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AsthmaPhase 1NCT03138811

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

A Phase 1 study testing CSJ117 in people with Asthma, run by Novartis Pharmaceuticals at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Asthma
What is being tested?
CSJ117
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
10 sitesin 2 countries
Study dates
18 Dec 2017to 16 Jul 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Canada6 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N1

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2B7

  • Novartis Investigative Site

    Hamilton, Ontario, L8N 3Z5

  • Novartis Investigative Site

    Québec, Quebec, G1V 4G5

  • Novartis Investigative Site

    Saskatchewan, Saskatchewan, S7K 0M7

  • Novartis Investigative Site

    Vancouver

Other trials in Canada

Germany4 sites

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Großhansdorf, 22927

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Mainz, 55131

Other trials in Germany

About this study

Official title: A Randomized, Subject- and Investigator-blinded, Placebo-controlled, Paralleldesign, Bronchoprovocation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Inhaled CSJ117 in Adult Subjects With Mild Atopic Asthma

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
Being tested
CSJ117, Placebo Comparator
Keywords
asthma, allergen bronchoprovocation, pharmacodynamics, pharmacokinetics, safety, tolerability
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSJ117Drug

    inhaled once daily dose

  • Placebo ComparatorDrug

    inhaled once daily dose

Study groups in NCT03138811
Study groupRoleWhat they receive
CSJ117Experimentallow dose, medium dose, or high dose administered as a once daily inhaled dose
Receives: Drug: CSJ117
PlaceboPlacebo comparatorplacebo comparator administered as once daily inhaled dose
Receives: Drug: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

Secondary outcomes (13)

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

    Early asthmatic response (EAR) is considered a ≥ 20% fall in FEV1 within the 2 hours after an allergen inhalation challenge. The time adjusted AUC percent decrease will be compared between CSJ117 and placebo groups.

    Measured: 6 weeks and 12 weeks

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

    Early asthmatic response (EAR) is considered a ≥ 20% fall in FEV1 within the 2 hours after an allergen inhalation challenge. The maximum percentage decrease will be compared between CSJ117 and placebo groups.

    Measured: 6 weeks and 12 weeks

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

    Early asthmatic response (EAR) is considered a ≥ 20% fall in FEV1 within the 2 hours after an allergen inhalation challenge. The minimum of the absolute in FEV1 will be compared between CSJ117 and placebo groups.

    Measured: 6 weeks and 12 weeks

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

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

    Measured: 6 weeks

  5. 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.

    Measured: 6 weeks

  6. Late asthmatic response as measured by the minimum absolute FEV1

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

    Measured: 6 weeks and 12 weeks

  7. Measurement of CSJ117 serum concentration and calculation of Tmax

    Tmax is the time to reach the maximum concentration after drug administration

    Measured: 12 weeks

  8. Measurement of CSJ117 serum concentration and calculation of Cmax

    Cmax is the observed maximum plasma concentration following drug administration

    Measured: 12 weeks

  9. Measurement of CSJ117 serum concentration and calculation of AUCtau

    The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau [mass x time / volume]

    Measured: 12 weeks

  10. Measurement of CSJ117 serum concentration and calculation of Ctrough)

    Ctrough is the observed serum (or plasma or blood) concentration that is just prior to the beginning of, or at the end of, a dosing interval.

    Measured: 12 weeks

  11. Measurement of CSJ117 serum concentration and calculation of Racc

    Racc is the accumulation ratio

    Measured: 12 weeks

  12. Measurement of CSJ117 serum concentration and calculation of Lambda_z

    Lambda_z is the apparent elimination rate constant

    Measured: 12 weeks

  13. Measurement of CSJ117 serum concentration and calculation of T1/2

    T1/2 is the terminal elimination half-life [time]

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2017
  2. Study start18 Dec 2017
  3. Primary completion16 Jul 2019
  4. Study completion16 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03138811
Sponsor's protocol ID
CCSJ117X2201
Other IDs
2016-004929-16, 2016
Status last verified
Oct 2021
First submitted
1 May 2017
Last updated
12 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • 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.

    PubMed 36822634

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CSJ117 in people with Asthma, run by Novartis Pharmaceuticals at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events and serious adverse events (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03138811, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.

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