NCT02465437 - Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

October 31, 2016

Study Completion Date

December 11, 2020

Conditions

Diffuse Cutaneous Systemic Sclerosis

Interventions

DRUG

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.

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.

DRUG

Part B Open-Label Extension

JBT-101 20mg bid on Days 1-364

Trial Locations (9)

Arthritis Association of Southern CA, Los Angeles

Stanford University, Palo Alto

John Hopkins Scleroderma Center, Baltimore

Boston University Medical Center, Boston

Rutgers University, New Brunswick

Weill Cornell Medical College, New York

University of Pittsburgh Medical Center, Pittsburgh

University of Texas Houston Medical School, Houston

University of Utah, Salt Lake City