10 completed, 8 terminated, 1 no longer available, 1 withdrawn. 10 Phase 2, 7 Phase 3, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 6, Terminated 3, Withdrawn 1 |
| Phase 3 | 7 | Terminated 4, Completed 3 |
| Phase 1 | 3 | Completed 2, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Long-term Extension Study of Ligelizumab in Food Allergy Ligelizumab 120 mg, Ligelizumab 240 mg - Food Allergy | Phase 3 | Terminated | Novartis Pharmaceuticals | 163 | 2023-04-27 | 2026-01-13 |
| Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy ligelizumab, Placebo - Allergy, Peanut | Phase 3 | Terminated | Novartis Pharmaceuticals | 211 | 2021-12-07 | 2025-04-29 |
| Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines Ligelizumab, Placebo - Chronic Inducible Urticaria | Phase 3 | Terminated | Novartis Pharmaceuticals | 39 | 2021-11-16 | 2024-06-18 |
| Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria Ligelizumab, Placebo - Chronic Spontaneous Urticaria, Cholinergic Urticaria | Phase 1 | Terminated | Novartis Pharmaceuticals | 11 | 2020-08-05 | 2024-06-18 |
| Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab Ligelizumab - Chronic Spontaneous Urticaria | Phase 3 | Terminated | Novartis Pharmaceuticals | 1033 | 2020-04-08 | 2024-06-20 |
| A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines Ligelizumab - Chronic Spontaneous Urticaria | Phase 3 | Completed | Novartis Pharmaceuticals | 66 | 2019-04-13 | 2025-03-06 |
| A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Ligelizumab, Omalizumab, Placebo - Chronic Spontaneous Urticaria | Phase 3 | Completed | Novartis Pharmaceuticals | 1078 | 2018-10-20 | 2025-01-07 |
| A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines Ligelizumab, Omalizumab, Placebo - Chronic Spontaneous Urticaria | Phase 3 | Completed | Novartis Pharmaceuticals | 1072 | 2018-10-17 | 2023-07-24 |
| Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU) Ligelizumab, Placebo - Chronic Spontaneous Urticaria | Phase 2 | Completed | Novartis Pharmaceuticals | 49 | 2018-08-01 | 2026-01-13 |
| A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients Ligelizumab - Chronic Spontaneous Urticaria | Phase 2 | Completed | Novartis Pharmaceuticals | 226 | 2016-05-24 | 2021-10-11 |
| Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma QGE031, Placebo - Asthma | Phase 2 | Terminated | Novartis Pharmaceuticals | 10 | 2015-09-01 | 2017-08-11 |
| Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU QGE031, Omalizumab, Placebo - Chronic Spontaneous Urticaria | Phase 2 | Completed | Novartis Pharmaceuticals | 382 | 2015-07-15 | 2021-01-05 |
| Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201 QGE031 - Asthma | Phase 2 | Terminated | Novartis Pharmaceuticals | 270 | 2014-03-27 | 2017-08-11 |
| Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment QGE031, Placebo - Bullous Pemphigoid | Phase 2 | Terminated | Novartis Pharmaceuticals | 20 | 2013-01-01 | 2016-04-28 |
| Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma QGE031, Omalizumab, Placebo - Asthma | Phase 2 | Completed | Novartis Pharmaceuticals | 471 | 2012-12-01 | 2017-08-11 |
| A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma QGE031, omalizumab, placebo - Allergic Asthma | Phase 1 / Phase 2 | Completed | Novartis Pharmaceuticals | 37 | 2012-11-01 | 2016-04-20 |
| A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients QGE031, Placebo, Cyclosporine A - Atopic Dermatitis | Phase 2 | Completed | Novartis Pharmaceuticals | 22 | 2012-01-05 | 2017-02-23 |
| Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects QGE031, Placebo - Allergy | Phase 1 | Completed | Novartis Pharmaceuticals | 209 | 2011-03-01 | 2012-11-22 |
| Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy QGE031, Placebo - Peanut Allergy | Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2012-07-23 | ||
| Global Managed Access Program Cohort for Ligelizumab in CSU Ligelizumab - Chronic Spontaneous Urticaria | No longer available | Novartis Pharmaceuticals | 2022-05-11 |
Chronic Urticaria (9) · Asthma (5) · Urticaria (4) · Hypersensitivity (3) · Peanut Hypersensitivity (3) · Bronchiolitis Obliterans Syndrome (2) · Chronic Inducible Urticaria (2) · Cold Urticaria (2) · Dermatitis, Atopic (2) · Food Hypersensitivity (2) · Skin Diseases (2) · Epilepsy, Idiopathic Generalized (1) · Familial dermographism (1) · Pemphigoid, Bullous (1) · Pruritus (1)
Germany (14) · United States (12) · Canada (11) · France (10) · Japan (10) · Russia (9) · Spain (9) · Australia (7) · Hungary (7) · Italy (7) · Taiwan (7) · Argentina (6) · Slovakia (6) · Turkey (Türkiye) (6) · United Kingdom (6)
PMID 34773261, PMID 36440464, PMID 38008109, PMID 31577874, PMID 37492920, PMID 38814736
2014 (2), 2018 (2), 2019 (2), 2015 (1), 2017 (1)