Study Stopped
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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.
2 other identifiers
interventional
335
15 countries
113
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Sep 2020
Typical duration for phase_2 asthma
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedStudy Start
First participant enrolled
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2022
CompletedResults Posted
Study results publicly available
August 7, 2023
CompletedJune 20, 2024
June 1, 2024
1.8 years
May 6, 2020
July 18, 2023
June 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Average Change From Baseline in FeNO at Week 8 and Week 12
Baseline, Weeks 8-12
Change From Baseline in Morning PEF at Week 12
Baseline, Week 12
Change From Baseline in Evening PEF at Week 12
Baseline, Week 12
Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12
Baseline, Weeks 8-12
Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12
Baseline, Weeks 8-12
- +6 more secondary outcomes
Study Arms (6)
CSJ117 0.5mg
EXPERIMENTALCSJ117 0.5 mg inhaled once daily
CSJ117 1mg
EXPERIMENTALCSJ117 1 mg inhaled once daily
CSJ117 2mg
EXPERIMENTALCSJ117 2 mg inhaled once daily
CSJ117 4mg
EXPERIMENTALCSJ117 4 mg inhaled once daily
CSJ117 8mg
EXPERIMENTALCSJ117 8 mg inhaled once daily
Placebo
PLACEBO COMPARATORPlacebo inhaled once daily
Interventions
CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device. CSJ117 = inhaled monoclonal antibody fragment
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (113)
Novartis Investigative Site
Bakersfield, California, 93301, United States
Novartis Investigative Site
Huntington Beach, California, 92647, United States
Novartis Investigative Site
Los Angeles, California, 90017, United States
Novartis Investigative Site
Los Angeles, California, 90025, United States
Novartis Investigative Site
Los Angeles, California, 90048, United States
Novartis Investigative Site
Mission Viejo, California, 92691, United States
Novartis Investigative Site
San Jose, California, 95117, United States
Novartis Investigative Site
Denver, Colorado, 80206, United States
Novartis Investigative Site
Marietta, Georgia, 30060, United States
Novartis Investigative Site
Bangor, Maine, 04401, United States
Novartis Investigative Site
White Marsh, Maryland, 21162, United States
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747-3322, United States
Novartis Investigative Site
Columbia, Missouri, 65203, United States
Novartis Investigative Site
St Louis, Missouri, 63141, United States
Novartis Investigative Site
Omaha, Nebraska, 68134, United States
Novartis Investigative Site
Raleigh, North Carolina, 27607, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73120, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15241, United States
Novartis Investigative Site
Greenville, South Carolina, 29607, United States
Novartis Investigative Site
Boerne, Texas, 78006, United States
Novartis Investigative Site
McKinney, Texas, 75069, United States
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1122AAK, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1414AIF, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1425BEN, Argentina
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600, Argentina
Novartis Investigative Site
Ranelagh, Partido de Berazate, Buenos Aires, 1884, Argentina
Novartis Investigative Site
Concepción del Uruguay, Entre Ríos Province, 3260, Argentina
Novartis Investigative Site
San Salvador, Entre Ríos Province, E3218CHH, Argentina
Novartis Investigative Site
Santa Fe, Rosario, S2000DBS, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000JKR, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina
Novartis Investigative Site
Buenos Aires, 1900, Argentina
Novartis Investigative Site
Buenos Aires, C1125ABE, Argentina
Novartis Investigative Site
Buenos Aires, C1425FVH, Argentina
Novartis Investigative Site
CABA, C1430CAE, Argentina
Novartis Investigative Site
Mendoza, 5500, Argentina
Novartis Investigative Site
Paraná, 3100, Argentina
Novartis Investigative Site
Erpent, 5100, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Rousse, 7002, Bulgaria
Novartis Investigative Site
