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Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

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ClinicalTrials.gov Identifier: NCT04410523
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

Condition or disease Intervention/treatment Phase
Asthma Drug: CSJ117 Drug: Placebo Phase 2

Detailed Description:
This study is a phase IIb, multicenter, multi-national, double-blind, randomized, parallel-arm, placebo-controlled study to evaluate the effect of 5 dose levels of CSJ117 (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard of care asthma therapy in adult subjects with inadequately controlled asthma despite medium to high dose ICS plus LABA. Approximately 625 patients will be randomized into this study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : November 23, 2023
Estimated Study Completion Date : February 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: CSJ117 0.5 mg
0.5 mg
 Drug: CSJ117

CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment
Experimental: CSJ117 1 mg
1 mg
 Drug: CSJ117

CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment
Experimental: CSJ117 2 mg
2 mg
 Drug: CSJ117

CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment
Experimental: CSJ117 4 mg
4 mg
 Drug: CSJ117

CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment
Experimental: CSJ117 8 mg
8 mg
 Drug: CSJ117

CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment
Placebo Comparator: Placebo
0 mg
 Drug: CSJ117

CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment


Drug: Placebo
Placebo inhaled once daily for 16 weeks. Delivered via Concept1 device


Outcome Measures
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Primary Outcome Measures :
  1. Pre-dose FEV1 change from baseline [ Time Frame: Baseline, Week 12 ]
    Average change from baseline in pre-dose FEV1 (Forced expiratory volume in 1 second) at Week 8 and Week 12.


Secondary Outcome Measures :
  1. FeNO change from baseline [ Time Frame: Baseline, Week 8 and Week 12 ]
    Average change from baseline in FeNO at Week 8 and Week 12.

  2. Anti-Drug immune response [ Time Frame: Baseline (Week 0) and Week 24 ]
    Measurement of Anti-Drug Antibodies (ADA) titers at baseline and during the study (Week 0 [Day 1] to Week 24)

  3. CSJ117 serum concentration [ Time Frame: Baseline (Week 0) and Week 24 ]
    Measurement of total CSJ117 serum concentration during the study (Week 0 [Day 1] to Week 24)

  4. Peak expiratory flow change from baseline [ Time Frame: Baseline, 12 weeks of treatment ]
    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. ACQ-5 change from baseline [ Time Frame: Baseline, Week 8 and Week 12 ]
    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. AQLQ+12 change from baseline [ Time Frame: Baseline, Week 8 and Week 12 ]
    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. Asthma symptom score change from baseline [ Time Frame: Baseline, Week 8 and Week 12 ]
    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 assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine').

  8. SABA use change from baseline [ Time Frame: Baseline and 12 weeks treatment ]
    Change from baseline in number of puffs of SABA (short-acting beta agonists) taken per day in each week (average over 7 days) during 12 weeks active-treatment period


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed asthma
  • Male and female patients aged ≥18 and ≤75 years
  • Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controllers
  • Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal
  • A positive reversibility test
  • ACQ-5 score of ≥ 1.5 at screening and end of run-in visits.

Exclusion Criteria:

  • Patients who have a cigarette smoking history of greater than 10 pack years or current smokers or vapers.
  • Pregnant or nursing (lactating) women
  • 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 one week after last study drug treatment
  • Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.
  • Patients who discontinued monoclonal antibodies (investigational or approved) for asthma due to lack of efficacy
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04410523


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04410523    
Other Study ID Numbers: CCSJ117A12201C
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
CSJ117, uncontrolled asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases