A Bronchoprovocation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CSJ117 in Adult Subjects With Mild Atopic Asthma

Novartis

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo Comparator; Drug: CSJ117

Study type: Interventional

Funder types: Industry

Identifiers

NCT03138811

2016-004929-16 (EudraCT Number)

CCSJ117X2201

Details and patient eligibility

About

This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled, parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two parts, Cohort 2a and 2b

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of stable mild atopic asthma, as defined by the American Thoracic Society/ European Respiratory Society statement, who exhibit an early and late asthmatic response to a common inhaled allergen during the screening allergen inhalation challenge.
• Throughout the screening period and at baseline, only infrequent use of inhaled short-acting beta2-agonists (less than or equal to twice weekly) to treat asthma and/or prophylactic use prior to exercise. Inhaled short-acting beta2-agonist must be withheld for 8 hours before spirometry.

Exclusion criteria

• Hospitalization or emergency room treatment for acute asthma in the 6 months prior to screening or during the screening period.
• Any worsening or exacerbation of asthma (e.g., an event requiring a change in treatment) in the six weeks before screening or during the screening period.
• A history of any clinically significant chronic pulmonary disease other than mild atopic asthma, including but not limited to COPD, interstitial lung disease or bronchiectasis
• Use of immunosuppressive medications or allergen-specific immunotherapy within 6 months prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

CSJ117

Experimental group

Description:

low dose, medium dose, or high dose administered as a once daily inhaled dose

Treatment:

Drug: CSJ117

Placebo

Placebo Comparator group

Description:

placebo comparator administered as once daily inhaled dose

Treatment:

Drug: Placebo Comparator