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Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02465437
First Posted: June 8, 2015
Last Update Posted: October 23, 2017
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.
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.
  Purpose
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.

Condition Intervention Phase
Diffuse Cutaneous Systemic Sclerosis Drug: JBT-101 Drug: Placebo Drug: Part B Open-Label Extension Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic Sclerosis

Resource links provided by NLM:


Further study details as provided by Corbus Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Number of participants with treatment-emergent adverse events from baseline at Day 113 [ Time Frame: Part A: 112 days, with 84 day treatment and 28 day follow-up ]
  • Change in Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) from baseline at Day 85 [ Time Frame: Part A: 84 day treatment period ]
    CRISS responders and its domains of modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index

  • Number of participants with treatment-emergent adverse events from baseline at Day 394 [ Time Frame: Part B: 394 days, with 365 day treatment and 28 day follow-up ]
  • Change in Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) from baseline at Day 394 [ Time Frame: Part B: 365 day treatment period ]
    CRISS responders and its domains of modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index


Secondary Outcome Measures:
  • Change in patient-reported outcomes from baseline at Day 85 [ Time Frame: 84 day treatment period ]
    National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form, the PROMIS-29 Short Form single item pain numerical rating score, the 5-D Itch Score, and a Systemic Sclerosis Skin Questionnaire

  • Change in JBT-101 plasma concentrations from baseline at Day 85 [ Time Frame: 84 day treatment period ]
  • Change in metabolipidomic profile from baseline at Day 85 [ Time Frame: 84 day treatment period ]
  • Change in blood biomarkers of disease activity, inflammation and fibrosis from baseline at Day 85 [ Time Frame: 84 day treatment period ]
  • Change in skin biomarkers of inflammation and fibrosis from baseline at Day 85 [ Time Frame: 84 day treatment period ]

Enrollment: 42
Study Start Date: August 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JBT-101 5 mg/20 mg bid
JBT-101 5 mg q am and placebo q pm on Days 1-28, then JBT-101 20 mg twice a day (bid) on Days 29-84.
Drug: JBT-101
JBT-101 5 mg q am, 20 mg q am, or 20 mg bid on Days 1-28. JBT-101 20 mg bid on Days 29-84.
Drug: Placebo
Placebo q pm (with JBT-101 5 or 20 mg q AM) or placebo bid on Days 1-28. Placebo bid on Days 29-84.
Experimental: JBT-101 20 mg/20 mg bid
JBT-101 20 mg q am and placebo q pm on Days 1-28, then JBT-101 20 mg bid on Days 29-84.
Drug: JBT-101
JBT-101 5 mg q am, 20 mg q am, or 20 mg bid on Days 1-28. JBT-101 20 mg bid on Days 29-84.
Drug: Placebo
Placebo q pm (with JBT-101 5 or 20 mg q AM) or placebo bid on Days 1-28. Placebo bid on Days 29-84.
Experimental: JBT-101 20 mg bid/20 mg bid
JBT-101 20 mg bid on Days 1-84.
Drug: JBT-101
JBT-101 5 mg q am, 20 mg q am, or 20 mg bid on Days 1-28. JBT-101 20 mg bid on Days 29-84.
Placebo Comparator: Placebo
Placebo bid on Days 1-84.
Drug: Placebo
Placebo q pm (with JBT-101 5 or 20 mg q AM) or placebo bid on Days 1-28. Placebo bid on Days 29-84.
Experimental: Part B Open-label
JBT-101 20 mg bid on Days 1-364
Drug: Part B Open-Label Extension
JBT-101 20mg bid on Days 1-364

Detailed Description:

Part A of the study is an interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in subjects ≥ 18 and ≤ 70 years of age with active diffuse cutaneous systemic sclerosis. The screening period is up to 28 days, with 84 days treatment period and 28 days follow-up off active treatment.

Part B of the study is an interventional, open-label design will be used. All subjects who complete dosing in Part A without permanent discontinuation of study drug and who pass repeat safety screening will be eligible for enrollment. The screening period is up to 28 days, with a 364 day treatment period and 28 day follow up after last dose of JBT-101.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

Part A

  • Diffuse cutaneous systemic sclerosis
  • Have skin thickening from SSc in a body area suitable for repeat biopsy
  • Disease duration ≤ 3 years from the first non-Raynaud's phenomenon or >3 years and ≤ 6 years from the first non-Raynaud's phenomenon and high sensitivity C-reactive protein > 3 mg/L, high sensitivity interleukin-6 > 5 pg/mL, or increase in mRSS ≥ 5 points over the last 6 months with total RSS ≥ 12.
  • Stable treatment for SSc for at least 28 days before Visit 1

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):

  • Severe or unstable systemic sclerosis
  • Significant diseases or conditions other than systemic sclerosis 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. Serum transaminases > 2.0 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
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): NCT02465437


Locations
United States, California
Arthritis Association of Southern CA
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
United States, Maryland
John Hopkins Scleroderma Center
Baltimore, Maryland, United States
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States
United States, New Jersey
Rutgers University
New Brunswick, New Jersey, United States
United States, New York
Weill Cornell Medical College
New York, New York, United States
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
United States, Texas
University of Texas Houston Medical School
Houston, Texas, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Corbus Pharmaceuticals Inc.
Investigators
Principal Investigator: Robert Spiera, M.D. Weill Cornell Medical College, New York City, NY
  More Information

Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02465437     History of Changes
Other Study ID Numbers: JBT101-SSc-001
First Submitted: June 4, 2015
First Posted: June 8, 2015
Last Update Posted: October 23, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases