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 (part of Novartis) · Phase 2, Interventional, and Treatment
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Among 105 studies in Asthma by Novartis — 3 open to participants now, 5 under way, 2 of them phase 3. Asthma · Novartis.
Among the 105 studies in Asthma by Novartis, this one is the 44th largest by enrollment of the 97 interventional ones that give a count, is one of 13 that started in 2017, is one of 43 in phase 2, and was the 88th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →3 of the 105 studies in Asthma by Novartis are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Argentina, France, Germany and 7 more countries
Ages 12–17
Novartis Pharmaceuticals · Sites in Argentina, Austria, Brazil and 14 more countries
Ages 6–11
Novartis Pharmaceuticals · Sites in Bulgaria, Colombia, Guatemala and 5 more countries
Ages 6–11
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
105 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 49 · Phase 3 33 · Phase 4 13
First in 2001; this study’s year is marked. 13 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 118 is above the median of 79 across 3,344 interventional studies indexed under Asthma.
Median enrollment 98 across the 97 interventional studies, 454 across the 8 observational. Of the 93 that completed or were terminated, 61 (66%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
3 of the studies in Asthma by Novartis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05274425Novartis PharmaceuticalsA 24-week rPMS Study in Real-world Setting for Enerzair | 2026-12-23 |
| NCT05217810Novartis PharmaceuticalsA 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura® | 2026-12-24 |
| NCT05222529Novartis PharmaceuticalsPharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma | 2027-07-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 105 studies in Asthma by Novartis, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
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:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
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
Ran from Nov 2017 to primary completion in Apr 2019, 17 months.
Results were first posted in Aug 2020, 1 year 3 months after primary completion. A results delay was requested in Feb 2020.
Of 137 industry-sponsored phase 2 interventional studies under Asthma, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 17 months is close to that.
Counting every sponsor, half of 199 studies reached it within 20 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CJM-112