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Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT03451045
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE February 23, 2018
First Posted Date  ICMJE March 1, 2018
Last Update Posted Date July 29, 2019
Actual Study Start Date  ICMJE December 22, 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03451045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
  • Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo.
  • Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo.
  • Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo.
  • Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Event rate of PEx using the primary PEx definition with lenabasum 5 mg BID compared to placebo, during the treatment period.
  • Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Event rate of PEx using the secondary PEx definition with lenabasum 5 mg BID compared to placebo.
  • Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Time to first new PEx using the primary PEx definition with lenabasum 5 mg BID compared to placebo.
  • Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Time to first PEx using the secondary PEx definition with lenabasum 5 mg BID compared to placebo.
  • CFQ-R respiratory symptom domain [ Time Frame: Visit 1 through Week 28. ]
    Change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo.
  • FEV1 % predicted [ Time Frame: Visit 1 through Week 28. ]
    Change from baseline in FEV1 % predicted with lenabasum compared to placebo.
  • Adverse Events [ Time Frame: Visit 1 through Week 28. ]
    Incidence of treatment emergent adverse events with lenabasum treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • Drug: Lenabasum 20 mg
    Subjects will receive lenabasum 20 mg twice daily.
  • Drug: Lenabasum 5 mg
    Subjects will receive lenabasum 5 mg twice daily.
  • Other: Placebo
    Subjects will receive placebo twice daily.
Study Arms  ICMJE
  • Experimental: Lenabasum 20 mg BID
    Intervention: Drug: Lenabasum 20 mg
  • Experimental: Lenabasum 5 mg BID
    Intervention: Drug: Lenabasum 5 mg
  • Placebo Comparator: Placebo BID
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2018)
415
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lindsey Smith 617-977-5030 CFpatients@corbuspharma.com
Contact: Scott Constantine, MS 617-977-5030 CFpatients@corbuspharma.com
Listed Location Countries  ICMJE Austria,   Belgium,   Bulgaria,   Canada,   Czechia,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Poland,   Portugal,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03451045
Other Study ID Numbers  ICMJE JBT101-CF-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Corbus Pharmaceuticals Inc.
Study Sponsor  ICMJE Corbus Pharmaceuticals Inc.
Collaborators  ICMJE Cystic Fibrosis Foundation
Investigators  ICMJE
Principal Investigator: James Chmiel, MD Rainbow Baby and Children's Hospital
Principal Investigator: J. Stuart Elborn, MD National Heart and Lung Institute, Imperial College
PRS Account Corbus Pharmaceuticals Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP