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

NCT ID: NCT03138811

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-18
• Study Completion Date: 2019-07-16

Brief Summary

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

Conditions

Asthma

Study Design

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

Study Groups

CSJ117

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

Group Type: EXPERIMENTAL

CSJ117

Intervention Type: DRUG

inhaled once daily dose

Placebo

placebo comparator administered as once daily inhaled dose

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: DRUG

inhaled once daily dose

Interventions

CSJ117

inhaled once daily dose

Intervention Type: DRUG

Placebo Comparator

inhaled once daily dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Edmonton, Alberta, Canada

Novartis Investigative Site

Hamilton, Ontario, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Saskatchewan, Saskatchewan, Canada

Novartis Investigative Site

Vancouver, , Canada

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Großhansdorf, , Germany

Novartis Investigative Site

Hanover, , Germany

Novartis Investigative Site

Mainz, , Germany

Countries

Canada; Germany

References

Gauvreau GM, Hohlfeld JM, FitzGerald JM, Boulet LP, Cockcroft DW, Davis BE, Korn S, Kornmann O, Leigh R, Mayers I, Watz H, Grant SS, Jain M, Cabanski M, Pertel PE, Jones I, Lecot JR, Cao H, O'Byrne PM. Inhaled anti-TSLP antibody fragment, ecleralimab, blocks responses to allergen in mild asthma. Eur Respir J. 2023 Mar 9;61(3):2201193. doi: 10.1183/13993003.01193-2022. Print 2023 Mar.

Reference Type: DERIVED

PMID: 36822634 (View on PubMed)

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17681

Results for CCSJ117X2201 from the Novartis Clinical Trials Website

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=609

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

2016-004929-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCSJ117X2201

Identifier Type: -

Identifier Source: org_study_id