Octubre | |
Madrid, Spain | |
Sweden | |
Karolinska University Hospital, Rheumatology Clinic | |
Stockholm, Sweden | |
United Kingdom | |
King's College Hospital NHS Foundation Trust | |
London, United Kingdom |
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 |