A Phase 2 interventional study of CJM112 and Placebo to CJM112 in Asthma, sponsored by Novartis Pharmaceuticals. Completed at 29 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-08.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
An unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for T2-high(allergic/eosinophilic) asthma. The purpose of this study was to determine if CJM112, an anti-IL-17A antibody, displayed the clinical efficacy and safety profile to support further development in patients with inadequately controlled moderate to severe asthma with low IgE and low circulating eosinophil levels.
After an initial screening visit, run-in period and baseline assessments, the eligible subjects entered the treatment period and were randomized in a 3:2 ratio to one of the two treatment groups:
Exclusion Criteria:
Study treatment
Drug: CJM112
Placebo
Other: Placebo to CJM112
300 mg CJM112 (Study treatment) s.c. injection received per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment.
Placebo to match CJM112 + standard of care treatment
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
The primary efficacy analysis assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in Liters compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment.
Time frame: Baseline, Day 92
Change From Baseline in Forced Expiratory Volume 1 (FEV1) % of Predicted
The secondary efficacy analyses assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in % of predicted compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1% of predicted is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex and body composition. Pre-bronchodilator FEV1% of predicted was directly provided as part of the spirometry assessment.
Time frame: Baseline, Day 92
Change From Baseline in Asthma Control Questionnaire 6 (ACQ6) Score
The ACQ-6 is a validated asthma assessment tool that consists of 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale goes from 0 = 'totally controlled' to 6 = 'severely uncontrolled. Negative change from baseline values indicate improved asthma control.
Time frame: Baseline, Day 92
Change From Baseline in Asthma Control Questionnaire 7 (ACQ7) Score
The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.
Time frame: Baseline, Day 92
Percentage of Patients With at Least 0.5 Decrease in ACQ7 Score
The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function. An ACQ7 responder is defined as a patient with a decrease in score of greater or equal to 0.5 when compared to baseline.
Time frame: Baseline, Day 92
Percentage of Patients With Adverse Events (AEs) Leading to Discontinuation of Study Treatment
Number of patients with at least one adverse event leading to discontinuation of study treatment
Time frame: 85 days
Participants were from Argentina (2), Belgium (3), Germany (5), Denmark (4), France (2), Israel (3), Slovakia (2), The United States (7)
| Milestone | CJM112 300 mg | Placebo |
|---|---|---|
| Started | 70 | 48 |
| Pd (pharmacodynamics) analysis set | 69 | 48 |
| Completed | 59 | 44 |
| Not completed | 11 | 4 |
| Withdrew: Subject/guardian decision | 2 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Adverse event | 8 | 4 |
| Milestone | CJM112 300 mg | Placebo |
|---|---|---|
| Started | 59 | 44 |
| Completed | 59 | 43 |
| Not completed | 0 | 1 |
| Withdrew: Subject/guardian decision | 0 | 1 |
The primary efficacy analysis assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in Liters compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment.
| Liters | CJM112 300 mg | Placebo |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | 0.043 ± 0.031 | 0.016 ± 0.030 |
The secondary efficacy analyses assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in % of predicted compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1% of predicted is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex and body composition. Pre-bronchodilator FEV1% of predicted was directly provided as part of the spirometry assessment.
| Percent predicted | CJM112 300 mg | Placebo |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume 1 (FEV1) % of Predicted | 1.064 ± 0.914 | 0.151 ± 1.105 |
The ACQ-6 is a validated asthma assessment tool that consists of 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale goes from 0 = 'totally controlled' to 6 = 'severely uncontrolled. Negative change from baseline values indicate improved asthma control.
| units on scale | CJM112 300 mg | Placebo |
|---|---|---|
| Change From Baseline in Asthma Control Questionnaire 6 (ACQ6) Score | -0.93 ± 0.09 | -0.71 ± 0.11 |
The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.
| units on scale | CJM112 300 mg | Placebo |
|---|---|---|
| Change From Baseline in Asthma Control Questionnaire 7 (ACQ7) Score | -0.83 ± 0.08 | -0.60 ± 0.10 |
The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function. An ACQ7 responder is defined as a patient with a decrease in score of greater or equal to 0.5 when compared to baseline.
| Participants | CJM112 300 mg | Placebo |
|---|---|---|
| Percentage of Patients With at Least 0.5 Decrease in ACQ7 Score | 38 | 19 |
Number of patients with at least one adverse event leading to discontinuation of study treatment
| Participants | CJM112 300 mg | Placebo |
|---|---|---|
| Percentage of Patients With Adverse Events (AEs) Leading to Discontinuation of Study Treatment | 8 | 4 |
Collected over Adverse events were collected from first dose of study treatment until end of study treatment plus 91 days post treatment, up to maximum duration of 6 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CJM112 300 mg | 0/70 (0%) | 3/70 (4.3%) | 55/70 (78.6%) |
| Placebo | 0/48 (0%) | 2/48 (4.2%) | 38/48 (79.2%) |
| Event | CJM112 300 mg | Placebo |
|---|---|---|
| Stress cardiomyopathyCardiac disorders | 0/70 | 1/48 |
| PneumoniaInfections and infestations | 0/70 | 1/48 |
| AstheniaGeneral disorders | 1/70 | 0/48 |
| Urinary tract infectionInfections and infestations | 1/70 | 0/48 |
| DepressionPsychiatric disorders | 1/70 | 0/48 |
| Asthmatic crisisRespiratory, thoracic and mediastinal disorders | 1/70 | 0/48 |
| Event | CJM112 300 mg | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 16/70 | 13/48 |
| NasopharyngitisInfections and infestations | 16/70 | 6/48 |
| HeadacheNervous system disorders | 8/70 | 6/48 |
| Back painMusculoskeletal and connective tissue disorders | 3/70 | 5/48 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/70 | 4/48 |
| BronchitisInfections and infestations | 5/70 | 3/48 |
| DiarrhoeaGastrointestinal disorders | 3/70 | 3/48 |
| FatigueGeneral disorders | 4/70 | 3/48 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 3/70 | 3/48 |
| RashSkin and subcutaneous tissue disorders | 1/70 | 3/48 |
| Age, Continuous(Years) | CJM112 300 mg | Placebo | Total |
|---|---|---|---|
| Mean | 57.1 ± 12.79 | 55.9 ± 11.62 | 56.6 ± 12.29 |
| Sex: Female, Male(Participants) | CJM112 300 mg | Placebo | Total |
|---|---|---|---|
| Female | 39 | 32 | 71 |
| Male | 31 | 16 | 47 |
| Race/Ethnicity, Customized(Participants) | CJM112 300 mg | Placebo | Total |
|---|---|---|---|
| Asian | 2 | 0 | 2 |
| Black or African American | 6 | 1 | 7 |
| Other | 1 | 0 | 1 |
| White | 61 | 47 | 108 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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