EUCTR2020-001762-11-HU
Active, not recruiting
Phase 1
An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials
ConditionsDermatomyositis (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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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 function
- 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
Similar Trials
Active, not recruiting
Phase 1
A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.EUCTR2020-001762-11-GBCorbus Pharmaceuticals, Inc.100
Active, not recruiting
Phase 1
A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.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 specifyEUCTR2020-001762-11-SECorbus Pharmaceuticals, Inc.100
Active, not recruiting
Phase 1
A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.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 specifyEUCTR2020-001762-11-DECorbus Pharmaceuticals, Inc.100
Active, not recruiting
Phase 1
A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.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 specifyEUCTR2020-001762-11-ATCorbus Pharmaceuticals, Inc.100
Completed
Not Applicable
Establishment of surveillance system for the longstanding ulcerative colitis patients Comparative study of efficacy for the targeted biopsy and the step biopsylcerative colitisJPRN-UMIN000001608Teikyo University School of Medicine200