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QGE031 · 5 trials · 5 indications
The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks). Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 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) To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.
The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - \> 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - \< 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
Efficacy response will be assessed using EASI.
Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs and other safety assessments.
| Arm | Type | Description |
|---|---|---|
| QGE031 24 mg s.c. q4w | EXPERIMENTAL | ligelizumab 24 mg injection subcutaneous every 4 weeks |
| QGE031 72 mg s.c. q4w | EXPERIMENTAL | ligelizumab 72 mg injection subcutaneous every 4 weeks |
| QGE031 240 mg s.c. q4w | EXPERIMENTAL | ligelizumab 240 mg injection subcutaneous every 4 weeks |
| Omalizumab 300 mg s.c. q4w | ACTIVE_COMPARATOR | omalizumab 300 mg injection subcutaneous every 4 weeks |
| Placebo s.c. q4w | PLACEBO_COMPARATOR | placebo injection subcutaneous every 4 weeks |
| QGE031 120 mg s.c. s.d. | EXPERIMENTAL | ligelizumab 120 mg injection subcutaneous single dose |
| QGE031 240 mg every 2 weeks (q2w) | EXPERIMENTAL | Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks. |
| QGE031 240 mg q4w | EXPERIMENTAL | Participants received QGE031 240 mg s.c. q4w for 16 weeks. |
| QGE031 180 mg q2w | EXPERIMENTAL | Participants received QGE031 180 mg s.c. q2w for 16 weeks. |
| QGE031 120 mg q2w | EXPERIMENTAL | Participants received QGE031 120 mg s.c. q2w for 16 weeks. |
| QGE031 36 mg q2w | EXPERIMENTAL | Participants received QGE031 36 mg s.c. q2w for 16 weeks. |
| QGE031 12 mg q2w | EXPERIMENTAL | Participants received QGE031 12 mg s.c. q2w for 16 weeks. |
| Omalizumab (as per locally approved dosing table) | ACTIVE_COMPARATOR | Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks. |
| Placebo to QGE031 240 mg q2w | PLACEBO_COMPARATOR | Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 240 mg q4w | PLACEBO_COMPARATOR | Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 180 mg q2w | PLACEBO_COMPARATOR | Participants received QGE031 180 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 120 mg q2w | PLACEBO_COMPARATOR | Participants received QGE031 120 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 36 mg q2w | PLACEBO_COMPARATOR | Participants received QGE031 36 mg s.c. q2w for 16 weeks. |
| Placebo to QGE031 12 mg q2w | PLACEBO_COMPARATOR | Participants received QGE031 12 mg s.c. q2w for 16 weeks. |
| Placebo to omalizumab | PLACEBO_COMPARATOR | Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks. |
| Group 1 QGE031 | EXPERIMENTAL | QGE031 will be administered as a subcutaneous dose q2 weeks |
| Group 2 Placebo | PLACEBO_COMPARATOR | A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks |
| Group 3 Cyclosporine A | EXPERIMENTAL | Cyclosporine A will be administered (as per label) for atopic dermatitis. |
| QGE031 | EXPERIMENTAL | During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). Three dose levels of QGE031 will be offered during the study: low, medium, and high. Participants will be randomized to receive one of these dose levels for all dosing visits. |
| omalizumab | ACTIVE_COMPARATOR | During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses) or once every four weeks (total of three doses). The dose that a participant receives will depend upon the participant's body weight and IgE level; dosage will be determined based upon local omalizumab dosing charts. |
| placebo | PLACEBO_COMPARATOR | During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). |
| QGE031 Dose 1 | EXPERIMENTAL | QGE031 Dose 1: subcutaneous injection, single dose |
| QGE031 Dose 2 | EXPERIMENTAL | QGE031 Dose 2: subcutaneous injection, single dose |
| QGE031 Dose 3 | EXPERIMENTAL | QGE031 Dose 3: subcutaneous injection, single dose |
| Name | Type | Description |
|---|---|---|
| QGE031 | BIOLOGICAL | - |
| Omalizumab | BIOLOGICAL | - |
| Placebo | OTHER | - |
| Cyclosporine A | DRUG | - |
Inclusion Criteria: * Diagnosis of chronic spontaneous urticaria for at least 6 months * Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization Exclusion Criteria: * Clearly defined underlying etiology for chronic urticaria other than chronic spontaneou...
QGE031 is an investigational drug being studied for chronic spontaneous urticaria, asthma, allergic asthma, allergy, and atopic dermatitis. It is being developed by Novartis AG for respiratory and allergic conditions. As of now, QGE031 is in clinical development and has not been approved by regulatory authorities.
QGE031 is a small molecule being developed by Novartis AG. The specific molecular target of QGE031 has not been disclosed in available information. It is being studied for conditions such as asthma, allergic asthma, allergy, atopic dermatitis, and chronic spontaneous urticaria.
QGE031 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of QGE031 in various allergic and respiratory conditions.
QGE031 is in Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Clinical trials are ongoing to evaluate its safety and efficacy for conditions like asthma, allergic asthma, and atopic dermatitis.
QGE031 has been studied in several clinical trials, including NCT01552629 for atopic dermatitis, NCT01596712 for allergy in Japanese subjects, NCT01703312 for allergic asthma, and NCT01716754 for asthma. These trials have been completed and involved a total of 471 participants.
QGE031 is not the same as omalizumab. In clinical trials, QGE031 has been compared to omalizumab to evaluate its efficacy. For example, NCT01703312 compared QGE031 to omalizumab in patients with allergic asthma, and NCT01716754 compared QGE031 to placebo and omalizumab in asthma patients.