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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 : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

Brief Summary:
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.

Condition or disease Intervention/treatment Phase
Dermatomyositis Drug: Lenabasum 20 mg Drug: Lenabasum 5 mg Drug: Placebo Phase 3

Detailed Description:
Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 28 will compare lenabasum 20 mg BID to placebo the Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints: Physician Global Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.

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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
Actual Primary Completion Date : March 31, 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:
  • JBT-101
  • anabasum

Experimental: Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily
Drug: Lenabasum 5 mg
oral capsule
Other Names:
  • JBT-101
  • anabasum

Placebo Comparator: Placebo
Subjects will receive placebo twice daily
Drug: Placebo
oral capsule




Primary Outcome Measures :
  1. Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS) [ Time Frame: Week 28 ]
    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.


Secondary Outcome Measures :
  1. Subjects who achieve Definition of Improvement (DOI) [ Time Frame: Week 28 ]
    Defined as ≥ 3 of 6 core set measures improved by ≥ 20% (relative to Baseline) with no more than 2 core set measures worsening by ≥ 25% (MMT-8 may not decrease by ≥ 25% from baseline)

  2. Subjects who improve by at least one category on the Investigator Global Assessment (IGA) scale of skin activity [ Time Frame: Week 28 ]
    The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.

  3. Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score [ Time Frame: Week 28 ]
    CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage (Klein et al, 2007; Yassaee et al, 2010) Disease Activity Score is rated using three activity measures. The activity score ranges from 0 to 100. Higher scores indicate greater disease severity.

  4. Subjects who achieve TIS >= 40 (at least moderate improvement) [ Time Frame: Week 28 ]
    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.

  5. TIS in subjects receiving immunosuppressive therapies (including corticosteroids) for > 1 year at Baseline [ 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.

  6. Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline. [ Time Frame: Week 28 ]
    ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted <80% at Screening or Visit 1

  7. Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline. [ Time Frame: Week 28 ]
    ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted <80% at Screening or Visit 1

  8. TIS at Visit 10 [ 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.

  9. TIS, lenabasum 5 mg BID versus placebo [ Time Frame: Week 28 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfill at least one of the following criteria for dermatomyositis:

    1. Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)
    2. ACR/EULAR criteria (Lundberg et al, 2017)
  • Disease activity/severity fulfills at least one of the following three criteria:

    1. MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale [VAS]) and MMT-8 score ≤ 142 (out of 150 total possible)
    2. Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each)
    3. MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of > 14
  • Stable doses of immunosuppressive medications for DM as defined by:

    1. Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1
    2. 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:

    1. A positive pregnancy test (or at Visit 1)
    2. Hemoglobin < 9 g/dL in males and < 8 g/dL in females
    3. Neutrophils < 1.0 × 10^9/L
    4. Platelets < 75 × 10^9/L
    5. 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

Information from the National Library of Medicine

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


Locations
Show Show 54 study locations
Sponsors and Collaborators
Corbus Pharmaceuticals Inc.
Investigators
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Principal Investigator: Victoria P Werth, MD University of Pennsylvania
Principal Investigator: Chester V Oddis, MD University of Pittsburgh Department of Medicine/Division of Rheumatology
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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: June 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corbus Pharmaceuticals Inc.:
dermatomyositis
cannabinoid receptor type 2 agonist
JBT-101
lenabasum
Additional relevant MeSH terms:
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Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases