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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diffuse Cutaneous Systemic Sclerosis

In brief

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.

Key facts

Study ID

NCT02465437

Run by

Corbus Pharmaceuticals Inc.

People needed

42

Starts

2015-08-01

Expected to finish

2020-12-11

Last updated by the study team

2021-04-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• A positive pregnancy test (or at Visit 1);
• Hemoglobin < 10 g/dL
• Neutrophils < 1.0 x 10\^9/L
• Platelets < 75 x 10\^9/L
• Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation
• Serum transaminases > 2.0 x upper normal limit
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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