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Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis

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: NCT02466243
Recruitment Status : Terminated (Sponsor terminated open-label extension.)
First Posted : June 9, 2015
Results First Posted : January 19, 2023
Last Update Posted : January 19, 2023
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Pennsylvania
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Dermatomyositis Drug: JBT-101 Drug: Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : January 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: JBT-101

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.

 Drug: JBT-101

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.

Other Name: lenabasum
Placebo Comparator: Placebo

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.

 Drug: Placebo

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Change in Patient-reported Outcomes From Baseline at 84 Days for Part A [ Time Frame: Part A: 84-day treatment period ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Part A):

  • 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).

Inclusion Criteria (Part B):

  • Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons

Exclusion Criteria (Part A and B):

  • 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:

    1. A positive pregnancy test (or at Visit 1);
    2. Hemoglobin < 10 g/dL;
    3. Neutrophils < 1.0 x 10^9/L;
    4. Platelets < 75 x 10^9/L;
    5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation;
    6. Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 x upper normal limit;
    7. 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.
Contacts and Locations
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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): NCT02466243


Locations
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United States, Pennsylvania
University of Pennsylvania Perlman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Corbus Pharmaceuticals Inc.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Pennsylvania
Investigators
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Principal Investigator: Victoria Werth, M.D. University of Pennsylvania Perlman School of Medicine
  Study Documents (Full-Text)

Documents provided by Corbus Pharmaceuticals Inc.:
Study Protocol  [PDF] January 3, 2020
Statistical Analysis Plan  [PDF] September 6, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02466243    
Other Study ID Numbers: JBT101-DM-001
116313 ( Registry Identifier: Investigation New Drug Application (IND) )
R21AR066286 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2015    Key Record Dates
Results First Posted: January 19, 2023
Last Update Posted: January 19, 2023
Last Verified: December 2022
Keywords provided by Corbus Pharmaceuticals Inc.:
JBT-101, lenabasum, dermatomyositis
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
 Lenabasum
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs