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

An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001762-11-SE

Enrollment

100

Registered

2020-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 MedDRA version: 20.0 Level: PT Classification code 10012503 Term: Dermatomyositis System

Interventions

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, ajulemi

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

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

Public ContactRegulatory Unit

Accelsiors CRO and Consultancy Services Ltd

regulatory@accelsiors.com+361299 00 91

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026