A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.

• Register: EUCTR
• Last refreshed on: 6 October 2020
• Main ID: EUCTR2020-001762-11-GB
• Date of registration: 23/07/2020
• Prospective Registration: Yes
• Primary sponsor: Corbus Pharmaceuticals, Inc.
• Public title: A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.
• Scientific title: An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials
• Date of first enrolment: 17/09/2020
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001762-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Non-interventional, observational clinical trial If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Regulatory Unit
• Affiliation: Accelsiors CRO and Consultancy Services Ltd

• Name: Regulatory Unit
• Affiliation: Accelsiors CRO and Consultancy Services Ltd

Key inclusion & exclusion 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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
MedDRA version: 20.0 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Therapeutic area: Not possible to specify

Intervention(s)

Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Not applicable

Primary end point(s): As this trial is a safety surveillance study, there are no endpoints

Secondary Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

2020-001762-11-HU

JBT101-LTS-001

Source(s) of Monetary Support

Corbus Pharmaceuticals, Inc.

Ethics review

Status: Not Approved
Approval date: 17/09/2020
Contact: