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 | 12 | PHASE3 | Remibrutinib, Omalizumab |
| 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 |
| BeOne Medicines Ltd. Sponsored ADR | ONC | 1 | PHASE1 | Tacabrutideg |
| Enanta Pharmaceuticals, Inc. | ENTA | 1 | PHASE1 | EDP-978 |
Quilizumab was studied for the treatment of refractory chronic spontaneous urticaria, a form of chronic hives that does not respond adequately to standard therapy. It was evaluated in a Phase 2 clinical trial in adults with this condition. It is an investigational monoclonal antibody and is not an approved treatment.
Quilizumab targets immunoglobulin E, also known as IgE, and acts as an inhibitor of this target. By binding to IgE, the antibody is designed to interfere with the IgE pathway that drives allergic and urticarial responses. IgE is the molecular target of the drug.
Quilizumab is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical evaluation of the drug in chronic spontaneous urticaria. The asset is a monoclonal antibody in the dermatology therapeutic area.
Quilizumab is in Phase 2 development. It has not been approved by the FDA and remains an investigational agent. The Phase 2 program in refractory chronic spontaneous urticaria has been completed, with no trials currently active.
Quilizumab was evaluated in one completed Phase 2 trial, NCT01987947, titled A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria. The trial enrolled 32 adults across Canada and Germany and was randomized, double blind, and placebo controlled.