Clinical Trials Register

Summary
EudraCT Number:	2018-004381-33
Sponsor's Protocol Code Number:	CQAW039A2127
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-06-20
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2018-004381-33

A.3

Full title of the trial

Randomized, subject and investigator blinded, placebo-controlled
study to demonstrate the anti-inflammatory
effect of fevipiprant (QAW039) in moderate-severe asthma
patients with high sputum and blood eosinophils

Etude randomisée contrôlée contre placebo, en double aveugle (patients et investigateurs), destinée à démontrer l'effet anti-inflammatoire du fevipiprant (QAW039) chez des patients
atteints d’asthme modéré à sévère et présentant des taux élevés d’éosinophiles dans le sang et les expectorations

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A proof-of-mechanism study to demonstrate the anti-inflammatory effect of fevipiprant in moderate to severe asthma patients with high sputum and blood eosinophils

A.4.1

Sponsor's protocol code number

CQAW039A2127

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Pharma AG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novartis Pharma AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Pharma S.A.S
B.5.2	Functional name of contact point	Information&Communication Médicales
B.5.3	Address:
B.5.3.1	Street Address	2 et 4 rue Lionel Terray
B.5.3.2	Town/ city	Rueil-Malmaison
B.5.3.3	Post code	92500
B.5.3.4	Country	France
B.5.4	Telephone number	+33 1 5547 6600
B.5.5	Fax number	+33 1 5547 6100
B.5.6	E-mail	icm.phfr@novartis.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fevipiprant
D.3.2	Product code	QAW039
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fevipiprant
D.3.9.1	CAS number	872365-14-5
D.3.9.2	Current sponsor code	QAW039
D.3.9.3	Other descriptive name	QAW039-NXA.001
D.3.9.4	EV Substance Code	SUB32073
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	450
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Asthma

E.1.1.1

Medical condition in easily understood language

Asthma

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the change from baseline in sputum eosinophil levels after 12 weeks of treatment with fevipiprant compared to placebo in asthma patients with sputum eosinophilia

E.2.2

Secondary objectives of the trial

To assess safety and tolerability of fevipiprant compared to placebo in
asthma patients with sputum eosinophilia

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All Subjects (Asthma patients, Healthy volunteers):
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female subjects aged ≥ 18 years at screening
3. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Moderate-to-severe asthma patients (Asthma patients):
1. Patients with a diagnosis of asthma currently treated with 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.
2. A clinical diagnosis of asthma supported by at least one of the following within five years prior to screening :
- 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.
3. ACQ7 score ≥ 1.25 at screening and baseline visits, which may be repeated once at each visit.
4. Demonstrate ability to produce a good quality induced-sputum sample at baseline visits.
Note: Sputum induction test may be repeated once at each applicable visit.
5. Sputum eosinophil count ≥ 2% and blood eosinophil count ≥ 250 cells/μL at applicable screening (visit 1) and baseline visits (visit 20 and visit 30).
Note: Re-testing is allowed once to qualify patient at that visit.

Healthy volunteers (Healthy volunteers):
1. Subject must be in good health as determined by past medical history, current medications, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
Note: Subjects with well-controlled, mild, non-respiratory diseases can participate as long as they are considered healthy and stable in the investigator's judgement.

E.4

Principal exclusion criteria

All Subjects (Asthma patients, Healthy volunteers):
1. 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.
2. Cirrhosis, hepatic failure, chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). At screening, a positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, excludes a subject. Subjects with a positive HCV antibody test should have HCV RNA levels measured. Subjects with positive (detectable) HCV RNA should be excluded.
3. At screening, a positive HIV test or is taking anti-retroviral medications, as determined by medical history and/or subject’s verbal report.
4. 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 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
5. Donation or loss of 450 mL or more of blood within eight weeks prior to screening visit or longer if required by local regulation.
6. Plasma donation (>150 mL) within 30 days prior to screening visit.
7. History of drug or alcohol abuse within the 12 months prior to screening visit.
8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless using basic methods of contraception
9. At screening, pregnant or nursing (lactating) women.
10. History of parasitic infestation within 6 months prior to screening
Moderate-to-severe asthma patients (Asthma patients):
1. 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, chronic eosinophilic pneumonia, Churg-Strauss Syndrome).
2. History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes
3. 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).
4. Patients on statin therapy with a CK level >2 X ULN at screening.
5. Patients on prohibited treatment listed in Table 6-2.
6. Patients who have had an asthma exacerbation requiring systemic corticosteroids, hospitalization, or emergency room visit within 4 weeks prior to and/or during screening or baseline.
7. Patients who have had a respiratory tract infection or asthma worsening within 4 weeks of screening.
8. Subjects who have smoked or inhaled any foreign substance (marijuana, etc.) other than asthma medications within the 4 week period prior to screening, or who have a cigarette
smoking history of greater than 10 pack years (Note: 10 pack years = 1 pack/day during 10 yrs., or ½ pack/day during 20 yrs.) or positive test for continine at the time of screening.
9. Patients with a history of myocardial infarction within 12 months of screening.
10. History or current diagnosis of ECG abnormalities indicating significant risk of safety
11. Any severe, progressive or uncontrolled, acute or chronic, medical or
psychiatric condition
12. Patients who have a clinically significant laboratory abnormality at
screening or baseline visit
13. 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.
14. Use of immunosuppressive medication within 4 weeks prior to
screening. Inhaled and topical glucocorticoids and low dose (≤15mg
prednisolone/day) oral corticosteroids are permitted.
Healthy volunteers (Healthy volunteers):
1. History of allergies or atopy (e.g., allergic rhinitis, urticaria,
eczematous dermatitis).
2. Recent (within three years of screening) and/or recurrent history of
acute or chronic obstructive disease (including asthma and chronic
obstructive pulmonary disease, treated or not treated).
3. Use of any prescription drugs, herbal supplements, prescribed
medicinal use of cannabis/marijuana, within four weeks prior to
screening assessments, and/or (OTC) medication, dietary supplements
(vitamins included) within two weeks prior to screening.
4. Significant illness, which has not resolved within two weeks prior to
screening.
5. Patients who have smoked or inhaled any foreign substance (nicotine,
marijuana, etc.) within the 4 week period prior to screening, or who
have a cigarette smoking history of greater than 10 pack years (Note: 10
pack years = 1 pack/day during 10 yrs., or ½ pack/day during 20 yrs.),
or positive test for continine at the time of screening.

E.5 End points

E.5.1

Primary end point(s)

Sputum eosinophil % of total cell count on Day 84

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 84

E.5.2

Secondary end point(s)

Vital signs, ECG parameters, clinical safety laboratory parameters
(chemistry/hematology/urinalysis), (serious) adverse events

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 84

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LSLV

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-08-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-08-22

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2019-12-16

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