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

NCT ID: NCT02465437

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2020-12-11

Brief Summary

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.

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.

Conditions

Diffuse Cutaneous Systemic Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

JBT-101

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

JBT-101

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

JBT-101 20 mg bid/20 mg bid

JBT-101 20 mg bid on Days 1-84.

Group Type: EXPERIMENTAL

JBT-101

Intervention Type: DRUG

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

Placebo bid on Days 1-84.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Part B Open-label

JBT-101 20 mg bid on Days 1-364

Group Type: EXPERIMENTAL

Part B Open-Label Extension

Intervention Type: DRUG

JBT-101 20mg bid on Days 1-364

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Part B Open-Label Extension

JBT-101 20mg bid on Days 1-364

Intervention Type: DRUG

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corbus Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Spiera, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medical College, New York City, NY

Locations

Arthritis Association of Southern CA

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

John Hopkins Scleroderma Center

Baltimore, Maryland, United States

Boston University Medical Center

Boston, Massachusetts, United States

Rutgers University

New Brunswick, New Jersey, United States

Weill Cornell Medical College

New York, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Texas Houston Medical School

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

JBT101-SSc-001

Identifier Type: -

Identifier Source: org_study_id