Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Description

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, Europe, and Australia. 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.

Study Start Date

December, 22 2017

Estimated Completion Date

November 2019

Interventions

  • Drug: Lenabasum 5 mg
  • Other: Placebo
  • Drug: Lenabasum 20 mg

Study ID

Corbus Pharmaceuticals Inc. -- JBT101-CF-002

Status

Recruiting

Trial ID

NCT03451045

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

415

Sponsor

Corbus Pharmaceuticals Inc.

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.

Gender

All

Ages

12 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
North Shore LIJ Health System - New Hyde Park, New York 39.6 miles Janis Wang MD 516-465-5427 None

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