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

NCT ID: NCT03299686

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-06
• Study Completion Date: 2019-07-08

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 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.

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:

• 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CJM112

Study treatment

Group Type: EXPERIMENTAL

CJM112

Intervention Type: DRUG

300 mg CJM112 (Study treatment) s.c. injection received per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment.

Placebo to CJM112

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo to CJM112

Intervention Type: OTHER

Placebo to match CJM112 + standard of care treatment

Interventions

CJM112

300 mg CJM112 (Study treatment) s.c. injection received per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment.

Intervention Type: DRUG

Placebo to CJM112

Placebo to match CJM112 + standard of care treatment

Intervention Type: OTHER

Eligibility Criteria

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 use highly effective methods of contraception during dosing and for 13 weeks after stopping of investigational drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Novartis Investigative Site

Jerusalem, , Israel

Novartis Investigative Site

Rehovot, , Israel

Novartis Investigative Site

Levice, , Slovakia

Novartis Investigative Site

Spišská Nová Ves, , Slovakia

Countries

United States; Argentina; Belgium; Denmark; France; Germany; Israel; Slovakia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=599

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

CCJM112X2204

Identifier Type: -

Identifier Source: org_study_id