AsthmaPhase 2NCT03989635
Mechanistic Study of Anti-inflammatory Effects of Fevipiprant in Patients With Eosinophilic Asthma.
A Phase 2 study testing QAW039 in people with Asthma and Asthma, Bronchial, run by Novartis Pharmaceuticals.
Trial summary
This is an exploratory, randomized, subject- and investigator-blinded, placebo-controlled mode-of-action study to demonstrate the anti-inflammatory effects of fevipiprant compared to placebo after 12 weeks of treatment in 48 moderate to severe asthma patients with sputum and blood eosinophilia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Asthma, Bronchial, Bronchial Asthma
- What is being tested?
- QAW039
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2019to 14 Jun 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Subjects (Asthma patients and healthy volunteers):
- Written informed consent must be obtained before any assessment is performed.
- Male and female subjects aged ≥ 18 years.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- Asthma patients:
- Patients with a diagnosis of asthma currently prescribed at least medium dose of ICS, alone or with any other asthma controller therapy, except those listed as prohibited medications. Patients must be on stable doses of asthma medications for at least 4 weeks prior to screening.
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- A clinical diagnosis of asthma supported by at least one of the following within the last five years
- Reversible airway obstruction defined as an increase of ≥ 12% and ≥ 200 ml in FEV1 or FVC over the patient's pre-bronchodilator value within 30 minutes after inhaling a total of 360 μg of albuterol or 400 μg salbutamol via metered dose inhaler (reversibility test)
- A positive airway hyper-reactivity (AHR) test result defined as a provoked fall in FEV1 of 20% (PC20) by methacholine at ≤ 8 mg/ml when not on ICS or ≤ 16 mg/ml on ICS therapy
- A change in FEV1 of ≥ 12% over two measurements within 12 months.
- ACQ7 score ≥ 1.25 at screening and baseline visits and may be repeated once at each visit.
- Demonstrate ability to produce a good quality induced-sputum sample at baseline visit.
- Sputum eosinophil count ≥ 2% and blood eosinophil count ≥ 250cells/μL at applicable screening and baseline visits.
- Healthy volunteers:
- Subject must be in good health as determined by past medical history, current medications, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Subjects with well-controlled, mild, non-respiratory diseases can participate as long as they are considered healthy and stable in the investigator's judgement.
Who cannot join
- All Subjects (Asthma patients and healthy volunteers):
- Use of other investigational drugs at the time of screening, or within 5 half-lives of experimental drug at the time of screening, or within 30 days of last dose of experimental drug at the time of screening, whichever is longer; or longer if required by local regulations.
- A positive human immunodeficiency virus test or is taking anti-retroviral medications, as determined by medical history and/or subject's verbal report.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Donation or loss of 450 mL or more of blood within eight weeks prior to screening visit or longer if required by local regulation.
- Pregnant or nursing (lactating) women.
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- Asthma patients:
- Patients with a current or past medical history of conditions other than asthma or allergic rhinitis that could result in elevated blood or sputum eosinophils (e.g., hypereosinophilic syndrome, Churg-Strauss Syndrome).
- History of hypersensitivity to any of the study treatments or excipients (such as milk or lactose) or to drugs of similar chemical classes (other DP2 antagonists such as timapiprant).
- Patients with history of concomitant chronic or severe pulmonary disease other than asthma (e.g., COPD, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, active tuberculosis).
- Use of biologic therapy for asthma (e.g. omalizumab, mepolizumab, benralizumab, dupilumab) within 3 months or 5 half-lives prior to screening, whichever is longer.
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects participating in the study such as:
- Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and second or third degree AV block without a pacemaker
- History of familial long QT syndrome or known family history of Torsades de Point Resting QTcF (Fredericia) ≥ 450 msec (male) or ≥ 460 msec (female) at screening
- Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study.
- Patients on statin therapy with a CK level >2 X ULN at screening.
- Patients who have a clinically significant laboratory abnormality at screening including but not limited to:
- Total white blood cell count < 2500 cells/μL
- AST or ALT > 2.0 X ULN or total bilirubin > 1.3 X ULN
- Estimated Glomerular Filtration Rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation < 55 mL/minute/1.73m2.
- Healthy volunteers:
- History of allergies or atopy (e.g., allergic rhinitis, urticaria, eczematous dermatitis).
- Recent (within the last three years) and/or recurrent history of acute or chronic obstructive disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- Use of any prescription drugs, herbal supplements, prescribed medicinal use of cannabis/marijuana, within four weeks prior to screening assessments, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two weeks prior to screening. If needed, (i.e. an incidental and limited need) paracetamol/acetaminophen is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF.
- Significant illness, which has not resolved within two weeks prior to screening.
About this study
Official title: Randomized, Subject and Investigator Blinded, Placebo-controlled Study to Demonstrate the Anti-inflammatory Effect of Fevipiprant (QAW039) in Moderate to Severe Asthma Patients With High Sputum and Blood Eosinophils.
This is an exploratory, randomized, subject- and investigator-blinded, placebo-controlled mode-of-action study to demonstrate the anti-inflammatory effects of fevipiprant compared to placebo after 12 weeks of treatment in 48 moderate to severe asthma patients with sputum and blood eosinophilia.
Read the detailed description
The main purpose of this study is to demonstrate the anti-inflammatory effects of fevipiprant (QAW039) compared to placebo after 12 weeks of treatment in moderate to severe asthma patients with an elevated sputum eosinophil count (≥ 2%) and high blood eosinophil count (≥ 250 cells/μL). This study is also designed to investigate the effects of fevipiprant on key inflammatory cells bearing the DP2 receptor (such as eosinophils, Th2/Tc2 cells, and ILC2 cells) in sputum and blood.
