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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 : Active, not recruiting
First Posted : June 9, 2015
Last Update Posted : August 25, 2020
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Pennsylvania
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE June 2, 2015
First Posted Date  ICMJE June 9, 2015
Last Update Posted Date August 25, 2020
Study Start Date  ICMJE June 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
  • Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: Part A: 112-day treatment and follow-up period ]
  • Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) from baseline in Part A. [ Time Frame: Part A: 84-day treatment period ]
  • Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: Part B: (open-label extension) 364-day treatment and follow-up period ]
  • Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) from baseline in Part A. [ Time Frame: Part B: (open-label extension) 364-day treatment and follow-up period ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: 112-day treatment and follow-up period ]
  • Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) from baseline at 84 days [ Time Frame: 84-day treatment period ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • Change in patient-reported outcomes from baseline at 84 days for Part A [ Time Frame: Part A: 84-day treatment period ]
  • Change in patient-reported outcomes from baseline at 364 days for Part B [ Time Frame: Part B: 364-day treatment period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • Change in patient-reported outcomes from baseline at 84 days [ Time Frame: 84-day treatment period ]
    Patient Global Assessment, Skindex-29+3, PROMIS-29 Short Form
  • Change in blood biomarkers of inflammation and disease activity from baseline at 84 days [ Time Frame: 84-day treatment period ]
  • Change in skin biomarkers of inflammation from baseline at 84 days [ Time Frame: 84-days treatment ]
  • Change in plasma metabolipidomic profiles from baseline at 84 days [ Time Frame: 84-days treatment ]
  • Change in JBT-101 plasma concentrations from baseline through 84 days [ Time Frame: 84-days treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
Official Title  ICMJE A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dermatomyositis
Intervention  ICMJE
  • 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
  • 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.

Study Arms  ICMJE
  • 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.

    Intervention: Drug: JBT-101
  • 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.

    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: June 4, 2015)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02466243
Other Study ID Numbers  ICMJE JBT101-DM-001
116313 ( Registry Identifier: Investigation New Drug Application (IND) )
R21AR066286 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Corbus Pharmaceuticals Inc.
Study Sponsor  ICMJE Corbus Pharmaceuticals Inc.
Collaborators  ICMJE
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • University of Pennsylvania
Investigators  ICMJE
Principal Investigator: Victoria Werth, M.D. University of Pennsylvania Perlman School of Medicine
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