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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

Clinical Trial Details

This is a research study of an investigational drug called JBT-101. The study is designed to see if JBT-101 is safe in people with scleroderma. It is also designed to see if the drug causes any changes in scleroderma skin biomarkers that reflect the level of disease activity.

A skin biopsy will allow us to observe the extent to which JBT-101 changes the skin compared to placebo treatment and show whether JBT-101 alters the expression of certain genes in the skin.

This research study is being done because currently there is no effective treatment for scleroderma.

The study will take place at the Hospital for Special Surgery, though your biopsies will be performed at the dermatology department of Weill Cornell Medicine.

Key Eligibility: 
  • Diagnosis of scleroderma
  • Detailed criteria will be reviewed with study team

Contact

Christopher Hatzis

Primary Investigator

Robert F. Spiera

Protocol ID(s)

Weill Cornell Medicine IRB #:

1506016292

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Study Type

Phase

2