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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.

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.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080225330
Enrollment
625
Registered
2020-08-21
Start date
2020-09-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

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.

Sponsors

Novartis Pharma. K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnosed asthma Male and female patients aged >=18 and == 40% and == 1.5 at screening and end of run-in visits.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Asia except Japan, Europe, Japan, North America

Contacts

Public ContactHiroyuki Yamada

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026