A Phase 2 interventional study of Lenabasum 20 mg and Lenabasum 5 mg in Cystic Fibrosis, sponsored by Corbus Pharmaceuticals Inc.. Completed at 105 sites in 21 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Corbus Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment
Among 716 studies in Cystic Fibrosis with a site in United States — 85 open to participants now, 110 under way, 8 of them phase 3. Cystic Fibrosis · United States.
Among the 716 studies in Cystic Fibrosis with a site in United States, this one is the 22nd largest by enrollment of the 516 interventional ones, is one of 34 that started in 2017, is one of 103 in phase 2, and was the 450th registered.
1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.
This study's enrollment of 447 is above the median of 36 across 1,051 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →85 of the 716 studies in Cystic Fibrosis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 154 Cystic Fibrosis studies recruiting now, 95 (62%) set no upper age limit and 43 (28%) stop at 75 or younger; 84 take children under 18; 41 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →716 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 34 started in 2017.
Median enrollment 36 across the 516 interventional studies, 80 across the 193 observational. Of the 569 that completed or were terminated, 263 (46%) have results posted.
250 of 716 have an industry lead sponsor. The 10 most frequent:
Corbus Pharmaceuticals Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Corbus Pharmaceuticals Inc. has 2 studies filed under Cystic Fibrosis — fewer than ten, so there is no comparison to draw.
43 of the studies in Cystic Fibrosis with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06413368Phase 3Children's Hospital Los AngelesMaralixibat in Patients With Cystic Fibrosis and Constipation | 2027-06-30 |
| NCT06449677Phase 3Jaeb Center for Health ResearchBionic Pancreas in CFRD | 2027-06-30 |
| NCT06996951Phase 3Indiana UniversitySinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy | 2027-07 |
| NCT06237335ReCode TherapeuticsA Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF | 2026-11 |
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
Among the 716 studies in Cystic Fibrosis with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following values for laboratory tests at screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Lenabasum 20 mg
Drug: Lenabasum 5 mg
Other: Placebo
Subjects will receive lenabasum 20 mg twice daily.
Subjects will receive lenabasum 5 mg twice daily.
Subjects will receive placebo twice daily.
Pulmonary Exacerbation (PEx) Rate Over 28 Weeks
Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx.
Time frame: 28 weeks (Baseline Day 0 to Week 28)
Pulmonary Exacerbation (PEx) Rate
Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. The PEx rate is calculated as the number of PEx/28 weeks
Time frame: 28 weeks (Baseline Day 0 to Week 28)
Time to First New Pulmonary Exacerbation (PEx)
Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. The rate is calculate over a 28 week period from visit 1 to week 28 visit
Time frame: 28 weeks (Baseline Day 0 to Week 28)
Pulmonary Exacerbation (PEx)
Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx.
Time frame: 28 weeks (Baseline Day 0 to Week 28)
CFQ-R Respiratory Symptom Domain
Cystic Fibrosis Questionnaire - Revised measures change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo. Subjects \>/= 14 years of age. 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Time frame: 28 weeks (Change from Baseline Day 0 to Week 28)
FEV1 % Predicted
Change from baseline to week 28 in Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of a normal range. A lower percentage FEV1 is indicative of decrease in lung functionality. The changes observed from baseline to week 28 for lenabasum will be compared with those observed for placebo treated participants.
Time frame: 28 weeks (Change from Baseline Day 0 to Week 28)
| Milestone | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo |
|---|---|---|---|
| Started | 175 | 91 | 181 |
| Completed | 148 | 85 | 154 |
| Not completed | 27 | 6 | 27 |
| Withdrew: Lack of efficacy | 3 | 2 | 2 |
| Withdrew: Physician decision | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 4 | 0 | 5 |
| Withdrew: Pregnancy | 0 | 0 | 2 |
| Withdrew: Adverse event | 7 | 1 | 3 |
| Withdrew: Non-compliance with study | 2 | 0 | 1 |
| Withdrew: Any other reason | 10 | 2 | 13 |
Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx.
| events per participant/28 weeks | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo BID |
|---|---|---|---|
| Pulmonary Exacerbation (PEx) Rate Over 28 Weeks | 0.911 | 0.749 | 0.842 |
Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. The PEx rate is calculated as the number of PEx/28 weeks
| events per participant/28 weeks | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo |
|---|---|---|---|
| Pulmonary Exacerbation (PEx) Rate | 1.08 | 0.91 | 1.03 |
Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. The rate is calculate over a 28 week period from visit 1 to week 28 visit
| days | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo |
|---|---|---|---|
| Time to First New Pulmonary Exacerbation (PEx) | 162 (59 to 183) | 148 (58 to 183) | 143 (58 to 183) |
Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx.
| days | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo |
|---|---|---|---|
| Pulmonary Exacerbation (PEx) | 116 (38 to 183) | 113 (54 to 183) | 120 (49 to 183) |
Cystic Fibrosis Questionnaire - Revised measures change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo. Subjects \>/= 14 years of age. 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
| scores on a scale | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo |
|---|---|---|---|
| CFQ-R Respiratory Symptom Domain | 1.16 ± 1.41 | -2.92 ± 1.88 | -0.96 ± 1.41 |
Change from baseline to week 28 in Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of a normal range. A lower percentage FEV1 is indicative of decrease in lung functionality. The changes observed from baseline to week 28 for lenabasum will be compared with those observed for placebo treated participants.
| percentage of Predicted FEV1 | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo |
|---|---|---|---|
| FEV1 % Predicted | 0.014 ± 0.025 | -0.005 ± 0.033 | -0.012 ± 0.025 |
Collected over 28 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lenabasum 20 mg BID | 0/165 (0%) | 50/165 (30.3%) | 151/165 (91.5%) |
| Lenabasum 5 mg BID | 0/89 (0%) | 25/89 (28.1%) | 80/89 (89.9%) |
| Placebo | 0/171 (0%) | 50/171 (29.2%) | 151/171 (88.3%) |
| Event | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo |
|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosisRespiratory, thoracic and mediastinal disorders | 42/165 | 22/89 | 41/171 |
| Distal intestinal obstruction syndromeGastrointestinal disorders | 3/165 | 1/89 | 3/171 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 3/165 | 1/89 | 1/171 |
| InfluenzaInfections and infestations | 0/165 | 0/89 | 2/171 |
| Forced expiratory volume decreasedInvestigations | 1/165 | 0/89 | 2/171 |
| DehydrationMetabolism and nutrition disorders | 0/165 | 1/89 | 0/171 |
| HeadacheNervous system disorders | 0/165 | 1/89 | 0/171 |
| Renal colicRenal and urinary disorders | 0/165 | 1/89 | 0/171 |
| UreterolithiasisRenal and urinary disorders | 0/165 | 1/89 | 0/171 |
| TachcardiaCardiac disorders | 1/165 | 0/89 | 0/171 |
| Event | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo |
|---|---|---|---|
| Respiratory, thoracic and mediastinalRespiratory, thoracic and mediastinal disorders | 120/165 | 65/89 | 122/171 |
| Infections and infestationsInfections and infestations | 75/165 | 36/89 | 72/171 |
| Gastrointestinal disordersGastrointestinal disorders | 45/165 | 23/89 | 43/171 |
| Nervous systemNervous system disorders | 41/165 | 18/89 | 28/171 |
| General disorders and administration site conditionsGeneral disorders | 39/165 | 22/89 | 33/171 |
| InvestigationsInvestigations | 35/165 | 22/89 | 30/171 |
| Musculoskeletal and connective tissuesMusculoskeletal and connective tissue disorders | 17/165 | 14/89 | 18/171 |
| PsychiatricPsychiatric disorders | 11/165 | 10/89 | 11/171 |
| Skin and subcutaneousSkin and subcutaneous tissue disorders | 12/165 | 5/89 | 17/171 |
| Renal and urinaryRenal and urinary disorders | 1/165 | 5/89 | 8/171 |
modified intent to treat population
| Age, Continuous(years) | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo | Total |
|---|---|---|---|---|
| Mean | 26.2 ± 9.08 | 28.9 ± 11.24 | 26.6 ± 10.81 | 26.9 ± 10.5 |
| Sex: Female, Male(Participants) | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo | Total |
|---|---|---|---|---|
| Female | 91 | 44 | 93 | 228 |
| Male | 74 | 45 | 78 | 197 |
| Ethnicity (NIH/OMB)(Participants) | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 5 | 13 |
| Not Hispanic or Latino | 155 | 84 | 164 | 403 |
| Unknown or Not Reported | 5 | 2 | 2 | 9 |
| Race (NIH/OMB)(Participants) | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 3 | 5 |
| White | 161 | 86 | 163 | 410 |
| More than one race | 1 | 0 | 1 | 2 |
| Unknown or Not Reported | 2 | 1 | 3 | 6 |
| Body Mass Index(kg/m^2) | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo | Total |
|---|---|---|---|---|
| Mean | 21.07 ± 3.179 | 22.26 ± 4.164 | 21.52 ± 3.931 | 21.50 ± 3.728 |
| FEV1 (L)(liters) | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo | Total |
|---|---|---|---|---|
| Mean | 2.10 ± 0.73 | 2.20 ± 0.77 | 2.17 ± 0.75 | 2.15 ± 0.76 |
| Number of Acute Pulmonary Exacerbations in Past Year(Participants) | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo | Total |
|---|---|---|---|---|
| one | 1 | 0 | 1 | 2 |
| two | 75 | 43 | 76 | 194 |
| three | 63 | 30 | 69 | 162 |
| four | 20 | 11 | 13 | 44 |
| five | 6 | 4 | 10 | 20 |
| six or more | 0 | 1 | 2 | 3 |
| CFTR Genotype(Participants) | Lenabasum 20 mg BID | Lenabasum 5 mg BID | Placebo | Total |
|---|---|---|---|---|
| F508del/F508del | 83 | 34 | 74 | 191 |
| F508del/other | 56 | 38 | 70 | 164 |
| Other/other or unknown | 26 | 17 | 27 | 70 |
1 further baseline measures are reported on the registry.
Showing the first 100 of 105 sites across 21 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Dec 2017 to primary completion in Jun 2020, 29 months.
Results were first posted in Jan 2023, 2 years 7 months after primary completion.
Of 40 industry-sponsored phase 2 interventional studies under Cystic Fibrosis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 29 months is above that.
Counting every sponsor, half of 57 studies reached it within 21 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lenabasum
Corbus Pharmaceuticals Inc.