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NCT04244006: NS-DUPI
A Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome
Phase 2, PHASE3 trial testing Dupilumab Prefilled Syringe in Netherton Syndrome in 24 participants. Status unknown.
1 June 2024
Quick facts
| Lead sponsor | University Hospital, Toulouse |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 23 July 2020 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 June 2024 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Dupilumab Prefilled Syringe — full drug profile →
- Placebo Prefilled Syringe
Conditions studied
- Netherton Syndrome — all drugs for Netherton Syndrome →
Sponsor
University Hospital, Toulouse
Who can join
18 and older, any sex, with Netherton Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To date, there are no effective therapy for the management of Netherton Syndrome (NS) Patients use emollients with a limited efficacy on scaling and no efficacy on skin inflammation and pruritus. They may also use topical corticosteroids or calcineurin inhibitors in case of eczematous lesions. The use of therapies targeting skin inflammation has been reported in a few case reports. Their efficacy is very limited and their uses are limited because of the chronicity of the disease, the impaired skin barrier function and the risk for skin infections and skin cancers. Therefore, there is a huge medical need for novel therapies in NS.The expected consequences of this study are that a 16-week course of dupilumab will be more effective than placebo for the treatment of moderate to severe NS Dupilumab could therefore improve skin condition and quality of life.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dupilumab in Inflammatory Skin Diseases: A Systematic Review.
Olbrich H, Sadik CD, Ludwig RJ, Thaçi D, et al · · 2023 · cited 67× · PMID 37189381 · DOI 10.3390/biom13040634 -
New developments in the molecular treatment of ichthyosis: review of the literature.
Joosten MDW, Clabbers JMK, Jonca N, Mazereeuw-Hautier J, et al · · 2022 · cited 38× · PMID 35840979 · DOI 10.1186/s13023-022-02430-6 -
Treatment Experiences with Intravenous Immunoglobulins, Ixekizumab, Dupilumab, and Anakinra in Netherton Syndrome: A Case Series.
Ragamin A, Nouwen AEM, Dalm VASH, van Mierlo MMF, et al · · 2023 · cited 19× · PMID 35998563 · DOI 10.1159/000525987 -
Challenges in Treating Genodermatoses: New Therapies at the Horizon.
Morren MA, Legius E, Giuliano F, Hadj-Rabia S, et al · · 2021 · cited 10× · PMID 35069188 · DOI 10.3389/fphar.2021.746664 -
Clinical Measurement of Transepidermal Water Loss.
Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148 -
Biologics and Small-Molecule Therapies in Netherton Syndrome: A Comprehensive Review.
Morizane S, Mukai T, Sunagawa K, Hasui KI, et al · · 2025 · PMID 40888388 · DOI 10.1111/1346-8138.17923
Verify or expand the search:
- PubMed search for NCT04244006
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dupilumab Prefilled Syringe
Trials testing the same drug.
- NCT05094570 — Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP · Phase 4 · recruiting
- NCT04358224 — The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment · Phase 4 · completed
Other recruiting trials for Netherton Syndrome
Currently open trials in the same condition.
- NCT06137157 — Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome · Phase 1 · recruiting
- NCT05789056 — Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome · Phase 2, PHASE3 · recruiting
- NCT05521438 — Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome · Phase 2, PHASE3 · active not recruiting
Other University Hospital, Toulouse trials
Trials by the same sponsor.
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- NCT07524088 — Contamination of Young Children Hair During Acute Cannabis Intoxication · NA · not yet recruiting
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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 NCT04244006 (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 University Hospital, Toulouse
- Last refreshed: 23 August 2023
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/NCT04244006.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing