Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

NCT ID: NCT04410523

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2022-09-06

Brief Summary

The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

Detailed Description

This was a randomized, multicenter, multi-national, double-blind, placebo-controlled, parallel-arm study evaluating the effect of 5 dose levels of CSJ117 in adult subjects with inadequately controlled asthma despite medium to high dose inhaled corticosteroid (ICS) plus long-acting beta agonist (LABA).

Subjects were assigned to one of the following six treatment arms/groups in a ratio of 2:1:1:1:2:2:

• Placebo inhaled once daily
• CSJ117 0.5 mg inhaled once daily
• CSJ117 1.0 mg inhaled once daily
• CSJ117 2.0 mg inhaled once daily
• CSJ117 4.0 mg inhaled once daily
• CSJ117 8.0 mg inhaled once daily

The study included:

• A screening period of approximately 2 weeks
• A single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects experiencing an asthma exacerbation or respiratory tract infection during the run-in period)
• A double blinded treatment period of 12 weeks
• A follow-up period of up to 12 weeks, study drug free, following the last dose of study treatment.

Patients who successfully completed 12 weeks of treatment in this study could be offered participation in the Safety Extension Study CCSJ117A12201E1 (NCT04946318).

Conditions

Asthma

Study Design

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

Study Groups

CSJ117 0.5mg

CSJ117 0.5 mg inhaled once daily

Group Type: EXPERIMENTAL

CSJ117

Intervention Type: DRUG

CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment

Placebo

Intervention Type: DRUG

Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.

Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 1mg

CSJ117 1 mg inhaled once daily

Group Type: EXPERIMENTAL

CSJ117

Intervention Type: DRUG

CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment

Placebo

Intervention Type: DRUG

Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.

Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 2mg

CSJ117 2 mg inhaled once daily

Group Type: EXPERIMENTAL

CSJ117

Intervention Type: DRUG

CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment

Placebo

Intervention Type: DRUG

Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.

Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 4mg

CSJ117 4 mg inhaled once daily

Group Type: EXPERIMENTAL

CSJ117

Intervention Type: DRUG

CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment

Placebo

Intervention Type: DRUG

Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.

Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 8mg

CSJ117 8 mg inhaled once daily

Group Type: EXPERIMENTAL

CSJ117

Intervention Type: DRUG

CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment

Placebo

Intervention Type: DRUG

Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.

Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

Placebo

Placebo inhaled once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.

Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

Interventions

CSJ117

CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

CSJ117 = inhaled monoclonal antibody fragment

Intervention Type: DRUG

Placebo

Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.

Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosed asthma
• Male and female patients aged ≥18 and ≤75 years
• Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controllers
• Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal
• A positive reversibility test
• ACQ-5 score of ≥ 1.5 at screening and end of run-in visits.

Exclusion Criteria

• Patients who have a cigarette smoking history of greater than 10 pack years or current smokers
• Pregnant or nursing (lactating) women
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of contraception during dosing of study drug and until 12 weeks after last study drug treatment
• Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.

• 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

Bakersfield, California, United States

Novartis Investigative Site

Huntington Beach, California, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Mission Viejo, California, United States

Novartis Investigative Site

San Jose, California, United States

Novartis Investigative Site

Denver, Colorado, United States

Novartis Investigative Site

Marietta, Georgia, United States

Novartis Investigative Site

Bangor, Maine, United States

Novartis Investigative Site

White Marsh, Maryland, United States

Novartis Investigative Site

North Dartmouth, Massachusetts, United States

Novartis Investigative Site

Columbia, Missouri, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Omaha, Nebraska, United States

Novartis Investigative Site

Raleigh, North Carolina, United States

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Novartis Investigative Site

Pittsburgh, Pennsylvania, United States

Novartis Investigative Site

Greenville, South Carolina, United States

Novartis Investigative Site

Boerne, Texas, United States

Novartis Investigative Site

McKinney, Texas, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site

Ranelagh, Partido de Berazate, Buenos Aires, Argentina

Novartis Investigative Site

Concepción del Uruguay, Entre Ríos Province, Argentina

Novartis Investigative Site

San Salvador, Entre Ríos Province, Argentina

Novartis Investigative Site

Santa Fe, Rosario, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

Buenos Aires, , Argentina

Novartis Investigative Site

Buenos Aires, , Argentina

Novartis Investigative Site

Buenos Aires, , Argentina

Novartis Investigative Site

CABA, , Argentina

Novartis Investigative Site

Mendoza, , Argentina

Novartis Investigative Site

Paraná, , Argentina

Novartis Investigative Site

Erpent, , Belgium

Novartis Investigative Site

Liège, , Belgium

Novartis Investigative Site

Rousse, , Bulgaria

Novartis Investigative Site

Stara Zagora, , Bulgaria

Novartis Investigative Site

Ajax, Ontario, Canada

Novartis Investigative Site

Burlington, Ontario, Canada

Novartis Investigative Site

Etobicoke, Ontario, Canada

Novartis Investigative Site

Hamilton, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Trois-Rivières, Quebec, Canada

Novartis Investigative Site

Teplice, CZE, Czechia

Novartis Investigative Site

Jindřichův Hradec, , Czechia

Novartis Investigative Site

Lovosice, , Czechia

Novartis Investigative Site

Varnsdorf, , Czechia

Novartis Investigative Site

Peine, Lower Saxony, Germany

Novartis Investigative Site

Bamberg, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Darmstadt, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Hanover, , Germany

Novartis Investigative Site

Leipzig, , Germany

Novartis Investigative Site

Leipzig, , Germany

Novartis Investigative Site

Mainz, , Germany

Novartis Investigative Site

Potsdam, , Germany

Novartis Investigative Site

Witten, , Germany

Novartis Investigative Site

Guatemala City, GTM, Guatemala

Novartis Investigative Site

Guatemala City, GTM, Guatemala

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Balassagyarmat, , Hungary

Novartis Investigative Site

Gödöllő, , Hungary

Novartis Investigative Site

Komárom, , Hungary

Novartis Investigative Site

Pécs, , Hungary

Novartis Investigative Site

Szeged, , Hungary

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Osaka, Osaka, Japan

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Novartis Investigative Site

Kodaira, Tokyo, Japan

Novartis Investigative Site

Setagaya-Ku, Tokyo, Japan

Novartis Investigative Site

Setagaya-ku, Tokyo, Japan

Novartis Investigative Site

Toshima City, Tokyo, Japan

Novartis Investigative Site

Toshima Ku, Tokyo, Japan

Novartis Investigative Site

Osaka, , Japan

Novartis Investigative Site

Osaka, , Japan

Novartis Investigative Site

Riga, LV, Latvia

Novartis Investigative Site

Riga, LV, Latvia

Novartis Investigative Site

Daugavpils, , Latvia

Novartis Investigative Site

Daugavpils, , Latvia

Novartis Investigative Site

Riga, , Latvia

Novartis Investigative Site

Bulacan, , Philippines

Novartis Investigative Site

Iloilo City, , Philippines

Novartis Investigative Site

Manila, , Philippines

Novartis Investigative Site

Manila, , Philippines

Novartis Investigative Site

Bialystok, , Poland

Novartis Investigative Site

Krakow, , Poland

Novartis Investigative Site

Krakow, , Poland

Novartis Investigative Site

Lodz, , Poland

Novartis Investigative Site

Poznan, , Poland

Novartis Investigative Site

Poznan, , Poland

Novartis Investigative Site

Izhevsk, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Saratov, , Russia

Novartis Investigative Site

Ulyanovsk, , Russia

Novartis Investigative Site

Levice, , Slovakia

Novartis Investigative Site

Prešov, , Slovakia

Countries

United States; Argentina; Belgium; Bulgaria; Canada; Czechia; Germany; Guatemala; Hungary; Japan; Latvia; Philippines; Poland; Russia; 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=1568

Patient Lay Trial Summary

Other Identifiers

2019-004905-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCSJ117A12201C

Identifier Type: -

Identifier Source: org_study_id