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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: CSJ117

Study type: Interventional

Funder types: Industry

Identifiers

NCT04410523

2019-004905-29 (EudraCT Number)

CCSJ117A12201C

Details and patient eligibility

About

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.

Full 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).

Enrollment: 335 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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335 participants in 6 patient groups, including a placebo group

CSJ117 0.5mg

Experimental group

Description:

CSJ117 0.5 mg inhaled once daily

Treatment:

Drug: CSJ117

Drug: Placebo

CSJ117 1mg

Experimental group

Description:

CSJ117 1 mg inhaled once daily

Treatment:

Drug: CSJ117

Drug: Placebo

CSJ117 2mg

Experimental group

Description:

CSJ117 2 mg inhaled once daily

Treatment:

Drug: CSJ117

Drug: Placebo

CSJ117 4mg

Experimental group

Description:

CSJ117 4 mg inhaled once daily

Treatment:

Drug: CSJ117

Drug: Placebo

CSJ117 8mg

Experimental group

Description:

CSJ117 8 mg inhaled once daily

Treatment:

Drug: CSJ117

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo inhaled once daily

Treatment:

Drug: Placebo