EUCTR2020-001762-11-GB
Active, not recruiting
Phase 1
An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Corbus Pharmaceuticals, Inc.
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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Completed
Not Applicable
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