Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quilizumab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Quilizumab | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Two administrations by subcutaneous injection |
| Quilizumab | DRUG | Two administrations by subcutaneous injection |
Inclusion Criteria: * Diagnosis of CSU refractory to H1 antihistamines with/without LTRAs, as defined by the following: * The presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment despite use of H1 antihistamines during this time period * UAS7 score greater than 16 a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 10 | PHASE3 | LOU064 |
| Celldex Therapeutics, Inc. | CLDX | 4 | PHASE3 | barzolvolimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| ARS Pharmaceuticals, Inc. | SPRY | 1 | PHASE2 | epinephrine |
| Blueprint Medicines Corporation | BPMC | 1 | PHASE2 | BLU-808 |
| Azitra Inc | AZTR | 1 | PHASE1 | ATR04-484, Vehicle |
| BeOne Medicines Ltd. Sponsored ADR | ONC | 1 | PHASE1 | BGB-16673 |
| Enanta Pharmaceuticals, Inc. | ENTA | 1 | PHASE1 | EDP-978 |
Quilizumab is an investigational small molecule being studied for the treatment of urticaria, specifically refractory chronic spontaneous urticaria. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.
Quilizumab is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with refractory chronic spontaneous urticaria.
Quilizumab is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is still being studied for its potential use in treating urticaria.
Quilizumab has one completed Phase 2 clinical trial, identified as NCT01987947. This randomized, double-blind, placebo-controlled study enrolled 32 participants with refractory chronic spontaneous urticaria and was conducted in Canada and Germany.
Quilizumab is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for urticaria. The completed clinical trial, NCT01987947, was a Phase 2 study, but the drug has not yet received marketing authorization.