Drugs / Ligelizumab
Trials 19
| 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 · 1 met primary · 1 missed | ||||||
| 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 | Met primary |
| 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 | Missed primary |
| 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| Phase 2 | NCT01451450 | — | food allergy | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |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 · 2 met primary | ||||||
| Phase 3 | NCT05678959 | Apr 2023 → Mar 2025 | food allergy | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| 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 Stop: Business |
| 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 | Met primary |
| Phase 3 | NCT03580369 | Oct 2018 → Jul 2021 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| — | NCT04903613 Background | — | chronic idiopathic urticaria | Novartis Pharmaceuticals | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2021-12-20 | Novartis Pharmaceuticals | Results Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU) novartis.com ↗ |
| 2021-09-29 | Novartis Pharmaceuticals | Results Novartis data show achieving complete control of chronic spontaneous urticaria (CSU) improves overall quality of life, as reported by patients novartis.com ↗
Complete control of CSU symptoms, assessed by a composite of patient reported outcomes (PROs), is more likely to be achieved and sustained with ligelizumab than Xolair ® (omalizumab) or placebo 2 |
| 2021-01-14 | Novartis Pharmaceuticals | Regulatory Novartis ligelizumab (QGE031) receives FDA Breakthrough Therapy designation for patients with chronic spontaneous urticaria (CSU) novartis.com ↗
Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria (CSU) in patients with an inadequate response to H1-antihistamines |
| 2020-01-09 | Novartis Pharmaceuticals | Results Novartis ligelizumab (QGE031) more effective than Xolair® at inhibiting immunoglobulin E pathway responsible for chronic spontaneous urticaria novartis.com ↗
Novartis, a leader in immuno-dermatology, announced mechanistic study results showing ligelizumab is more effective at inhibiting the major pathogenic IgE/FcεRI pathway in chronic spontaneous urticaria (CSU), than current therapy Xolair ® (omalizumab) 1 . |
| 2019-10-08 | Novartis Pharmaceuticals | Results Novartis data show more patients are completely symptom-free from chronic spontaneous urticaria with ligelizumab (QGE031) than Xolair® 300 mg novartis.com ↗
Results from a Phase IIb dose-finding study show an average complete response rate of 42% for doses 240 mg and 72 mg ligelizumab at Week 12 compared with 26% for those taking 300 mg Xolair’s dose (omalizumab)[1] |
| 2018-12-04 | Novartis Pharmaceuticals | Results Novartis advances ligelizumab (QGE031) in urticaria to Phase III on basis of strong Phase II head-to-head data novartis.com ↗
Results from the placebo- and active-controlled Phase IIb trial showed that ligelizumab met the primary endpoint by demonstrating a clear dose-response relationship, and improvements over Xolair ® (omalizumab) in CSU patients[4]. |
All press releases naming this drug 6 releases
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 NCT03907878 ↗ |
| 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 ↗ |