Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:1/25/2019
Start Date:November 6, 2017
End Date:July 5, 2019
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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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 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.


Inclusion Criteria:

1. Patients with a physician-diagnosed history of moderate to severe asthma for a period
of at least one year prior to screening.

2. 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).

3. Acceptable and reproducible spirometry with FEV1 ≥ 40 and ≤ 90% of predicted at
screening and baseline (re-testing is allowed once).

4. ACQ score ≥ 1.5 at screening and baseline (re-testing is allowed once).

5. Total serum IgE < 150 IU/mL

6. Peripheral blood eosinophils <300/μL

Exclusion Criteria:

1. Previous use of biologics or other concomitant medications within the time periods
specified in the SOM/protocol.

2. History of ongoing, chronic, or recurrent moderate or severe infectious disease.

3. 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.

4. Patients who have had an asthma attack/exacerbation requiring systemic corticosteroids
for at least 3 continuous days within 4 weeks prior to screening.

5. Patients who have had a respiratory tract infection or asthma worsening within 4 weeks
prior to Visit 1 or during the screening period.

6. 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.
We found this trial at
11
sites
New Brunswick, New Jersey 08901
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Boston, Massachusetts 02118
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Boston, MA
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Caba, Buenos Aires
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Caba,
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Denver, Colorado 80262
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Fullerton, California 92835
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Fullerton, CA
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Medford, Oregon 97504
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Medford, OR
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Raleigh, North Carolina 27609
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Riverside, California 92506
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Riverside, CA
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Saint Louis, Missouri 63128
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Saint Louis, MO
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Spartanburg, South Carolina 29302
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Tampa, Florida 33613
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Tampa, FL
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