Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03451045 |
Recruitment Status :
Completed
First Posted : March 1, 2018
Last Update Posted : March 26, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: Lenabasum 20 mg Drug: Lenabasum 5 mg Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 425 participants |
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 |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis |
Actual Study Start Date : | December 22, 2017 |
Actual Primary Completion Date : | June 17, 2020 |
Actual Study Completion Date : | June 17, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Lenabasum 20 mg BID |
Drug: Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily. |
Experimental: Lenabasum 5 mg BID |
Drug: Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily. |
Placebo Comparator: Placebo BID |
Other: Placebo
Subjects will receive placebo twice daily. |
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 12 years of age at the time Informed Consent/ Assent is signed.
- Weight ≥ 40 kg.
- FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months.
- 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:
- Severe or unstable CF at screening or Visit 1.
-
Any of the following values for laboratory tests at screening:
- A positive pregnancy test.
- Hemoglobin < 10 g/dL in males and < 9 g/dL in females.
- Neutrophils < 1.0 x 10^9 /L.
- Platelets < 75 x 10^9/L.
- Creatinine clearance < 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
- Serum transaminases > 2.5 x upper limit of normal.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451045

Principal Investigator: | James Chmiel, MD | Indiana University School of Medicine/Riley Physicians Pulmonary | |
Principal Investigator: | J. Stuart Elborn, MD | National Heart and Lung Institute, Imperial College |
Responsible Party: | Corbus Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT03451045 |
Other Study ID Numbers: |
JBT101-CF-002 |
First Posted: | March 1, 2018 Key Record Dates |
Last Update Posted: | March 26, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary exacerbation, lenabasum, JBT-101 |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |