Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IGE025 · 1 trial · 1 indication
Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
| Arm | Type | Description |
|---|---|---|
| IGE025 | EXPERIMENTAL | Patients will receive omalizumab administered subcutaneously every 4 weeks at the study center. |
| Placebo to IGE025 | PLACEBO_COMPARATOR | Placebo administered subcutaneously every 4 weeks at the study center. |
| Name | Type | Description |
|---|---|---|
| IGE025 | DRUG | Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial. |
| placebo | DRUG | Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial. |
Inclusion Criteria: * Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamines at Baseline Exclusion Criteria: * Clearly defined underlying etiology for chronic urticarias other than CIU (main manifestation being physical urticaria). This includes the following urticarias: Acute...
IGE025 is an investigational small molecule being developed for chronic idiopathic urticaria, a condition characterized by recurrent hives without an identifiable cause. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
IGE025 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for chronic idiopathic urticaria.
IGE025 is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 2 clinical trial for the drug has been completed, and it remains under evaluation for chronic idiopathic urticaria.
IGE025 has been studied in one completed Phase 2 clinical trial, identified as NCT01599637. This trial enrolled 40 participants with chronic idiopathic urticaria who had not responded to antihistamine treatment. The study was randomized, double-blind, and placebo-controlled, and was conducted in Germany.
IGE025 is not the same as omalizumab. Omalizumab is a biologic antibody, while IGE025 is a small molecule. The completed clinical trial NCT01599637 was a mode of action study of omalizumab in patients with chronic idiopathic urticaria, and IGE025 is a separate investigational drug.