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

NCT03299686 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CCJM112X2204
• Study Type: interventional
• Target: 118
• Locations: 8 countries
• Sites: 29

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.

Conditions

Asthma

Keywords

Asthma, allergic, eosinophilic, non-T2 high, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Expiratory Volume in One Second (FEV1)

  The primary efficacy analysis assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in Liters compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment.

  Baseline, Day 92

Secondary Outcomes (5)

• Change From Baseline in Forced Expiratory Volume 1 (FEV1) % of Predicted

  Baseline, Day 92

• Change From Baseline in Asthma Control Questionnaire 6 (ACQ6) Score

  Baseline, Day 92

• Change From Baseline in Asthma Control Questionnaire 7 (ACQ7) Score

  Baseline, Day 92

• Percentage of Patients With at Least 0.5 Decrease in ACQ7 Score

  Baseline, Day 92

• Percentage of Patients With Adverse Events (AEs) Leading to Discontinuation of Study Treatment

  85 days

Study Arms (2)

CJM112

EXPERIMENTAL

Study treatment

Drug: CJM112

Placebo to CJM112

PLACEBO COMPARATOR

Placebo

Other: Placebo to CJM112

Interventions

CJM112 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.

CJM112

Placebo to CJM112 OTHER

Placebo to match CJM112 + standard of care treatment

Placebo to CJM112

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (29)

Novartis Investigative Site

Fullerton, California, 92835, United States

Location

Novartis Investigative Site

Riverside, California, 92506, United States

Location

Novartis Investigative Site

Denver, Colorado, 80206, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02115, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63110, United States

Location

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Location

Novartis Investigative Site

Medford, Oregon, 97504, United States

Location

Novartis Investigative Site

Spartanburg, South Carolina, 29303, United States

Location

Novartis Investigative Site

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Novartis Investigative Site

Santa Fe, Rosario, S2000DBS, Argentina

Location

Novartis Investigative Site

Jette, Brussels Capital, 1090, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Aalborg, DK 9000, Denmark

Location

Novartis Investigative Site

Copenhagen NV, 2400, Denmark

Location

Novartis Investigative Site

Hvidovre, 2650, Denmark

Location

Novartis Investigative Site

Odense C, DK 5000, Denmark

Location

Novartis Investigative Site

Montpellier, Herault, 34059, France

Location

Novartis Investigative Site

Lyon, 69317, France

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Berlin, 12159, Germany

Location

Novartis Investigative Site

Großhansdorf, 22927, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Wiesbaden, 65187, Germany

Location

Novartis Investigative Site

Jerusalem, 91120, Israel

Location

Novartis Investigative Site

Jerusalem, Israel

Location

Novartis Investigative Site

Rehovot, 76100, Israel

Location

Novartis Investigative Site

Levice, 034 01, Slovakia

Location

Novartis Investigative Site

Spišská Nová Ves, 052 01, Slovakia

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Asthma; Dyspnea

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: October 3, 2017
• Study Start: November 6, 2017
• Primary Completion: April 8, 2019
• Study Completion: July 8, 2019
• Last Updated: October 8, 2021
• Results First Posted: August 6, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

US (8); DE (5); FR (2); BE (3); AR (2); DK (4); SL (2); IL (3)