Stara Zagora, 6000, Bulgaria
Novartis Investigative Site
Ajax, Ontario, L1S 2J5, Canada
Novartis Investigative Site
Burlington, Ontario, L7N 3V2, Canada
Novartis Investigative Site
Etobicoke, Ontario, M9V 4B4, Canada
Novartis Investigative Site
Hamilton, Ontario, L8N 3Z5, Canada
Novartis Investigative Site
Montreal, Quebec, H2V 2K1, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, G8T 7A1, Canada
Novartis Investigative Site
Teplice, CZE, 415 01, Czechia
Novartis Investigative Site
Jindřichův Hradec, 377 01, Czechia
Novartis Investigative Site
Lovosice, 41002, Czechia
Novartis Investigative Site
Varnsdorf, 40747, Czechia
Novartis Investigative Site
Peine, Lower Saxony, 31224, Germany
Novartis Investigative Site
Bamberg, 96049, Germany
Novartis Investigative Site
Berlin, 10119, Germany
Novartis Investigative Site
Berlin, 10717, Germany
Novartis Investigative Site
Berlin, 10969, Germany
Novartis Investigative Site
Berlin, 12159, Germany
Novartis Investigative Site
Berlin, 12203, Germany
Novartis Investigative Site
Darmstadt, 64283, Germany
Novartis Investigative Site
Frankfurt, 60596, Germany
Novartis Investigative Site
Hamburg, 20354, Germany
Novartis Investigative Site
Hamburg, 22299, Germany
Novartis Investigative Site
Hanover, 30173, Germany
Novartis Investigative Site
Leipzig, D-04299, Germany
Novartis Investigative Site
Leipzig, D-04347, Germany
Novartis Investigative Site
Mainz, 55128, Germany
Novartis Investigative Site
Potsdam, 14467, Germany
Novartis Investigative Site
Witten, 58452, Germany
Novartis Investigative Site
Guatemala City, GTM, 01010, Guatemala
Novartis Investigative Site
Guatemala City, GTM, 01011, Guatemala
Novartis Investigative Site
Guatemala City, 01010, Guatemala
Novartis Investigative Site
Guatemala City, 01011, Guatemala
Novartis Investigative Site
Balassagyarmat, 2660, Hungary
Novartis Investigative Site
Gödöllő, 2100, Hungary
Novartis Investigative Site
Komárom, 2900, Hungary
Novartis Investigative Site
Pécs, 7635, Hungary
Novartis Investigative Site
Szeged, 6722, Hungary
Novartis Investigative Site
Yokohama, Kanagawa, 223-0059, Japan
Novartis Investigative Site
Osaka, Osaka, 530 0001, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, 104-0031, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0003, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0028, Japan
Novartis Investigative Site
Kodaira, Tokyo, 187-0024, Japan
Novartis Investigative Site
Setagaya-Ku, Tokyo, 157-0072, Japan
Novartis Investigative Site
Setagaya-ku, Tokyo, 158-0097, Japan
Novartis Investigative Site
Toshima City, Tokyo, 170-0003, Japan
Novartis Investigative Site
Toshima Ku, Tokyo, 170 0003, Japan
Novartis Investigative Site
Osaka, 531-0073, Japan
Novartis Investigative Site
Osaka, 551-0032, Japan
Novartis Investigative Site
Riga, LV, 1011, Latvia
Novartis Investigative Site
Riga, LV, 1038, Latvia
Novartis Investigative Site
Daugavpils, LV-5401, Latvia
Novartis Investigative Site
Daugavpils, LV-5417, Latvia
Novartis Investigative Site
Riga, LV 1002, Latvia
Novartis Investigative Site
Bulacan, 3020, Philippines
Novartis Investigative Site
Iloilo City, 5000, Philippines
Novartis Investigative Site
Manila, 1000, Philippines
Novartis Investigative Site
Manila, 1003, Philippines
Novartis Investigative Site
Bialystok, 15-044, Poland
Novartis Investigative Site
Krakow, 30033, Poland
Novartis Investigative Site
Krakow, 31-011, Poland
Novartis Investigative Site
Lodz, 90-153, Poland
Novartis Investigative Site
Poznan, 60-693, Poland
Novartis Investigative Site
Poznan, 60-823, Poland
Novartis Investigative Site
Izhevsk, 426061, Russia
Novartis Investigative Site
Saint Petersburg, 194354, Russia
Novartis Investigative Site
Saratov, 410012, Russia
Novartis Investigative Site
Ulyanovsk, 432063, Russia
Novartis Investigative Site
Levice, 93401, Slovakia
Novartis Investigative Site
Prešov, 080 01, Slovakia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2020
First Posted
June 1, 2020
Study Start
September 9, 2020
Primary Completion
July 12, 2022
Study Completion
September 6, 2022
Last Updated
June 20, 2024
Results First Posted
August 7, 2023
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
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.