Phase 3 RESOLVE-1 Study in Systemic Sclerosis
Double-blind, randomized, placebo-controlled, efficacy and safety study
Primary Endpoint in U.S.: ACR CRISS
Secondary Endpoints in U.S.: Change from baseline in HAQ-DI; Change from baseline in mRSS; Change from baseline in FVC % predicted
Key study inclusion criteria:*
- 18 years of age or older at the time Informed Consent is signed
- Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk)
- Disease duration less than or equal to 6 years from the first non-Raynaud's symptom
*There are additional criteria you must meet to be able to participate in this study.
Please note: People living with unstable diffuse cutaneous systemic sclerosis or diffuse cutaneous systemic sclerosis with end-stage organ involvement at Screening or Visit 1 cannot participate.
For Complete Study Details, Please View the Study Listing on clinicaltrials.gov: ClinicalTrials.gov Identifier: NCT03398837
Results from previous studies:
- The investigational drug lenabasum successfully achieved the primary objective of a Phase 2 study in 43 adults by demonstrating an acceptable safety and tolerability profile at all doses with no serious or severe adverse events related to the study drug. Lenabasum outperformed placebo in the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, reaching 33% at week 16, versus 0% for placebo. The most common adverse events were dizziness (22% vs 13% for lenabasum- vs. placebo-treated subjects) and fatigue (19% vs 7% for lenabasum- vs. placebo-treated subjects). To learn more about the study, click here.
- 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 to collect long term safety and efficacy data on lenabasum. In October 2018, Corbus reported that lenabasum demonstrated a clinically meaningful reduction in modified Rodnan skin score (mRSS) reaching -8.4 points at 6 months, -9.8 points at 12 months, and -10.7 points at 18 months, and an ACR CRISS of 65% at 6 months to 77% at 12 months, then 99% at 18 months. Lenabasum-related AEs occurring in more than 1 subject during chronic dosing was dizziness (n = 2, 6%). To learn more about the study, click:
Medical professionals may email us at SScphysicians@corbuspharma.com for more information about study participation.
Patients, caregivers or patient advocates looking for additional information may email us at SScpatients@corbuspharma.com.
For any other inquiries, please see our Contact Us page.