A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.
Phase 1
- Conditions
- Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune functionMedDRA version: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2020-001762-11-AT
- Lead Sponsor
- Corbus Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Consented subjects who completed, or discontinued from, a Corbus sponsored pivotal clinical study and do not enter an open-label extension (OLE) phase of a Corbus sponsored pivotal clinical trial study
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
1. Subjects who were randomized in a Corbus sponsored pivotal clinical study but did not receive at least one dose of study treatment (lenabasum or placebo).
2. Subjects who enroll in an OLE phase of a Corbus sponsored study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety of subjects who received at least one dose of study treatment (lenabasum or placebo) in a Corbus sponsored lenabasum pivotal clinical trial and do not enroll in an open-label extension (OLE) phase of a qualifying trial;Secondary Objective: Not applicable;Primary end point(s): As this trial is a safety surveillance study, there are no endpoints;Timepoint(s) of evaluation of this end point: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable