Systemic Sclerosis

Ongoing Phase 2 Open-Label Diffuse Cutaneous Systemic Sclerosis (Scleroderma) Trial

Corbus Pharmaceuticals has completed a phase 2, double-blind, randomized, placebo-controlled multicenter study that evaluated the safety, tolerability, efficacy and pharmacokinetics of JBT-101 (also known as Anabasum) in patients with diffuse cutaneous systemic sclerosis. Results indicated a positive clinical benefit for patients who received Anabasum compared to placebo.

During the double-blind phase of the study participants were screened for up to 28 days to ensure they met study entry criteria. Following the initial screening, participants were provided a dose of Anabasum once a day for 28 days or either Anabasum or placebo twice a day for 84 days. On the 29th day, participants who were receiving once a day dosing transitioned to twice a day dosing for 56 days. The total treatment period was 84 days. After the treatment period, participants were followed for an additional 28 days.

  • Primary Endpoints: Change in CRISS Score, safety and tolerability
  • Secondary Endpoints: Quality of life, biomarkers of inflammation and fibrosis in blood and skin, metabolipidomic profile and pharmacokinetics
  • Study participants who completed the first portion of the study had the option of enrolling into an open-label extension to receive Anabasum twice a day. Eligibility:
    • Ages eligible for study: 18 years to 70 years
    • Genders eligible for study: both
  • Inclusion Criteria:
    • Completed dosing in the first portion of the study without permanent discontinuation of study product for safety or tolerability reasons or voluntary withdrawal from the study.

Anabasum (JBT-101) MOA in Systemic Sclerosis

Site Contact Principal Investigator

Arthritis Association of Southern California

800 W 6th St #1250
Los Angeles, CA 90017
United States

Lovelette Wilcock

609-895-0735 ext 133

Daniel Furst, MD

Stanford University

300 Pasteur Dr
Stanford, CA 94305
United States

Amanda Foster


Lorinda Chung, MD

John Hopkins Scleroderma Center

5501 Hopkins Bayview Cir
Baltimore, MD 21224
United States

Gwen Leatherman


Laura Hummers

Boston University Medical Center

1 Boston Medical Center Pl
Boston, MA 2118
United States

Jessica Ziemek


Robert W Simms, MD

Rutgers University

125 Paterson St
New Brunswick, NJ 8901
United States

Deborah McCloskey


Vivien Hsu, MD

Weill Cornell Medical College

1300 York Ave
New York, NY 10065
United States

Christopher Hatzis


Robert Spiera

University of Pittsburgh Medical Center

1515 Locust St
Pittsburgh, PA 15219
United States

Dana Ivanco


Robyn T Domsic, MD

University of Utah

50 N Medical Dr
Salt Lake City, UT 84132
United States

Jennifer Godina


Tracy Frech, MD

University of Texas Houston Medical School

6431 Fannin, MSB 1150
Houston, Texas 77030

Patricia Gonzales


Maureen Mayes, MD

Study News