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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT03299686

Run by

Novartis Pharmaceuticals

People needed

118

Starts

2017-11-06

Expected to finish

2019-07-08

Last updated by the study team

2021-10-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Novartis Investigative Site — Jette, Brussels Capital, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Aalborg, Denmark
• Novartis Investigative Site — Copenhagen NV, Denmark
• Novartis Investigative Site — Hvidovre, Denmark
• Novartis Investigative Site — Odense C, Denmark
• Novartis Investigative Site — Montpellier, Herault, France
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Großhansdorf, Germany
• Novartis Investigative Site — Mainz, Germany
• Novartis Investigative Site — Wiesbaden, Germany
• Novartis Investigative Site — Jerusalem, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.