8 completed, 5 terminated, 1 no longer available, 1 withdrawn. 10 Phase 2, 3 Phase 3, 2 Phase 1.
By phase and status
Follow QGE031: new trials by email Literature Review of QGE031 trials Research Report on QGE031
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 |
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 | 39 | 2021-11-16 | 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 | 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 | 66 | 2019-04-13 | 2025-03-06 |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | | | 2012-07-23 |
Global Managed Access Program Cohort for Ligelizumab in CSU Ligelizumab - Chronic Spontaneous Urticaria | | No longer available | | | 2022-05-11 |
Conditions studied
Chronic Urticaria (6) · Asthma (5) · Urticaria (4) · Hypersensitivity (3) · Bronchiolitis Obliterans Syndrome (2) · Dermatitis, Atopic (2) · Skin Diseases (2) · Chronic Inducible Urticaria (1) · Cold Urticaria (1) · Epilepsy, Idiopathic Generalized (1) · Familial dermographism (1) · Peanut Hypersensitivity (1) · Pemphigoid, Bullous (1) · Pruritus (1)
Sponsors
Novartis Pharmaceuticals (15)
Countries
Germany (9) · Canada (8) · United States (8) · Japan (7) · Russia (7) · France (6) · Hungary (6) · Taiwan (6) · Slovakia (5) · Spain (5) · Turkey (Türkiye) (5) · United Kingdom (5) · Argentina (4) · Australia (4) · Greece (4)
Results publications
PMID 34773261, PMID 36440464, PMID 31577874, PMID 37492920
NIH funding
2014 (2), 2015 (1), 2017 (1), 2019 (1)