Status:
COMPLETED
Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 th...
Detailed Description
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: * 3...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 use highly effective methods of contraception during dosing and for 13 weeks after stopping of investigational drug.
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2019
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03299686
Start Date
November 6 2017
End Date
July 8 2019
Last Update
October 8 2021
Active Locations (29)
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1
Novartis Investigative Site
Fullerton, California, United States, 92835
2
Novartis Investigative Site
Riverside, California, United States, 92506
3
Novartis Investigative Site
Denver, Colorado, United States, 80206
4
Novartis Investigative Site
Boston, Massachusetts, United States, 02115