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

• Status: Terminated
• Trial end date: 2020-12-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corbus Pharmaceuticals Inc.

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.