NCT03052517 is a Phase 3 clinical trial of QAW039 150 mg in Asthma, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT03052517?

NCT03052517 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03052517?

Interventions in NCT03052517: QAW039 150 mg, QAW039 450 mg, Placebo.

Is NCT03052517 still recruiting?

NCT03052517 is currently terminated. Last updated 12 October 2020.

Are results published for NCT03052517?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-12 · How we verify

NCT03052517

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

Terminated Phase 3 Results posted Last updated 12 October 2020

What this trial tests

Phase 3 trial testing QAW039 150 mg in Asthma in 2,538 participants. Terminated before completion.

Timeline

21 March 2017

Primary endpoint
19 February 2020

16 March 2020

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	2,538
Start date	21 March 2017
Primary completion	19 February 2020
Estimated completion	16 March 2020
Sites	347 locations across Colombia, Finland, Japan, Malaysia, Taiwan, Poland, Philippines, Lebanon

Drugs / interventions tested

QAW039 150 mg — full drug profile →
QAW039 450 mg — full drug profile →
Placebo

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

12 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model Primary · 52 weeks

Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported.

Group	Value	95% CI
QAW039 150mg	675
QAW039 450 mg	654
Placebo	237

Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model Primary · 156 weeks

Group	Value	95% CI
QAW039 150mg	709
QAW039 450 mg	681
Placebo	243

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model Primary · 52 weeks

Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported.

Group	Value	95% CI
QAW039 150mg	73
QAW039 450 mg	53
Placebo	29

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model Primary · 156 weeks

Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs.

Group	Value	95% CI
QAW039 150mg	86
QAW039 450 mg	63
Placebo	33

Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model Primary · 52 weeks

Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported.

Group	Value	95% CI
QAW039 150mg	26
QAW039 450 mg	33
Placebo	9

Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model Primary · 156 weeks

Group	Value	95% CI
QAW039 150mg	30
QAW039 450 mg	37
Placebo	9

Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model Secondary · 52 weeks

The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)

Number of patients with at least one AE

Group	Value	95% CI
QAW039 150mg	675
QAW039 450 mg	654
Placebo	237

Blood and lymphatic system disorders

Group	Value	95% CI
QAW039 150mg	21
QAW039 450 mg	10
Placebo	5

Cardiac disorders

Group	Value	95% CI
QAW039 150mg	11
QAW039 450 mg	26
Placebo	7

Congenital, familial and genetic disorders

Group	Value	95% CI
QAW039 150mg	1
QAW039 450 mg	3
Placebo	0

Ear and labyrinth disorders

Group	Value	95% CI
QAW039 150mg	16
QAW039 450 mg	9
Placebo	8

Endocrine disorders

Group	Value	95% CI
QAW039 150mg	2
QAW039 450 mg	6
Placebo	0

Eye disorders

Group	Value	95% CI
QAW039 150mg	13
QAW039 450 mg	11
Placebo	9

Gastrointestinal disorders

Group	Value	95% CI
QAW039 150mg	88
QAW039 450 mg	86
Placebo	32

Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model Secondary · 156 weeks

Number of patients with at least one AE

Group	Value	95% CI
QAW039 150mg	710
QAW039 450 mg	682
Placebo	243

Blood and lymphatic system disorders

Group	Value	95% CI
QAW039 150mg	23
QAW039 450 mg	12
Placebo	5

Cardiac disorders

Group	Value	95% CI
QAW039 150mg	16
QAW039 450 mg	34
Placebo	7

Congenital, familial and genetic disorders

Group	Value	95% CI
QAW039 150mg	1
QAW039 450 mg	3
Placebo	1

Ear and labyrinth disorders

Group	Value	95% CI
QAW039 150mg	18
QAW039 450 mg	13
Placebo	9

Endocrine disorders

Group	Value	95% CI
QAW039 150mg	5
QAW039 450 mg	7
Placebo	0

Eye disorders

Group	Value	95% CI
QAW039 150mg	16
QAW039 450 mg	14
Placebo	9

Gastrointestinal disorders

Group	Value	95% CI
QAW039 150mg	101
QAW039 450 mg	96
Placebo	38

Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52 Secondary · 52 weeks

The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

Group	Value	95% CI
QAW039 150mg	0
QAW039 450 mg	0
Placebo	0

Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156 Secondary · 156 weeks

The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

Group	Value	95% CI
QAW039 150mg	0
QAW039 450 mg	0
Placebo	0

Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52 Secondary · 52 weeks

Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE). Rate of exacerbations per person year = total number of exacerbations / total number of treatment years

Group	Value	95% CI
QAW039 150mg	0.04
QAW039 450 mg	0.02
Placebo	0.06

Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156 Secondary · 156 weeks

Group	Value	95% CI
QAW039 150mg	0.04
QAW039 450 mg	0.02
Placebo	0.05

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 7 days post treatment (30 days in the case of a serious AE), up to maximum duration of 156 weeks.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

QAW039 150 mg

Serious: 87/1092 (8%)

Deaths: 3/1092

QAW039 450 mg

Serious: 64/1084 (6%)

Deaths: 1/1084

Placebo

Serious: 33/361 (9%)

Deaths: 1/361

Serious adverse events (140 terms)

Reaction	System	QAW039 150 mg	QAW039 450 mg	Placebo
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Bronchitis	Infections and infestations	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Angina unstable	Cardiac disorders	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—
Septic shock	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	—	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—
Blood loss anaemia	Blood and lymphatic system disorders	—	—	—
Angina pectoris	Cardiac disorders	—	—	—
Arteriosclerosis coronary artery	Cardiac disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Cardiac failure	Cardiac disorders	—	—	—

Other adverse events (16 terms — click to expand)

Reaction	System	QAW039 150 mg	QAW039 450 mg	Placebo
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Bronchitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Blood creatinine increased	Investigations	—	—	—
Headache	Nervous system disorders	—	—	—
Sinusitis	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Pharyngitis	Infections and infestations	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—
Upper respiratory tract infection bacterial	Infections and infestations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Influenza	Infections and infestations	—	—	—
Hypertension	Vascular disorders	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—

Most-reported serious reactions: Asthma, Pneumonia, Bronchitis, Ischaemic stroke, Depression, Angina unstable, Myocardial infarction, Pancreatitis acute.

Data from ClinicalTrials.gov NCT03052517 adverse events section.

Sponsor's own description

This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Fevipiprant in the treatment of asthma.
White C, Wright A, Brightling C. · · 2018 · cited 22× · PMID 29363343 · DOI 10.1080/13543784.2018.1432592
Spotlight on fevipiprant and its potential in the treatment of asthma: evidence to date.
Kao CC, Parulekar AD. · · 2019 · cited 14× · PMID 30662272 · DOI 10.2147/jaa.s167973
Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial.
Maspero J, Agache IO, Kamei T, Yoshida M, et al · · 2021 · cited 5× · PMID 34895218 · DOI 10.1186/s12931-021-01904-8

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03052517 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 12 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03052517.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing