MedTrace Logo

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

NCT02465437 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-04-21

Study results available
· View outcomes & findings →

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.

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

Sponsors & Collaborators

  • Corbus Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Spiera, M.D. · Weill Cornell Medical College, New York City, NY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-10-31
Completion
2020-12-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465437 on ClinicalTrials.gov