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NCT03782532
Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma
Phase 3 trial testing Dupilumab SAR231893 in Asthma in 486 participants. Completed in 21 May 2022.
21 May 2022
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 486 |
| Start date | 25 January 2019 |
| Primary completion | 21 May 2022 |
| Estimated completion | 21 May 2022 |
| Sites | 67 locations across China, India |
Drugs / interventions tested
- Dupilumab SAR231893
- Placebo
- Asthma Controller Therapies (include prednisone/prednisolone) — full drug profile →
- Asthma Reliever Therapies — full drug profile →
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Sanofi — full company profile →
Who can join
12 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objective: To evaluate the efficacy of dupilumab in patients with persistent asthma Secondary Objectives: * To evaluate the safety and tolerability of dupilumab * To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life * To evaluate dupilumab systemic exposure and immunogenicity
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Novel Approaches in the Inhibition of IgE-Induced Mast Cell Reactivity in Food Allergy.
Tontini C, Bulfone-Paus S. · · 2021 · cited 24× · PMID 34456900 · DOI 10.3389/fimmu.2021.613461 -
Anti-interleukin-13 and anti-interleukin-4 agents versus placebo, anti-interleukin-5 or anti-immunoglobulin-E agents, for people with asthma.
Gallagher A, Edwards M, Nair P, Drew S, et al · · 2021 · cited 19× · PMID 34664263 · DOI 10.1002/14651858.cd012929.pub2 -
Dupilumab in the Treatment of Moderate to Severe Asthma: An Evidence-Based Review.
Rathinam KK, Abraham JJ, Vijayakumar TM. · · 2019 · cited 14× · PMID 31871508 · DOI 10.1016/j.curtheres.2019.100571 -
Dupilumab and tezepelumab in severe refractory asthma: new opportunities.
Ragnoli B, Morjaria J, Pignatti P, Montuschi P, et al · · 2022 · cited 7× · PMID 35655942 · DOI 10.1177/20406223221097327 -
Dupilumab Efficacy and Safety in Patients With Persistent Asthma: Asia-Pacific Region.
Zhang Q, Zhong N, Dhooria S, Fu X, et al · · 2025 · cited 2× · PMID 39988927 · DOI 10.1111/cea.70005 -
Biologics to Treat Severe Asthma in Children and Adolescents: A Practical Update.
Marseglia GL, Licari A, Tosca MA, Ciprandi G. · · 2020 · cited 2× · PMID 35921565 · DOI 10.1089/ped.2020.1212
Verify or expand the search:
- PubMed search for NCT03782532
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dupilumab SAR231893
Trials testing the same drug.
- NCT05049122 — Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52) · Phase 4 · completed
- NCT04718870 — Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis · Phase 4 · completed
- NCT04678882 — Dupilumab in Japanese Patients With Atopic Dermatitis · Phase 3 · completed
- NCT04681729 — Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 · Phase 3 · completed
- NCT04678856 — Dupilumab in CRSsNP · 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
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- 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 Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
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 NCT03782532 (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 Sanofi
- Last refreshed: 28 December 2022
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/NCT03782532.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing