Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02465450
• Date of registration: 04/06/2015
• Prospective Registration: Yes
• Primary sponsor: Corbus Pharmaceuticals Inc.
• Public title: Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
• Scientific title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis
• Date of first enrolment: September 29, 2015
• Target sample size: 85
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02465450
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, France, Germany, Italy, Poland, United Kingdom, United States

Contacts

• Name: J S Elborn, M.D.
• Affiliation: Queens University, Belfast, Northern Ireland, United Kingdom

• Name: James Chmiel, M.D.
• Affiliation: University Hospitals Cleveland Medical Center, Cleveland, OH

Key inclusion & exclusion criteria

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-characterized mutations in the CFTR gene

- FEV1 = 40% predicted corrected

- Stable treatment of CF for 14 days before Visit 1

Exclusion Criteria:

- Severe or unstable CF, such as:

1. Intravenous antibiotic treatment within 14 days before Visit 1

2. Treatment with any corticosteroids > 10 mg per day or > 20 mg every other day
oral prednisone or equivalent within 14 days before Visit 1

- Any one of the following values for laboratory tests at Screening:

1. A positive pregnancy test (or at Visit 1);

2. Hemoglobin < 10 g/dL

3. Neutrophils < 1.0 x 10~9/L

4. Platelets < 75 x 10~9/L

5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation

6. Serum transaminases > 2.5 x upper normal limit

7. Total bilirubin = 1.5 x upper limit of normal

- Any other condition that, in the opinion of the Principal Investigator, is clinically
significant and may put the subject at greater safety risk, influence response to
study product, or interfere with study assessments.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: JBT-101 (lenabasum)

Other: Placebo

Primary Outcome(s)

Number of Participants With Treatment Emergent Adverse Events. [Time Frame: 84 days of treatment]

Secondary Outcome(s)

JBT-101 (Lenabasum) Plasma Concentrations on Day 84 [Time Frame: Day 84]

Secondary ID(s)

JBT101-CF-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/02/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02465450