NCT03138811

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 asthma

Timeline
Completed

Started Dec 2017

Typical duration for phase_1 asthma

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

December 18, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

May 1, 2017

Last Update Submit

October 7, 2021

Conditions

Asthma

Keywords

asthmaallergen bronchoprovocationpharmacodynamicspharmacokineticssafetytolerability

Outcome Measures

Primary Outcomes (3)

  • Number of adverse events and serious adverse events

    An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that is given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug are classified as a treatment emergent adverse event.

    12 weeks

  • Late asthmatic response as measured by the AUC for time adjusted percent decrease in FEV1

    Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The AUC for time adjusted percent decrease in FEV1 will be compared between CSJ117 and placebo groups.

    12 weeks

  • Late asthmatic response as measured by the maximum percentage decrease in FEV1

    Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The maximum percentage decrease in FEV1 will be compared between CSJ117 and placebo groups.

    12 weeks

Secondary Outcomes (13)

  • Early asthmatic response as measured by the time adjusted AUC percent decrease in FEV1

    6 weeks and 12 weeks

  • Early asthmatic response as measured by the maximum percentage decrease in FEV1

    6 weeks and 12 weeks

  • Early asthmatic response as measured by the minimum of the absolute in FEV1

    6 weeks and 12 weeks

  • Late asthmatic response as measured by the time adjusted AUC in FEV1

    6 weeks

  • Late asthmatic response as measured by the maximum percentage decrease in FEV1

    6 weeks

  • +8 more secondary outcomes

Study Arms (2)

CSJ117

EXPERIMENTAL

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

Drug: CSJ117

Placebo

PLACEBO COMPARATOR

placebo comparator administered as once daily inhaled dose

Drug: Placebo Comparator

Interventions

CSJ117DRUG

inhaled once daily dose

CSJ117
Placebo ComparatorDRUG

inhaled once daily dose

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novartis Investigative Site

Calgary, Alberta, T2N 4N1, Canada

Location

Novartis Investigative Site

Edmonton, Alberta, T6G 2B7, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Novartis Investigative Site

Québec, Quebec, G1V 4G5, Canada

Location

Novartis Investigative Site

Saskatchewan, Saskatchewan, S7K 0M7, Canada

Location

Novartis Investigative Site

Vancouver, Canada

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

Großhansdorf, 22927, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36822634DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 3, 2017

Study Start

December 18, 2017

Primary Completion

July 16, 2019

Study Completion

July 16, 2019

Last Updated

October 12, 2021

Record last verified: 2021-10

Locations

DE(4)CA(6)