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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299686
• Other study ID #: CCJM112X2204
• Status: Completed
• Phase: Phase 2
• Start date: November 6, 2017
• Est. completion date: July 8, 2019

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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.

Other:
• Placebo to CJM112
Placebo to match CJM112 + standard of care treatment

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Santa Fe	Rosario
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Jette	Brussel
Belgium	Novartis Investigative Site	Liege
Denmark	Novartis Investigative Site	Aalborg
Denmark	Novartis Investigative Site	Copenhagen NV
Denmark	Novartis Investigative Site	Hvidovre
Denmark	Novartis Investigative Site	Odense C
France	Novartis Investigative Site	Lyon Cedex 04
France	Novartis Investigative Site	Montpellier cedex 5	Herault
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Grosshansdorf
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Wiesbaden
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Rehovot
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Spisska Nova Ves
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Riverside	California
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Forced Expiratory Volume 1 (FEV1) % of Predicted	The secondary efficacy analyses assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in % of predicted compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1% of predicted is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex and body composition. Pre-bronchodilator FEV1% of predicted was directly provided as part of the spirometry assessment.	Baseline, Day 92
Secondary	Change From Baseline in Asthma Control Questionnaire 6 (ACQ6) Score	The ACQ-6 is a validated asthma assessment tool that consists of 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale goes from 0 = 'totally controlled' to 6 = 'severely uncontrolled.; Negative change from baseline values indicate improved asthma control.	Baseline, Day 92
Secondary	Change From Baseline in Asthma Control Questionnaire 7 (ACQ7) Score	The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.	Baseline, Day 92
Secondary	Percentage of Patients With at Least 0.5 Decrease in ACQ7 Score	The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.; An ACQ7 responder is defined as a patient with a decrease in score of greater or equal to 0.5 when compared to baseline.	Baseline, Day 92
Secondary	Percentage of Patients With Adverse Events (AEs) Leading to Discontinuation of Study Treatment	Number of patients with at least one adverse event leading to discontinuation of study treatment	85 days

External Links

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