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JBT-101

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |Corbus Pharmaceuticals Holdings, Inc.|Last Updated: Apr 4, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

JBT-101 · 1 trial · 1 indication

Phase 2 1
NCT02465450Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic FibrosisCystic Fibrosis
COMPLETED85 Analytics
PHASE2COMPLETED
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Adverse Events.
84 days of treatment

Secondary Endpoints

JBT-101 (Lenabasum) Plasma Concentrations on Day 84
Day 84
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JBT101 (lenabasum) 1 mgEXPERIMENTALJBT-101 1 mg once a day on Days 1-28
JBT-101 (lenabasum) 5 mgEXPERIMENTALJBT-101 5 mg once a day on Days 1-28
PlaceboPLACEBO_COMPARATORPlacebo once a day on Days 1-28.
JBT-101 (lenabasum) 20 mg QDEXPERIMENTALJBT-101 20 mg once a day on Days 29-84.
JBT-101 (lenabasum) 20 mg BIDEXPERIMENTALJBT-101 20 mg twice daily on Days 29-84.
Placebo BIDPLACEBO_COMPARATORPlacebo twice daily on Days 29-84.

Interventions

NameTypeDescription
JBT-101 (lenabasum)DRUGSubjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84.
PlaceboOTHERSubjects will receive placebo once a day on Days 1-28, placebo q pm on Days 29-84 (with JBT-101 20 mg q am), or placebo bid on Days 29-84.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria: 1. Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test; 2. Two well-characteri...

Countries:United StatesBelgiumFranceGermanyItalyPolandUnited Kingdom
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Frequently asked questions about JBT-101

What is JBT-101 used for in Cystic Fibrosis?

JBT-101 is an investigational small molecule being studied for the treatment of Cystic Fibrosis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety, tolerability, pharmacokinetics, and efficacy in patients with this condition.

Who makes JBT-101?

JBT-101 is being developed by Corbus Pharmaceuticals Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRBP. The company is conducting clinical trials to evaluate the drug's potential in treating Cystic Fibrosis.

What phase is JBT-101 in?

JBT-101 is in Phase 2 clinical development for Cystic Fibrosis. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and efficacy.

What clinical trials is JBT-101 in?

JBT-101 has been studied in one completed Phase 2 clinical trial with the identifier NCT02465450. This randomized, double-blind, placebo-controlled trial enrolled 85 participants aged 18 years and older with Cystic Fibrosis, and was conducted across multiple countries including the United States, Belgium, France, Germany, Italy, Poland, and the United Kingdom.

Is JBT-101 the same as Lenabasum?

Yes, JBT-101 is also known as Lenabasum. The Phase 2 clinical trial NCT02465450, which evaluated the drug in Cystic Fibrosis, is titled 'Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis,' confirming that both names refer to the same investigational drug.