Phase 2 Open-Label Extension

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

Corbus received approval for an open-label extension to its double-blind, placebo-controlled, randomized Phase 2 clinical study of lenabasum for systemic sclerosis from the U.S. Food and Drug Administration (FDA) in April 2016. The open-label extension enables all the participants who completed the double-blind portion of the study the option of enrolling in an open-label extension to receive lenabasum twice a day for an additional 12 months. The goal of the open-label extension study is to collect long term safety and efficacy data on lenabasum.

6-Month Safety and Efficacy Data from Ongoing Open-Label Extension

Lenabasum demonstrated a significant and clinically meaningful reduction in mRSS reaching minus 8.4 (p < 0.0001 2-paired t-test) and an ACR CRISS of 71% at 28 weeks OLE. These responses exceeded those seen in the 12-week double-blind placebo-controlled dosing and increased at each visit with 33% of subjects achieving low mRSS scores (≤ 10 points) and 44% achieving a high ACR CRISS > 70%.


There were no severe or serious adverse events (AEs) and no clinically significant laboratory abnormalities related to the drug. Thirty (83%) subjects experienced adverse events (AEs) and only 3 (8%) subjects experienced AEs related to lenabasum during open-label dosing. The AEs experienced by ≥ 10% of subjects were upper respiratory tract illness in 7 (19%) subjects and urinary tract infection in 5 (14%) subjects.

Efficacy Outcomes

The modified Rodnan Skin Score (mRSS), the primary outcome for our Phase 3 RESOVLE-1 study of lenabasum in SSc, improved by a mean of -8.4 points (p < 0.0001) from baseline at the start of the Phase 2 double blind placebo controlled portion of the study. The baseline mRSS at study start was 24 points. 75% of subjects achieved a degree of improvement in mRSS (reduction ≥ 5 points and > 25% baseline) that has been associated with improved survival in SSc. A third of subjects reached a low mRSS ≤ 10 points.

The ACR Composite Response Index in diffuse cutaneous Systemic Sclerosis score (ACR CRISS) increased steadily with lenabasum treatment and reached 71% (median) from study start with 44% of subjects achieving a score > 70%. The magnitude of this change is more than double what has been observed in analyses of data from clinical studies with other therapeutics. Patient-reported disability, function, skin symptoms and global health all improved from study start and OLE start. Forced vital capacity (FVC) % predicted was stable during lenabasum treatment (mean change 0.3% predicted from study start) in contrast to the natural history of a decline in FVC in the disease.

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Site Contact Principal Investigator

Arthritis Association of Southern California

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

Ethan Zaccagnino

609-895-0735 ext 133

Daniel Furst, MD

Stanford University

300 Pasteur Dr
Stanford, CA 94305
United States

Joel Nicholus


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 02118
United States

Christopher Zammitti


Robert W Simms, MD

Rutgers University

125 Paterson St
New Brunswick, NJ 08901
United States

Deborah McCloskey


Vivien Hsu, MD

Weill Cornell Medical College

1300 York Ave
New York, NY 10065
United States

Emily Bakaj


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, TX 77030
United States

Patricia Gonzales


Maureen Mayes, MD