AsthmaPhase 2NCT03650400

Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma

A Phase 2 study testing Fevipiprant in people with Asthma, run by Novartis Pharmaceuticals at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 6 to 11 years
Conditions the study is for: Asthma
What is being tested?: Fevipiprant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 6 sitesUnited States
Study dates: 1 May 2019to 22 Jan 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children
Written informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.
Confirmed/documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 6 months prior to study enrollment.
Subjects using asthma rescue medication (e.g. SABA) without asthma controller therapy or patients receiving daily treatment with a stable dose ICS (with or without additional controller such as long-acting β-agonists (LABA), long-acting muscarinic antagonists (LAMA)) for at least 4 weeks prior to Treatment Visit (Day 1).
Subjects must be able to attend study visits as per Study Visit Assessment Schedule (Section 8) which includes 8 to 9 hours in the clinic/home on the day of End of Treatment Visit and have blood draws as scheduled in the study.

Who cannot join

Use of other investigational drugs within 5 half-lives of enrollment, or (within 30 days (for small molecules)/until the expected pharmacodynamic effect has returned to baseline (for biologics)), whichever is longer.
Subject is unable to ingest banana and/or yogurt
History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease).
History of active bacterial, viral or fungal infection within 6 weeks of Treatment Visit (Day 1).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Novartis Investigative Site
Boerne, Texas, 78006
Novartis Investigative Site
Columbia, Missouri, 65203
Novartis Investigative Site
El Paso, Texas, 79903
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
Tulsa, Oklahoma, 74136

Other trials in United States

About this study

Official title: A Multicenter, Open-label, 8 Day Treatment Study to Assess the Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to <12 Years With Asthma

The purpose of this study was to assess the pharmacokinetics (PK) of fevipiprant (QAW039) delivered as a chewable tablet (CT) in pediatric asthma subjects aged 6 to < 12 years with asthma. The results of this study will support the identification of a fevipiprant dose for subsequent pediatric efficacy studies aiming to provide an exposure similar to that of the to-be marketed adult/adolescent dose. In addition, the first data on safety and tolerability of fevipiprant in this age group was obtained.

Read the detailed description

The purpose of this study was to assess the pharmacokinetics (PK) of fevipiprant delivered as a chewable tablet (CT) in pediatric asthma subjects aged 6 to < 12 years. The results of this study would have supported the identification of a fevipiprant dose for subsequent pediatric efficacy studies aiming to provide an exposure similar to that of the to-be marketed adult/adolescent dose. Based on evaluation of the fevipiprant asthma development program in the recently completed studies (CQAW039A2307/ CQAW039A2314) in the adult population (the analyses of these studies did not meet the clinically relevant threshold for reduction in rate of moderate-to-severe exacerbation compared to placebo over a 52-week treatment period for either of the doses [i.e. 150 mg/ 450 mg]), Novartis decided to discontinue this study (CQAW039B2201).

Conditions: Asthma
Being tested: Fevipiprant
Keywords: Fevipiprant,, GINA 2018,, Pediatrics
Medical subject headings: Asthma

What participants receive

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

FevipiprantDrug
Also called QAW039
Chewable tablet

Study groups in NCT03650400
Study group	Role	What they receive
Cohort A Fevipiprant 75 mg	Experimental	QAW039 75 mg Chewable tablet Receives: Drug: Fevipiprant
Cohort B Feviprant 375 mg	Experimental	QAW039 375 mg Chewable tablet Receives: Drug: Fevipiprant

What is being measured

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

Pharmacokinetics of Fevipiprant by Area Under the Curve From 0 to 24 Hours at Steady State (AUC0-24h,ss), After at Least Four Consecutive Days of Dosing
Area under the curve (AUC0-24h,ss), steady state following drug administration
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of Fevipiprant by Maximum Plasma Concentration at Steady State (Cmax,ss), After at Least Four Consecutive Days of Dosing
Maximum plasma concentration (Cmax,ss) steady state following drug administration.
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of Fevipiprant by Oral Clearance at Steady State (CL/F), After at Least Four Consecutive Days of Dosing
Oral clearance (CL/F), steady state following drug administration.
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Secondary outcomes (9)

Pharmacokinetics of Fevipiprant by CL/F
Pharmacokinetics of fevipiprant by oral clearance (CL/F) at steady state
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
Pharmacokinetics of Fevipiprant by Tmax,ss
Pharmacokinetics of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Urinary Excretion of Fevipiprant
CLr, amount and fraction of dose excreted over the PK collection interval at steady state, of fevipiprant
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
Pharmacokinetics of Fevipiprant by Cmin,ss
Pharmacokinetics of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of the Metabolite CCN362 by AUC0-24h,ss
Pharmacokinetics of CCN362 metabolite of fevipiprant , area under the curve (AUC0-24h,ss) at steady state.
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of the Metabolite CCN362 by Cmax,ss
Pharmacokinetics of CCN362 metabolite of fevipiprant by maximum plasma concentration (Cmax,ss) at steady state
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of the Metabolite CCN362 by Cmin,ss
Pharmacokinetics of CCN362 metabolite of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of the Metabolite CCN362 by Tmax,ss
Pharmacokinetics of CCN362 metabolite of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Urinary Excretion of the Metabolite, CCN362
CLr, amount and fraction of dose excreted over the PK collection interval at steady state, of the metabolite, CCN362
Measured: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.

Timeline

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

1 May 201922 Jan 2020

First posted28 Aug 2018
Study start1 May 2019
Primary completion16 Dec 2019
Study completion22 Jan 2020

Why it stopped: Company Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: There will be 2 treatment dose cohorts studied (fevipiprant dose A once daily and one higher dose selected based on PK obtained at dose A mg/day, fevipiprant dose B once daily). Within each dose cohort, subjects will be stratified approximately 1:1 ratio into 2 age groups: ages 6 to \< 9 years and ages 9 to \< 12 years.
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03650400
Sponsor's protocol ID: CQAW039B2201
Status last verified: Dec 2025
First submitted: 27 Aug 2018
Last updated: 13 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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 https://www.clinicalstudydatarequest.com/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, 8 Day Treatment Study to Assess the Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to <12 Years With Asthma
ClinicalTrials.gov ID: NCT03650400
Acronym / sponsor ID: CQAW039B2201
Conditions: Asthma
Keywords: Fevipiprant,, GINA 2018,, Pediatrics
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Company Decision
Enrolment: 11 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 1 May 2019 (actual)
Primary completion: 16 Dec 2019 (actual)
Study completion: 22 Jan 2020 (actual)
First posted: 28 Aug 2018 (actual)
Results: Posted 20 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: There will be 2 treatment dose cohorts studied (fevipiprant dose A once daily and one higher dose selected based on PK obtained at dose A mg/day, fevipiprant dose B once daily). Within each dose cohort, subjects will be stratified approximately 1:1 ratio into 2 age groups: ages 6 to < 9 years and ages 9 to < 12 years.

Arm	Type	Receives
Cohort A Fevipiprant 75 mg	Experimental	Drug: FevipiprantQAW039 75 mg Chewable tablet
Cohort B Feviprant 375 mg	Experimental	Drug: FevipiprantQAW039 375 mg Chewable tablet

Who may qualify

Ages: 6 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Children
Written informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.
Confirmed/documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 6 months prior to study enrollment.
Subjects using asthma rescue medication (e.g. SABA) without asthma controller therapy or patients receiving daily treatment with a stable dose ICS (with or without additional controller such as long-acting β-agonists (LABA), long-acting muscarinic antagonists (LAMA)) for at least 4 weeks prior to Treatment Visit (Day 1).
Subjects must be able to attend study visits as per Study Visit Assessment Schedule (Section 8) which includes 8 to 9 hours in the clinic/home on the day of End of Treatment Visit and have blood draws as scheduled in the study.

Key exclusion criteria (5 listed)

Use of other investigational drugs within 5 half-lives of enrollment, or (within 30 days (for small molecules)/until the expected pharmacodynamic effect has returned to baseline (for biologics)), whichever is longer.
Subject is unable to ingest banana and/or yogurt
History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease).
History of active bacterial, viral or fungal infection within 6 weeks of Treatment Visit (Day 1).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FevipiprantAlso: QAW039Chewable tablet	Drug	Cohort A Fevipiprant 75 mg, Cohort B Feviprant 375 mg

Primary outcome

Pharmacokinetics of Fevipiprant by Area Under the Curve From 0 to 24 Hours at Steady State (AUC0-24h,ss), After at Least Four Consecutive Days of Dosing
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Area under the curve (AUC0-24h,ss), steady state following drug administration
Pharmacokinetics of Fevipiprant by Maximum Plasma Concentration at Steady State (Cmax,ss), After at Least Four Consecutive Days of Dosing
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Maximum plasma concentration (Cmax,ss) steady state following drug administration.
Pharmacokinetics of Fevipiprant by Oral Clearance at Steady State (CL/F), After at Least Four Consecutive Days of Dosing
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Oral clearance (CL/F), steady state following drug administration.

9 secondary outcomes

Pharmacokinetics of Fevipiprant by CL/F
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
Pharmacokinetics of Fevipiprant by Tmax,ss
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Urinary Excretion of Fevipiprant
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
Pharmacokinetics of Fevipiprant by Cmin,ss
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of the Metabolite CCN362 by AUC0-24h,ss
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of the Metabolite CCN362 by Cmax,ss
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of the Metabolite CCN362 by Cmin,ss
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Pharmacokinetics of the Metabolite CCN362 by Tmax,ss
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Urinary Excretion of the Metabolite, CCN362
Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.

Results and safety

Results posted to the registry on 20 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A Fevipiprant 75 mg	6	6
Cohort B Feviprant 375 mg	5	0

Primary outcome: Pharmacokinetics of Fevipiprant by Area Under the Curve From 0 to 24 Hours at Steady State (AUC0-24h,ss), After at Least Four Consecutive Days of Dosing

Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours). Mean (Standard Deviation). Unit: h*ng/mL

Measure	Cohort A Fevipiprant 75 mg n = 6	Cohort B Feviprant 375 mg n = 0
Value	2380 (1880)	–

Population analysed: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Primary outcome: Pharmacokinetics of Fevipiprant by Maximum Plasma Concentration at Steady State (Cmax,ss), After at Least Four Consecutive Days of Dosing

Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours). Mean (Standard Deviation). Unit: ng/mL

Measure	Cohort A Fevipiprant 75 mg n = 6	Cohort B Feviprant 375 mg n = 0
Value	394 (286)	–

Population analysed: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Primary outcome: Pharmacokinetics of Fevipiprant by Oral Clearance at Steady State (CL/F), After at Least Four Consecutive Days of Dosing

Time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours). Mean (Standard Deviation). Unit: L/h

Measure	Cohort A Fevipiprant 75 mg n = 6	Cohort B Feviprant 375 mg n = 0
Value	48.2 (32)	–

Population analysed: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 38 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A Fevipiprant 75 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort B Feviprant 375 mg	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
A Pediatric Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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 https://www.clinicalstudydatarequest.com/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fevipiprant in people with Asthma, run by Novartis Pharmaceuticals at 6 sites in United States.

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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pharmacokinetics of Fevipiprant by Area Under the Curve From 0 to 24 Hours at Steady State (AUC0-24h,ss), After at Least Four Consecutive Days of Dosing (time frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)). 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 NCT03650400.

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 13 Jan 2026.