- Being tested
- QAW039
- Keywords
- QAW039, Asthma, Sputum, Eosinophilia, eosinophillic, Prostaglandin D2 receptor, DP2, Fevipiprant.
- Medical subject headings
- Asthma, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAW039Drug
Also called Fevipiprant
QAW039 450mg
| Study group | Role | What they receive |
|---|---|---|
| QAW039 | Experimental | QAW039 450mg Receives: Drug: QAW039 |
| Placebo | Placebo comparator | Placebo to QAW039 Receives: Drug: QAW039 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum eosinophil % of total cell count
To assess the change from baseline in
sputum eosinophil levels after 12 weeks of treatment with fevipiprant compared to placebo in moderate to severe asthma patients with sputum and blood eosinophilia.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start15 Oct 2019 (estimated)
- Primary completion14 Jun 2021 (estimated)
- Study completion14 Jun 2021 (estimated)
Why it stopped: Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-confirmatory, mode-of-action, placebo-controlled, parallel group, randomized, subject and investigator blinded study in 48 moderate to severe asthma patients, who are on at least medium dose ICS, with or without other asthma controller and with elevated sputum eosinophils count of ≥ 2% of the total cell count from an induced sputum specimen and a peripheral eosinophil count ≥ 250 cells/μL of blood. They should be on standard of care asthma medications for 4 weeks prior to screening with no past or current medical history of other chronic or severe pulmonary diseases. Randomized patients will be treated with fevipiprant or matching placebo for up to 98 days. A group of 10 healthy subjects will also be recruited to examine baseline levels of prostaglandins and DP2-related biomarkers and compare them to biomarker data from asthma patients at baseline and after therapy with fevipiprant. Healthy volunteers will not receive study treatment. .
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989635
- Sponsor's protocol ID
- CQAW039A2127
- Status last verified
- May 2020
- First submitted
- 14 Jun 2019
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Subject and Investigator Blinded, Placebo-controlled Study to Demonstrate the Anti-inflammatory Effect of Fevipiprant (QAW039) in Moderate to Severe Asthma Patients With High Sputum and Blood Eosinophils.
- ClinicalTrials.gov ID
- NCT03989635
- Acronym / sponsor ID
- CQAW039A2127
- Keywords
- QAW039, Asthma, Sputum, Eosinophilia, eosinophillic, Prostaglandin D2 receptor, DP2, Fevipiprant.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 14 Jun 2021 (estimated)
- Study completion
- 14 Jun 2021 (estimated)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory, randomized, subject- and investigator-blinded, placebo-controlled mode-of-action study to demonstrate the anti-inflammatory effects of fevipiprant compared to placebo after 12 weeks of treatment in 48 moderate to severe asthma patients with sputum and blood eosinophilia.
Detailed description
The main purpose of this study is to demonstrate the anti-inflammatory effects of fevipiprant (QAW039) compared to placebo after 12 weeks of treatment in moderate to severe asthma patients with an elevated sputum eosinophil count (≥ 2%) and high blood eosinophil count (≥ 250 cells/μL). This study is also designed to investigate the effects of fevipiprant on key inflammatory cells bearing the DP2 receptor (such as eosinophils, Th2/Tc2 cells, and ILC2 cells) in sputum and blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a non-confirmatory, mode-of-action, placebo-controlled, parallel group, randomized, subject and investigator blinded study in 48 moderate to severe asthma patients, who are on at least medium dose ICS, with or without other asthma controller and with elevated sputum eosinophils count of ≥ 2% of the total cell count from an induced sputum specimen and a peripheral eosinophil count ≥ 250 cells/μL of blood. They should be on standard of care asthma medications for 4 weeks prior to screening with no past or current medical history of other chronic or severe pulmonary diseases. Randomized patients will be treated with fevipiprant or matching placebo for up to 98 days. A group of 10 healthy subjects will also be recruited to examine baseline levels of prostaglandins and DP2-related biomarkers and compare them to biomarker data from asthma patients at baseline and after therapy with fevipiprant. Healthy volunteers will not receive study treatment. .
| Arm | Type | Receives |
|---|---|---|
| QAW039 | Experimental | Drug: QAW039QAW039 450mg |
| Placebo | Placebo comparator | Drug: QAW039Placebo to QAW039 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent must be obtained before any assessment is performed.
- Male and female subjects aged ≥ 18 years.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- Patients with a diagnosis of asthma currently prescribed at least medium dose of ICS, alone or with any other asthma controller therapy, except those listed as prohibited medications. Patients must be on stable doses of asthma medications for at least 4 weeks prior to screening.
- A clinical diagnosis of asthma supported by at least one of the following within the last five years
Key exclusion criteria (25 listed)
- Use of other investigational drugs at the time of screening, or within 5 half-lives of experimental drug at the time of screening, or within 30 days of last dose of experimental drug at the time of screening, whichever is longer; or longer if required by local regulations.
- A positive human immunodeficiency virus test or is taking anti-retroviral medications, as determined by medical history and/or subject's verbal report.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Donation or loss of 450 mL or more of blood within eight weeks prior to screening visit or longer if required by local regulation.
- Pregnant or nursing (lactating) women.
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 |
|---|---|---|
| QAW039Also: FevipiprantQAW039 450mg | Drug | Placebo, QAW039 |
Primary outcome
Sputum eosinophil % of total cell count
Time frame: 12 weeks
To assess the change from baseline in sputum eosinophil levels after 12 weeks of treatment with fevipiprant compared to placebo in moderate to severe asthma patients with sputum and blood eosinophilia.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: 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
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAW039 in people with Asthma and Asthma, Bronchial, run by Novartis Pharmaceuticals.
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 16 inclusion and 25 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: withdrawn, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sputum eosinophil % of total cell count (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2020.