Loading clinical trials...
Loading clinical trials...
A Randomized, Subject- and Investigator-blinded, Placebo Controlled, Multi-center, Multiple Dose Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Moderate to Severe Asthma
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: * 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment. * Matching placebo + standard of care treatment. After completion of the last dose on Day 85 of treatment period, subjects returned for the final efficacy assessment on Day 92. Following the treatment period, all subjects entered a 13-week safety follow-up period, including the End of Study (EoS) visit on Day 176.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Fullerton, California, United States
Novartis Investigative Site
Riverside, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Raleigh, North Carolina, United States
Novartis Investigative Site
Medford, Oregon, United States
Novartis Investigative Site
Spartanburg, South Carolina, United States
Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina
Novartis Investigative Site
Santa Fe, Rosario, Argentina
Start Date
November 6, 2017
Primary Completion Date
April 8, 2019
Completion Date
July 8, 2019
Last Updated
October 8, 2021
118
ACTUAL participants
CJM112
DRUG
Placebo to CJM112
OTHER
Lead Sponsor
Novartis Pharmaceuticals
NCT07219173
NCT02327897
NCT07486401
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions