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Ligelizumab · 5 trials · 1 indication
Participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) summary for entire study (64 weeks) An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement
The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest.
| Arm | Type | Description |
|---|---|---|
| Ligelizumab 120 mg per 1 mL qw4 | EXPERIMENTAL | Subjects received one subcutaneous injection every 4 weeks at 13 visits during the treatment period |
| Ligelizumab 120 mg | EXPERIMENTAL | Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w |
| Ligelizumab 72 mg | EXPERIMENTAL | Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w |
| Omalizumab 300 mg | ACTIVE_COMPARATOR | Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w |
| Placebo | PLACEBO_COMPARATOR | Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48 |
| Ligelizumab 24 mg | EXPERIMENTAL | Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive). |
| Placebo + Ligelizumab 120 mg | PLACEBO_COMPARATOR | Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial. |
| Ligelizumab | EXPERIMENTAL | QGE031 240 mg s.c. q4w x 13 treatments |
| Name | Type | Description |
|---|---|---|
| Ligelizumab | BIOLOGICAL | Liquid in vial |
| Omalizumab | BIOLOGICAL | Lyophilized powder for solution in vial |
| Placebo | OTHER | Liquid in vial |
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study * Male and female subjects ≥ 18 years of age at the time of screening * CSU diagnosis for ≥ 6 months * Diagnosis of CSU refractory to H1-AH at approved doses at the time of Baseline (Visit 110, Da...
Ligelizumab is an investigational drug being developed for chronic spontaneous urticaria (CSU), a skin condition characterized by recurrent hives. It is being studied in patients whose symptoms are inadequately controlled with H1-antihistamines. The drug is in Phase 3 clinical development and has not been approved by regulatory authorities.
Ligelizumab is a small molecule that targets and inhibits the activity of immunoglobulin E (IgE), a key driver of allergic responses. By binding to IgE, it prevents the activation of mast cells and basophils, which are immune cells that release histamine and cause hives in chronic spontaneous urticaria.
Ligelizumab is being developed by Novartis AG, a global pharmaceutical company headquartered in Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The company has conducted multiple clinical trials to evaluate the drug's safety and efficacy in chronic spontaneous urticaria.
Ligelizumab is in Phase 3 clinical development for chronic spontaneous urticaria. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 3 program includes studies in adults and adolescents whose symptoms are not adequately controlled with H1-antihistamines.
Ligelizumab has been studied in five completed clinical trials, including Phase 2 and Phase 3 studies. Key trials include NCT03580369, a Phase 3 study in adolescents and adults with CSU, and NCT03907878, a Phase 3 study in Japanese patients. Other trials include NCT02649218 and NCT03437278, which evaluated long-term safety and use in adolescents.
Yes, Ligelizumab is also known as QGE031. In earlier clinical trials, the drug was referred to by this code name. For example, NCT02649218 and NCT03437278 both use the QGE031 designation in their titles, while later Phase 3 studies use the name Ligelizumab.