Clinical Trials Register

Summary
EudraCT Number:	2016-001560-11
Sponsor's Protocol Code Number:	CQAW039A2315
National Competent Authority:	Romania - National Agency for Medicines and Medical Devices
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-06-08
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

Romania - National Agency for Medicines and Medical Devices

A.2

EudraCT number

2016-001560-11

A.3

Full title of the trial

A 2-treatment period, randomized, placebo-controlled, multicenter parallel-group study to assess the safety of QAW039 when added to existing asthma therapy in GINA steps 3, 4 and 5 patients with uncontrolled asthma.

Studiu multicentric, randomizat, controlat cu placebo, cu grupe paralele, cu 2 perioade de tratament, pentru a evalua siguranța QAW039 când se adaugă terapiei existente pentru astm bronșic la pacienți din GINA pașii 3, 4 și 5 cu astm bronșic necontrolat

A.3.1

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

Study of safety of QAW039 in patients (≥ 12 yrs) with asthma inadequately controlled on standard-of-care asthma therapy

A.3.2

Name or abbreviated title of the trial where available

SPIRIT

A.4.1

Sponsor's protocol code number

CQAW039A2315

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 Services Romania S.R.L.
B.5.2	Functional name of contact point	Alexandru Ionel, MD
B.5.3	Address:
B.5.3.1	Street Address	Strada Barbu Vacarescu nr. 301-311, etaj 1, sector 2
B.5.3.2	Town/ city	Bucuresti
B.5.3.3	Post code	020276
B.5.3.4	Country	Romania
B.5.4	Telephone number	+40 21 3129901
B.5.5	Fax number	+40 21 3129907
B.5.6	E-mail	dra.romania@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	150
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.IMP: 2
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
D.8 Placebo: 2
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

Treatment Period 1 (double-blind, 52-week treatment period):
In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
-treatment emergent adverse events (AEs);
-treatment emergent serious adverse events (SAEs); and
-study treatment discontinuations due to treatment emergent AEs.

Treatment Period 1 and Treatment Period 2 combined:
In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
-treatment emergent AEs
-treatment emergent SAEs; and
-study treatment discontinuations due to treatment emergent AEs.

E.2.2

Secondary objectives of the trial

Treatment Period 1 (double-blind, 52-week treatment period):
In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
-rate of patients with at least 1 treatment emergent AE by primary system organ class;
-rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation.

Treatment Period 1 and Treatment Period 2 combined:
In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
-rate of patients with at least 1 treatment emergent AE by primary system organ class; and
-rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients completing a prior Phase 3 study of QAW039:
- Informed consent and assent (if applicable).
-Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.
-Patient is able to safely continue into the study as judged by the investigator.

Patients who have not previously participated in a study of QAW039:
-Written informed consent.
-Male and female patients aged ≥12 years.
-A diagnosis of asthma, uncontrolled on GINA 3/4/5 asthma medication. -Evidence of airway reversibility or airway hyper- reactivity.
-FEV1 of ≤85% of the predicted normal value.
-An ACQ score ≥1.5 prior to entering the study.

E.4

Principal exclusion criteria

Patients completing a prior phase 3 study of QAW039:
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
- Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
- Inability to comply with all study requirements.
- Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.

Patients who have not previously participated in a study of QAW039:
-Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
-Subjects who have participated in another trial of QAW039.
-A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
-History of malignancy with the exception of local basal cell carcinoma of the skin.
-Pregnant or nursing (lactating) women.
-Serious co-morbidities.
-Patients on greater than 20 mg of simvastatin

E.5 End points

E.5.1

Primary end point(s)

-treatment emergent adverse events (AEs)
-treatment emergent serious adverse events
-treatment emergent AEs leading to treatment discontinuation

E.5.1.1

Timepoint(s) of evaluation of this end point

52 weeks (end Treatment Period 1)
160 weeks (end Treatment Period 2)

E.5.2

Secondary end point(s)

-Rate of patients with at least 1 treatment emergent AE by primary system organ class
-Rate of treatment emergent patient deaths for asthma exacerbations
-Rate of treatment emergent patient hospitalizations for an asthma exacerbation

E.5.2.1

Timepoint(s) of evaluation of this end point

52 weeks (end Treatment Period 1)
160 weeks (end Treatment Period 2)

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

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

E.8.1.7.1

Other trial design description

While Part 1 is double-blind, Part 2 is single-blind

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

160

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Brazil

Canada

China

Colombia

Egypt

Guatemala

India

Israel

Japan

Kuwait

Lebanon

Malaysia

Mexico

Peru

Philippines

Saudi Arabia

Singapore

Taiwan

United States

Austria

Estonia

Finland

France

Latvia

Lithuania

Poland

Bulgaria

Netherlands

Romania

Spain

Switzerland

Czechia

Germany

Greece

Belgium

Hungary

Russian Federation

Serbia

Slovakia

Turkey

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

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

LVLS: 15-Jul-2022

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

1333

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

157

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

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

892

F.4.2.2

In the whole clinical trial

1570

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)

Patients completing the study after Treatment Period 1 or Treatment Period 2 will not be given further access to study drug because the risk/benefit ratio will not yet have been substantiated and there are already other marketed therapeutic alternatives available to treat these patients. At the time of study completion or early termination, all patients will be placed on the appropriate asthma treatment as prescribed by the investigator.

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

2018-09-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-03-16

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