Drugs / Ligelizumab
Trials 19 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04513548 | Aug 2020 → Jul 2022 | cholinergic urticaria, chronic urticaria, cold urticaria | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT01596712 | Mar 2011 → Aug 2012 | allergic disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01703312 | Nov 2012 → Oct 2013 | allergic asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT03437278 | Aug 2018 → Oct 2020 | chronic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02649218 | May 2016 → May 2019 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02336425 | Sep 2015 → Mar 2016 | asthma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02477332 | Jul 2015 → Nov 2016 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02075008 | Mar 2014 → Mar 2016 | asthma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01688882 | Jan 2013 → Mar 2015 | bullous pemphigoid | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01716754 | Dec 2012 → Jan 2016 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01552629 | Jan 2012 → Aug 2013 | atopic eczema | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01451450 | — | food allergy | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT05678959 | Apr 2023 → Mar 2025 | food allergy | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT04984876 | Dec 2021 → Nov 2023 | food allergy | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT05024058 | Nov 2021 → Aug 2022 | chronic inducible urticaria | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT04210843 | Apr 2020 → Sep 2022 | chronic urticaria | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT03907878 | Apr 2019 → Jan 2022 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03580356 | Oct 2018 → Jun 2021 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03580369 | Oct 2018 → Jul 2021 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT04903613 Background | — | chronic idiopathic urticaria | Novartis Pharmaceuticals | No longer available | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-12-20 | Novartis Pharmaceuticals | Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU) novartis.com ↗ |
| 2021-01-14 | Novartis Pharmaceuticals | Novartis ligelizumab (QGE031) receives FDA Breakthrough Therapy designation for patients with chronic spontaneous urticaria (CSU) novartis.com ↗ |
| 2020-01-09 | Novartis Pharmaceuticals | Novartis ligelizumab (QGE031) more effective than Xolair® at inhibiting immunoglobulin E pathway responsible for chronic spontaneous urticaria novartis.com ↗ |
| 2019-10-08 | Novartis Pharmaceuticals | Novartis data show more patients are completely symptom-free from chronic spontaneous urticaria with ligelizumab (QGE031) than Xolair® 300 mg novartis.com ↗ |
| 2018-12-04 | Novartis Pharmaceuticals | Novartis advances ligelizumab (QGE031) in urticaria to Phase III on basis of strong Phase II head-to-head data novartis.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ligelizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04513548 ↗ |
| Known as | QGE031 | “A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic...” NCT03580369 ↗11“A Multi-center, Open-label Study to Investigate the Safety/Tolerability and Efficacy of Ligelizumab (QGE031) in the Treatment of Adult Japanese Patients With Chronic...” NCT03907878 ↗ “Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria” NCT04513548 ↗ |
| Action | Inhibit | “Ig epsilon chain C region inhibitor” CHEMBL2109457 ↗1“anti-immunoglobulin E (IgE)” PMID 34773261 ↗ Nov 2021 |
| Modality | Monoclonal antibody | “a next-generation, humanized anti-immunoglobulin E (IgE) monoclonal antibody” PMID 34773261 ↗ Nov 2021 |
| Route | Subcutaneous | “QGE031 liquid for subcutaneous injection.” NCT01451450 ↗ |
| Target | IGHE | “Ig epsilon chain C region inhibitor” CHEMBL2109457 ↗ |