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.

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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: CSJ117; Drug: Placebo

Detailed Description

This was a randomized, multicenter, multi-national, double-blind, placebo-controlled, parallel-arm study evaluating the effect of 5 dose levels of CSJ117 in adult subjects with inadequately controlled asthma despite medium to high dose inhaled corticosteroid (ICS) plus long-acting beta agonist (LABA).

Subjects were assigned to one of the following six treatment arms/groups in a ratio of 2:1:1:1:2:2:

• Placebo inhaled once daily
• CSJ117 0.5 mg inhaled once daily
• CSJ117 1.0 mg inhaled once daily
• CSJ117 2.0 mg inhaled once daily
• CSJ117 4.0 mg inhaled once daily
• CSJ117 8.0 mg inhaled once daily

The study included:

• A screening period of approximately 2 weeks
• A single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects experiencing an asthma exacerbation or respiratory tract infection during the run-in period)
• A double blinded treatment period of 12 weeks
• A follow-up period of up to 12 weeks, study drug free, following the last dose of study treatment.

Patients who successfully completed 12 weeks of treatment in this study could be offered participation in the Safety Extension Study CCSJ117A12201E1 (NCT04946318).

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABE
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1425FVH
    • Novartis Investigative Site
  • Buenos Aires, Argentina, 1900
    • Novartis Investigative Site
  • Caba, Argentina, C1430CAE
    • Novartis Investigative Site
  • Mendoza, Argentina, 5500
    • Novartis Investigative Site
  • Parana, Argentina, 3100
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1056ABJ
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1122AAK
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1425BEN
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1414AIF
      • Novartis Investigative Site
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Novartis Investigative Site
    • Ranelagh, Partido De Berazate, Buenos Aires, Argentina, 1884
      • Novartis Investigative Site
  • Entre Rios
    • San Salvador, Entre Rios, Argentina, E3218CHH
      • Novartis Investigative Site
  • Entre Ríos
    • Concepcion del Uruguay, Entre Ríos, Argentina, 3260
      • Novartis Investigative Site
  • Rosario
    • Santa Fe, Rosario, Argentina, S2000DBS
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DBS
      • Novartis Investigative Site
    • Rosario, Santa Fe, Argentina, S2000JKR
      • Novartis Investigative Site
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Novartis Investigative Site
    • San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
      • Novartis Investigative Site
• Belgium
  • Erpent, Belgium, 5100
    • Novartis Investigative Site
  • Liege, Belgium, 4000
    • Novartis Investigative Site
• Bulgaria
  • Ruse, Bulgaria, 7002
    • Novartis Investigative Site
  • Stara Zagora, Bulgaria, 6000
    • Novartis Investigative Site
• Canada
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Novartis Investigative Site
    • Burlington, Ontario, Canada, L7N 3V2
      • Novartis Investigative Site
    • Etobicoke, Ontario, Canada, M9V 4B4
      • Novartis Investigative Site
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H2V 2K1
      • Novartis Investigative Site
    • Trois Rivieres, Quebec, Canada, G8T 7A1
      • Novartis Investigative Site
• Czechia
  • Jindrichuv Hradec, Czechia, 377 01
    • Novartis Investigative Site
  • Lovosice, Czechia, 41002
    • Novartis Investigative Site
  • Varnsdorf, Czechia, 40747
    • Novartis Investigative Site
  • CZE
    • Teplice, CZE, Czechia, 415 01
      • Novartis Investigative Site
• Germany
  • Bamberg, Germany, 96049
    • Novartis Investigative Site
  • Berlin, Germany, 12203
    • Novartis Investigative Site
  • Berlin, Germany, 10717
    • Novartis Investigative Site
  • Berlin, Germany, 10969
    • Novartis Investigative Site
  • Berlin, Germany, 12159
    • Novartis Investigative Site
  • Berlin, Germany, 10119
    • Novartis Investigative Site
  • Darmstadt, Germany, 64283
    • Novartis Investigative Site
  • Frankfurt, Germany, 60596
    • Novartis Investigative Site
  • Hamburg, Germany, 20354
    • Novartis Investigative Site
  • Hamburg, Germany, 22299
    • Novartis Investigative Site
  • Hannover, Germany, 30173
    • Novartis Investigative Site
  • Leipzig, Germany, D-04299
    • Novartis Investigative Site
  • Leipzig, Germany, D-04347
    • Novartis Investigative Site
  • Mainz, Germany, 55128
    • Novartis Investigative Site
  • Potsdam, Germany, 14467
    • Novartis Investigative Site
  • Witten, Germany, 58452
    • Novartis Investigative Site
  • Niedersachsen
    • Peine, Niedersachsen, Germany, 31224
      • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01011
    • Novartis Investigative Site
  • GTM
    • Guatemala City, GTM, Guatemala, 01010
      • Novartis Investigative Site
    • Guatemala City, GTM, Guatemala, 01011
      • Novartis Investigative Site
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Novartis Investigative Site
  • Godollo, Hungary, 2100
    • Novartis Investigative Site
  • Komarom, Hungary, 2900
    • Novartis Investigative Site
  • Pecs, Hungary, 7635
    • Novartis Investigative Site
  • Szeged, Hungary, 6722
    • Novartis Investigative Site
• Japan
  • Osaka, Japan, 531-0073
    • Novartis Investigative Site
  • Osaka, Japan, 551-0032
    • Novartis Investigative Site
  • Kanagawa
    • Yokohama-city, Kanagawa, Japan, 223-0059
      • Novartis Investigative Site
  • Osaka
    • Osaka city, Osaka, Japan, 530 0001
      • Novartis Investigative Site
  • Tokyo
    • Chuo ku, Tokyo, Japan, 104-0031
      • Novartis Investigative Site
    • Chuo-ku, Tokyo, Japan, 103-0003
      • Novartis Investigative Site
    • Chuo-ku, Tokyo, Japan, 103-0028
      • Novartis Investigative Site
    • Kodaira, Tokyo, Japan, 187-0024
      • Novartis Investigative Site
    • Setagaya-Ku, Tokyo, Japan, 157-0072
      • Novartis Investigative Site
    • Setagaya-ku, Tokyo, Japan, 158-0097
      • Novartis Investigative Site
    • Toshima, Tokyo, Japan, 170-0003
      • Novartis Investigative Site
    • Toshima ku, Tokyo, Japan, 170 0003
      • Novartis Investigative Site
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Novartis Investigative Site
  • Daugavpils, Latvia, LV-5401
    • Novartis Investigative Site
  • Riga, Latvia, LV 1002
    • Novartis Investigative Site
  • LV
    • Riga, LV, Latvia, 1011
      • Novartis Investigative Site
    • Riga, LV, Latvia, 1038
      • Novartis Investigative Site
• Philippines
  • Bulacan, Philippines, 3020
    • Novartis Investigative Site
  • Iloilo, Philippines, 5000
    • Novartis Investigative Site
  • Iloilo City, Philippines, 5000
    • Novartis Investigative Site
  • Manila, Philippines, 1000
    • Novartis Investigative Site
  • Manila, Philippines, 1003
    • Novartis Investigative Site
• Poland
  • Bialystok, Poland, 15-044
    • Novartis Investigative Site
  • Krakow, Poland, 30033
    • Novartis Investigative Site
  • Krakow, Poland, 31-011
    • Novartis Investigative Site
  • Lodz, Poland, 90-153
    • Novartis Investigative Site
  • Poznan, Poland, 60-693
    • Novartis Investigative Site
  • Poznan, Poland, 60-823
    • Novartis Investigative Site
• Russian Federation
  • Izhevsk, Russian Federation, 426061
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 194354
    • Novartis Investigative Site
  • Saint-Petersburg, Russian Federation, 194354
    • Novartis Investigative Site
  • Saratov, Russian Federation, 410012
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 194354
    • Novartis Investigative Site
  • Ulyanovsk, Russian Federation, 432063
    • Novartis Investigative Site
• Slovakia
  • Levice, Slovakia, 93401
    • Novartis Investigative Site
  • Presov, Slovakia, 080 01
    • Novartis Investigative Site
• United States
  • California
    • Bakersfield, California, United States, 93301
      • Novartis Investigative Site
    • Huntington Beach, California, United States, 92647
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90025
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90048
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90017
      • Novartis Investigative Site
    • Mission Viejo, California, United States, 92691
      • Novartis Investigative Site
    • San Jose, California, United States, 95117
      • Novartis Investigative Site
  • Colorado
    • Denver, Colorado, United States, 80206
      • Novartis Investigative Site
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Novartis Investigative Site
  • Maine
    • Bangor, Maine, United States, 04401
      • Novartis Investigative Site
  • Maryland
    • White Marsh, Maryland, United States, 21162
      • Novartis Investigative Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747-3322
      • Novartis Investigative Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Novartis Investigative Site
    • Saint Louis, Missouri, United States, 63141
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Novartis Investigative Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Novartis Investigative Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Novartis Investigative Site
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Novartis Investigative Site
  • Texas
    • Boerne, Texas, United States, 78006
      • Novartis Investigative Site
    • McKinney, Texas, United States, 75069
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• 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 until 12 weeks after last study drug treatment
• Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo inhaled once daily	Drug: Placebo; Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period. Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
Experimental: CSJ117 0.5mg; CSJ117 0.5 mg inhaled once daily	Drug: CSJ117; CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device. CSJ117 = inhaled monoclonal antibody fragment; Drug: Placebo; Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period. Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
Experimental: CSJ117 1mg; CSJ117 1 mg inhaled once daily	Drug: CSJ117; CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device. CSJ117 = inhaled monoclonal antibody fragment; Drug: Placebo; Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period. Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
Experimental: CSJ117 2mg; CSJ117 2 mg inhaled once daily	Drug: CSJ117; CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device. CSJ117 = inhaled monoclonal antibody fragment; Drug: Placebo; Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period. Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
Experimental: CSJ117 4mg; CSJ117 4 mg inhaled once daily	Drug: CSJ117; CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device. CSJ117 = inhaled monoclonal antibody fragment; Drug: Placebo; Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period. Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
Experimental: CSJ117 8mg; CSJ117 8 mg inhaled once daily	Drug: CSJ117; CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device. CSJ117 = inhaled monoclonal antibody fragment; Drug: Placebo; Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period. Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12	FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. Pre-dose FEV1 is defined as average of the two FEV1 measurements taken at approximately 45 minutes and 15 minutes prior to dosing. The baseline pre-dose FEV1 value is defined as the average of the values taken approximately 2 hours 45 minutes and 2 hours 15 minutes prior to the first dose of double-blind treatment at Day 1. The least-squares means for change from baseline in pre-dose FEV1 averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A positive average change from baseline in pre-dose FEV1 is considered a favorable outcome.	Baseline, Weeks 8-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change From Baseline in FeNO at Week 8 and Week 12	Fractional exhaled Nitric Oxide (FeNO) pre-dose measurements were done at the investigational sites prior to spirometry assessments. FeNO is defined as the mean of two serial measurements. The measurement of exhaled nitric oxide is widely accepted as a non-invasive marker of airway inflammation (inflammation leads to elevation of FeNO). The baseline FeNO pre-dose measurements were taken at the end of the run-in period. The least-squares means for change from baseline in FeNO averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A negative average change from baseline in FeNO is considered a favorable outcome.	Baseline, Weeks 8-12
Change From Baseline in Morning PEF at Week 12	PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF. Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.	Baseline, Week 12
Change From Baseline in Evening PEF at Week 12	PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF. Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.	Baseline, Week 12
Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12	The Asthma Control Questionnaire-5 (ACQ-5) is a five-item, self-completed questionnaire, which is used as a measure of asthma symptom control. Patients were asked to recall how their asthma had 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 overall ACQ-5 score is the mean of all 5 questions, therefore between 0 (totally controlled) and 6 (severely uncontrolled). The baseline values of ACQ-5 were collected at the end of the run-in period. The least-squares means for change from baseline in ACQ-5 score averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM). A negative change from baseline in ACQ-5 is considered a favorable outcome.	Baseline, Weeks 8-12
Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12	The Asthma Quality of Life Questionnaire+12 (AQLQ+12) is a disease specific questionnaire, which is used as a measure of health-related quality of life. The AQLQ+12 comprises a total of 32 individual questions that span a total of 4 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 overall AQLQ+12 score is the mean of all 32 individual responses, therefore between 7 and 1 with higher scores indicating less impairment in health-related quality of life. The baseline values of AQLQ+12 were collected at the end of the run-in period. The least-squares means for change from baseline in AQLQ+12 score averaged between Week 8 and Week 12 visits were obtained from a linear mixed effects model for repeated measures (MMRM). A positive change from baseline is considered a favorable outcome.	Baseline, Weeks 8-12
Change From Baseline in ADSD Score at Week 8 and Week 12	Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity. Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking. Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms. Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period. A negative change from baseline is a favorable outcome.	Baseline, Week 8 and Week 12
Change From Baseline in ANSD Score at Week 8 and Week 12	Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity. Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking. Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms. Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period. A negative change from baseline is a favorable outcome.	Baseline, Week 8 and Week 12
Change From Baseline in Number of Puffs of SABA Taken Per Day at Week 12	Participants were given a short acting β2-agonist (SABA) such as salbutamol (100 µg) or albuterol (90 µg) to use as rescue medication throughout the study. Participants recorded in the eDiary, once in the morning and once in the evening, the use of rescue medication (number of puffs of SABA taken in the previous 12 hours). The total number of puffs of SABA taken per day was calculated and the mean daily use of puffs of SABA was derived by weekly intervals. The baseline value of number of puffs of SABA taken per day is the average of total daily SABA use during the run-in period. A negative change from baseline is considered a favorable outcome.	Baseline, Week 12
Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period	Number of participants with AEs and SAEs, including asthma exacerbations, changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs during the on-treatment period. The on-treatment period is between the date of first dose of double-blind study treatment and date of the last dose of randomized study treatment. Grades to characterize the severity of the adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE). For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The number of participants in each category is reported in the table.	From first dose of double-blind study treatment up to last dose (Week 12)
Number of Participants With Anti-CSJ117 Antibodies	Immunogenicity (antibody formation against CSJ117) was evaluated in serum by a validated bridging electrochemiluminescence immunoassay (ECLIA).	Day 1 and Weeks 2, 4, 8, 12, 14, 16, 20 and 24
CSJ117 Serum Concentration	CSJ117 concentration was determined in serum by a validated immunoassay method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero".	Day 1 and Week 12: pre-dose, 2 and 4 hours post-dose; Weeks 2, 4 and 8: pre-dose and 4 hours post-dose; Weeks 14, 16, 20 and 24: pre-dose

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Patient Lay Trial Summary

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: CSJ117; uncontrolled asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CCSJ117A12201C; 2019-004905-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No