Study of efficacy and safety of CSJ117 in patients with severe uncontrolled asthma

A 12-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study to assess the efficacy and safety of CSJ117, when added to existing asthma therapy in patients =18 years of age with severe uncontrolled asthma. - CCSJ117A12201C

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004905-29-BE

Enrollment

625

Registered

2020-10-14

Start date

2020-12-07

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Code: CSJ117 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Not yet defined Current Sponsor code: CSJ117 Other descriptive name: CSJ117 Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed asthma 2. Male and female patients aged >18 and =65 years) yes F.1.3.1 Number of subjects for this age range 63

Exclusion criteria

Exclusion criteria: 1. Patients who have a cigarette smoking history of greater than 10 pack years or current smokers. 2. Pregnant or nursing (lactating) women 3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of contraception during dosing of study drug and 12 weeks after last study drug treatment (end of follow up) 4. Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV. 5. Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterize the dose-response relationship of five doses of CSJ117 inhaled daily on lung function, compared with placebo, at the end of the 12-week active-treatment period;Primary end point(s): Average change from baseline in pre-dose FEV1 (Forced expiratory volume in 1 second) at Week 8 and Week 12;Secondary Objective: 1. To characterize the dose-response relationship of five doses of CSJ117 inhaled daily on FeNO 2. To assess immunogenicity of five doses of CSJ117 3. To characterize the systemic pharmacokinetic (PK) profile of multiple inhaled daily doses of CSJ117 4. To characterize the efficacy of five doses of CSJ117 once daily on peak expiratory flow 5. To characterize the efficacy of five doses of CSJ117 once daily on ACQ-5 6. To characterize the efficacy of five doses of CSJ117 once daily on change from baseline in AQLQ score 7. To characterize the efficacy of five doses of CSJ117 once daily on daytime and nighttime asthma symptoms 8. To characterize the efficacy of five doses of CSJ117 once daily on daily short-acting ß-agonist (SABA) 9. To assess the safety of five doses of CSJ117 once daily with respect to adverse events (AE), electrocardiograms (ECGs), vital signs and laboratory tests ;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: To characterize the dose-response relationship of five doses of CSJ117 inhaled daily on lung function, compared with placebo, at the end of the 12-week active-treatment period;Primary end point(s): Average change from baseline in pre-dose FEV1 (Forced expiratory volume in 1 second) at Week 8 and Week 12;Secondary Objective: 1. To characterize the dose-response relationship of five doses of CSJ117 inhaled daily on FeNO 2. To assess immunogenicity of five doses of CSJ117 3. To characterize the systemic pharmacokinetic (PK) profile of multiple inhaled daily doses of CSJ117 4. To characterize the efficacy of five doses of CSJ117 once daily on peak expiratory flow 5. To characterize the efficacy of five doses of CSJ117 once daily on ACQ-5 6. To characterize the efficacy of five doses of CSJ117 once daily on change from baseline in AQLQ score 7. To characterize the efficacy of five doses of CSJ117 once daily on daytime and nighttime asthma symptoms 8. To characterize the efficacy of five doses of CSJ117 once daily on daily short-acting ß-agonist (SABA) 9. To assess the safety of five doses of CSJ117 once daily with respect to adverse events (AE), electrocardiograms (ECGs), vital signs and laboratory tests ;Timepoint(s) of evaluation of this end point: 12 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1. Average change from baseline in FeNO at Week 8 and Week 12. 2. Measurement of Anti-Drug Antibodies (ADA) titers at baseline and during the study (Week 0 [Day 1] to Week 24) 3. Measurement of total CSJ117 serum concentration during the study (Week 0 [Day 1] to Week 24) 4. Change from baseline in peak expiratory flow (PEF; am and pm), as assessed by mean morning and mean evening PEF in each week (average over 7 days) during 12 weeks of treatment 5. Average change from baseline in ACQ-5 score at Week 8 and Week 12. ACQ-5 (Asthma Control Questionnaire-5) consists of 5 items on symptom assessment. Patients will be asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). 6. Average change from baseline in AQLQ+12 score at Week 8 and Week 12 AQLQ+12 (Asthma Quality of Life Questionnaire) comprises a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health related quality of life. 7. Average change from baseline in asthma symptom score at week 8 and week 12. Asthma symptom score consists out of two parts i.e. ADSD (asthma daytime Symptom Diary) and ANSD (asthma nighttime symptom diary) integrated into one. Each part is comprised of 6 items assessing breathing symptoms, chest symptoms, and cough symptoms. All items are as	—

Measure

Time frame

Secondary end point(s): 1. Average change from baseline in FeNO at Week 8 and Week 12. 2. Measurement of Anti-Drug Antibodies (ADA) titers at baseline and during the study (Week 0 [Day 1] to Week 24) 3. Measurement of total CSJ117 serum concentration during the study (Week 0 [Day 1] to Week 24) 4. Change from baseline in peak expiratory flow (PEF; am and pm), as assessed by mean morning and mean evening PEF in each week (average over 7 days) during 12 weeks of treatment 5. Average change from baseline in ACQ-5 score at Week 8 and Week 12. ACQ-5 (Asthma Control Questionnaire-5) consists of 5 items on symptom assessment. Patients will be asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). 6. Average change from baseline in AQLQ+12 score at Week 8 and Week 12 AQLQ+12 (Asthma Quality of Life Questionnaire) comprises a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health related quality of life. 7. Average change from baseline in asthma symptom score at week 8 and week 12. Asthma symptom score consists out of two parts i.e. ADSD (asthma daytime Symptom Diary) and ANSD (asthma nighttime symptom diary) integrated into one. Each part is comprised of 6 items assessing breathing symptoms, chest symptoms, and cough symptoms. All items are as

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Countries

Argentina, Belgium, Bulgaria, Canada, Czechia, Czech Republic, France, Germany, Guatemala, Hungary, Italy, Japan, Korea, Republic of, Latvia, Philippines, Poland, Russian Federation, Slovakia, Spain, United States

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

clinical.enquiries@novartis.com+4161324 1111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026