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
pa.clinicalresearch@gmail.com

Daniel Furst, MD

Stanford University

300 Pasteur Dr
Stanford, CA 94305
United States

Amanda Foster

650-721-7147
amfoster@stanford.edu

Lorinda Chung, MD

John Hopkins Scleroderma Center

5501 Hopkins Bayview Cir
Baltimore, MD 21224
United States

Gwen Leatherman

410-550-8582
gleathe@jhmi.edu

Laura Hummers

Boston University Medical Center

1 Boston Medical Center Pl
Boston, MA 2118
United States

Jessica Ziemek

617-638-5383
jziemek@bu.edu

Robert W Simms, MD

Rutgers University

125 Paterson St
New Brunswick, NJ 8901
United States

Deborah McCloskey

732-418-8478
mcclosda@rwjms.rutgers.edu

Vivien Hsu, MD

Weill Cornell Medical College

1300 York Ave
New York, NY 10065
United States

Christopher Hatzis

212-774-7194
hatzisc@hss.edu

Robert Spiera

University of Pittsburgh Medical Center

1515 Locust St
Pittsburgh, PA 15219
United States

Dana Ivanco

412-648-7040
des2@pitt.edu

Robyn T Domsic, MD

University of Utah

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

Jennifer Godina

801-581-4993
Jennifer.Godina@hsc.utah.edu

Tracy Frech, MD

University of Texas Houston Medical School

6431 Fannin, MSB 1150
Houston, Texas 77030

Patricia Gonzales

713-500-7118
patricia.gonzales@uth.tmc.edu

Maureen Mayes, MD

Study News