Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Corbus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Lenabasum 5 mg; Drug: Lenabasum 20 mg; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03451045

JBT101-CF-002

Details and patient eligibility

About

This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks.

Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.

Enrollment: 447 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 12 years of age at the time Informed Consent/ Assent is signed.
2. Weight ≥ 40 kg.
3. FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months.
4. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.

Exclusion criteria

1. Severe or unstable CF at screening or Visit 1.

2. Any of the following values for laboratory tests at screening:

   1. A positive pregnancy test.
   2. Hemoglobin < 10 g/dL in males and < 9 g/dL in females.
   3. Neutrophils < 1.0 x 10^9 /L.
   4. Platelets < 75 x 10^9/L.
   5. Creatinine clearance < 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
   6. Serum transaminases > 2.5 x upper limit of normal.

3. Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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447 participants in 3 patient groups, including a placebo group

Lenabasum 20 mg BID

Experimental group

Treatment:

Drug: Lenabasum 20 mg

Lenabasum 5 mg BID

Experimental group

Treatment:

Drug: Lenabasum 5 mg

Placebo BID

Placebo Comparator group

Treatment:

Other: Placebo