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NCT03771040
A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib Versus Placebo in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
Phase 3 trial testing Masitinib in Asthma in 347 participants. Completed in 1 September 2020.
1 September 2020
Quick facts
| Lead sponsor | AB Science |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 347 |
| Start date | 1 December 2016 |
| Primary completion | 1 September 2020 |
| Estimated completion | 1 September 2020 |
| Sites | 5 locations across Argentina, Malaysia, Peru, Philippines, Ukraine |
Drugs / interventions tested
- Masitinib — full drug profile →
- Placebo
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
AB Science — full company profile →
Who can join
Adults 18 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Severe asthma exacerbation rate
Time frame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
The number of severe asthma exacerbations over time frame of outcome measure
Sponsor's own description
The purpose of this study is to assess the safety and efficacy of masitinib (6 mg/kg/day) in severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Eosinophilic Asthma: Pathophysiology and Therapeutic Horizons.
Hussain M, Liu G. · · 2024 · cited 60× · PMID 38474348 · DOI 10.3390/cells13050384 -
Kinase inhibitors in the treatment of obstructive pulmonary diseases.
Defnet AE, Hasday JD, Shapiro P. · · 2020 · cited 17× · PMID 32361678 · DOI 10.1016/j.coph.2020.03.005
Verify or expand the search:
- PubMed search for NCT03771040
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Masitinib
Trials testing the same drug.
- NCT00789633 — Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer · Phase 3 · completed
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 AB Science trials
Trials by the same sponsor.
- NCT07174492 — Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients · Phase 3 · not yet recruiting
- NCT05449444 — Masitinib for the Treatment of Severe Mast Cell Activation Syndrome · Phase 2 · unknown
- NCT05200169 — Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects · EARLY_PHASE1 · completed
- NCT00789633 — Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03771040 (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 AB Science
- Last refreshed: 7 December 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/NCT03771040.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing