Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Study Purpose

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. ≥ 18 years of age at the time Informed Consent is signed. 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk). 3. Disease duration ≤ 6 years from the first non-Raynaud's symptom. 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening. Key

Exclusion Criteria:

1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1. 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential; 2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females; 3. Neutrophils < 1.0 ×10^9/L; 4. Platelets < 75 ×10^9/L; 5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation; 6. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal. 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03398837
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Corbus Pharmaceuticals Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Robert Spiera, MDChris Denton, MD
Principal Investigator Affiliation	Professor of Clinical Medicine, Weill Cornell Medical CollegeProfessor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Canada, Germany, Israel, Japan, Korea, Republic of, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Diffuse Cutaneous Systemic Sclerosis

Contact a Trial Team

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University of California San Diego, La Jolla, California

Status

Recruiting

Address

University of California San Diego

La Jolla, California, 92037

Site Contact

Si Yin Chin

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