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Los Angeles, California

  • Diffuse Cutaneous Systemic Sclerosis

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

JBT101-SSc-001


NCT ID:

NCT02465437


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Corbus Pharmaceuticals Inc.


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

42


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert Spiera, M.D.
Principal Investigator
Weill Cornell Medical College, New York City, NY

Study Dates

Start Date:August 2015
Completion Date:December 2021
Completion Type:Anticipated
Primary Completion Date:October 2016
Primary Completion Type:Actual
Verification Date:January 2019
Last Changed Date:January 11, 2019
First Received Date:June 4, 2015
First Results Date:March 8, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Participants With Treatment-emergent Adverse Events From Baseline at Day 113
Time Frame:Part A: Day 113
Safety Issues:False
Description:The overall number of subjects with TEAE's per treatment group during active dosing (Days 1-84) plus the 28 day follow-up.
Outcome Type:Primary Outcome
Measure:Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Day 85 and 113
Time Frame:Day 85 and Day 113
Safety Issues:False
Description:CRISS components included the following domains: modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index. An algorithm determines the
Outcome Type:Secondary Outcome
Measure:CRISS Individual Components (mRSS Total Score) Change From Baseline.
Time Frame:Day 85 and 113
Safety Issues:False
Description:The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for mRSS total score. Change from Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The mRSS consists of an evaluation of
Outcome Type:Secondary Outcome
Measure:CRISS Individual Component (FVC Percent Predicted) Change From Baseline
Time Frame:Day 85 and 113
Safety Issues:False
Description:The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for FVC percent predicted. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline.
Outcome Type:Secondary Outcome
Measure:CRISS Individual Component (Physician Global Assessment Score) Change From Baseline
Time Frame:Day 85 and 113
Safety Issues:False
Description:The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for physician global assessment. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The Physician Global Assessment of dise
Outcome Type:Secondary Outcome
Measure:CRISS Individual Component (Patient Global Assessment Score) Change From Baseline
Time Frame:Day 85 and 113
Safety Issues:False
Description:The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for patient global assessment. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The assessment at each specified visit wi
Outcome Type:Secondary Outcome
Measure:CRISS Individual Component (HAQ-DI Score) Change From Baseline.
Time Frame:Day 85 and 113
Safety Issues:False
Description:Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. Health Assessment Questionnaire - Disability Index includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are two

Study Interventions

Intervention Type:Drug
Name:JBT-101
Description: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.
Arm Name:JBT-101 5 mg/20 mg bid
Intervention Type:Drug
Name:Placebo
Description: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.
Arm Name:JBT-101 5 mg/20 mg bid
Intervention Type:Drug
Name:Part B Open-Label Extension
Description:JBT-101 20mg bid on Days 1-364
Arm Name:Part B Open-label

Study Arms

Study Arm Type:Experimental
Arm Name:JBT-101 5 mg/20 mg bid
Description: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.
Study Arm Type:Experimental
Arm Name:JBT-101 20 mg/20 mg bid
Description:JBT-101 20 mg q am and placebo q pm on Days 1-28, then JBT-101 20 mg bid on Days 29-84.
Study Arm Type:Experimental
Arm Name:JBT-101 20 mg bid/20 mg bid
Description:JBT-101 20 mg bid on Days 1-84.
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo bid on Days 1-84.
Study Arm Type:Experimental
Arm Name:Part B Open-label
Description:JBT-101 20 mg bid on Days 1-364

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Corbus Pharmaceuticals Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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