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NCT04513548: MASTER
Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria
Phase 1 trial testing Ligelizumab in Chronic Spontaneous Urticaria in 11 participants. Terminated before completion.
19 July 2022
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 11 |
| Start date | 5 August 2020 |
| Primary completion | 19 July 2022 |
| Estimated completion | 19 July 2022 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Ligelizumab — full drug profile →
- Placebo
Conditions studied
- Chronic Spontaneous Urticaria — all drugs for Chronic Spontaneous Urticaria →
- Cholinergic Urticaria — all drugs for Cholinergic Urticaria →
- Cold Urticaria — all drugs for Cold Urticaria →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 79, any sex, with Chronic Spontaneous Urticaria or Cholinergic Urticaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to investigate the mechanism of action for ligelizumab (QGE031) treatment in patients with chronic urticaria. The study has two parts. The study population will consist of approximately 68 male and female healthy volunteers and patients. In Part 1, approximately 20 healthy volunteers and patients with chornic urticaria will be enrolled. In Part 2 approximately 48 patients with chronic urticaria (spontaneous chronic urticaria, cholinergic urticaria or cold urticaria). Part 1 consists of a screening period up 2 weeks and a visit with skin tests; there is no treatment taken in Part 1. Part 2 is randomized, subject, investigator and sponsor blinded. It consists of a screening period up to 4 weeks, a 16 week treatment period and a 12-week follow-up period after last treatment. A follow-up call at Week 32 will be performed via telephone.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The rationale for development of ligelizumab in food allergy.
Wood RA, Chinthrajah RS, Eggel A, Bottoli I, et al · · 2022 · cited 30× · PMID 36185545 · DOI 10.1016/j.waojou.2022.100690 -
Human Lung Mast Cells: Therapeutic Implications in Asthma.
Poto R, Criscuolo G, Marone G, Brightling CE, et al · · 2022 · cited 26× · PMID 36430941 · DOI 10.3390/ijms232214466 -
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 -
Monoclonal Antibodies in Treating Chronic Spontaneous Urticaria: New Drugs for an Old Disease.
Manti S, Giallongo A, Papale M, Parisi GF, et al · · 2022 · cited 7× · PMID 35956071 · DOI 10.3390/jcm11154453
Verify or expand the search:
- PubMed search for NCT04513548
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ligelizumab
Trials testing the same drug.
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- NCT04210843 — Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study Wit · Phase 3 · terminated
- NCT03907878 — A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- · Phase 3 · completed
- NCT03580356 — A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controll · Phase 3 · completed
- NCT03580369 — A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately C · Phase 3 · completed
Other recruiting trials for Chronic Spontaneous Urticaria
Currently open trials in the same condition.
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- NCT07358780 — Remibrutinib in Real-world Clinical Practice - a US Sub-study · recruiting
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Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT04513548 (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: 18 June 2024
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/NCT04513548.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing