A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients => 18 Years of Age With Severe Uncontrolled Asthma.

JRCT ID: jRCT2080225330

Registered date:21/08/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Asthma
• Date of first enrollment: 25/09/2020
• Target sample size: 625
• Countries of recruitment: Japan,Asia except Japan,North America,Europe
• Study type: Interventional

Intervention(s)

CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.
Placebo inhaled once daily for 16 weeks. Delivered via Concept1 device.

Outcome(s)

Primary Outcome

Pre-dose FEV1 change from baseline (Time Frame: Baseline, Week 12)
Average change from baseline in pre-dose FEV1 (Forced expiratory volume in 1 second) at Week 8 and Week 12.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude criteria

Patients who have a cigarette smoking history of greater than 10 pack years or current smokers or vapers.
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 one week after last study drug treatment
Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.
Patients who discontinued monoclonal antibodies (investigational or approved) for asthma due to lack of efficacy

Related Information

• Primary Sponsor: Novartis Pharma. K.K.
• Secondary ID(s): NCT04410523,JapicCTI-205426