Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma
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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 is to determine if CJM112, an anti-IL-17A antibody, displays 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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Actual Study Start Date :
November 6, 2017
Estimated Primary Completion Date :
July 5, 2019
Estimated Study Completion Date :
July 5, 2019
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with a physician-diagnosed history of moderate to severe asthma for a period of at least one year prior to screening.
Patients on a stable therapy regimen of asthma for at least 3 months prior to screening with at least medium dose inhaled glucocorticoid and at least one additional asthma controller medication (such as inhaled long-acting bronchodilator, leukotriene antagonist, theophylline, stable low dose glucocorticoid, etc).
Acceptable and reproducible spirometry with FEV1 ≥ 40 and ≤ 90% of predicted at screening and baseline (re-testing is allowed once).
ACQ score ≥ 1.5 at screening and baseline (re-testing is allowed once).
Total serum IgE < 150 IU/mL
Peripheral blood eosinophils <300/μL
Previous use of biologics or other concomitant medications within the time periods specified in the SOM/protocol.
History of ongoing, chronic, or recurrent moderate or severe infectious disease.
Patients who have smoked or inhaled nicotine or tobacco products within the 6 month period prior to Visit 1 or who have a smoking history of greater than 10 pack years.
Patients who have had an asthma attack/exacerbation requiring systemic corticosteroids for at least 3 continuous days within 4 weeks prior to screening.
Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Visit 1 or during the screening period.
Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 13 weeks after stopping of investigational drug.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
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
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