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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
Sponsor:
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE January 21, 2019
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE December 17, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
Efficacy of lenabasum compared to placebo as measured by Total Improvement Score (TIS) [ Time Frame: Week 52 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
  • Efficacy of lenabasum compared to placebo as measured by Mean MMT-8 Score [ Time Frame: Week 52 ]
  • Efficacy of lenabasum compared to placebo as measured by Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score [ Time Frame: Week 52 ]
  • Efficacy of lenabasum compared to placebo as measured by Investigator Global Assessment (IGA) scale of skin activity [ Time Frame: Week 52 ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
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 treatment with study drug is 52 weeks.
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 52 will be 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dermatomyositis
Intervention  ICMJE
  • Drug: Lenabasum 20 mg
    oral capsule
    Other Names:
    • JBT-101
    • anabasum
  • Drug: Lenabasum 5 mg
    oral capsule
    Other Names:
    • JBT-101
    • anabasum
  • Drug: Placebo
    oral capsule
Study Arms  ICMJE
  • Experimental: Lenabasum 20 mg
    Subjects will receive lenabasum 20 mg twice daily
    Intervention: Drug: Lenabasum 20 mg
  • Experimental: Lenabasum 5 mg
    Subjects will receive lenabasum 5 mg twice daily
    Intervention: Drug: Lenabasum 5 mg
  • Placebo Comparator: Placebo
    Subjects will receive placebo twice daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 11, 2020)
176
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2019)
150
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fulfill 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czechia,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Poland,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Switzerland
 
Administrative Information
NCT Number  ICMJE NCT03813160
Other Study ID Numbers  ICMJE JBT101-DM-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Corbus Pharmaceuticals Inc.
Study Sponsor  ICMJE Corbus Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Victoria P Werth, MD University of Pennsylvania
Principal Investigator: Chester V Oddis, MD University of Pittsburgh Department of Medicine/Division of Rheumatology
PRS Account Corbus Pharmaceuticals Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP