Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Obexelimab · 4 trials · 4 indications
Proportion of participants with hemoglobin (Hgb) ≥ 10 g/dL and ≥ 2 g/dL increase from Baseline with no use of blood transfusion or glucocorticoid (GC) rescue therapy.
Proportion of participants who achieve a durable Hgb response (defined as Hgb ≥ 10 g/dL and ≥ 2 g/dL increase from Baseline on at least 3 of 4 consecutive available visits), at the earliest on or after Week 12, with no use of blood transfusion or GC rescue therapy prior to attaining durable response through Week 24.
Time to first IgG4-RD flare, defined as the reappearance of previous signs/symptoms or appearance of new signs/symptoms of IgG4-RD that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC), from randomization to Week 52.
Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI
| Arm | Type | Description |
|---|---|---|
| Safety and Dose Confirmation Run-in Period (SRP): Obexelimab | EXPERIMENTAL | Obexelimab will be administered as an SC injection for 24 weeks. |
| Randomized Control Period (RCP): Obexelimab | EXPERIMENTAL | Obexelimab will be administered as an SC injection for 24 weeks. |
| Randomized Control Period (RCP): Placebo | PLACEBO_COMPARATOR | Placebo will be administered as an SC injection for 24 weeks |
| ZB012 | EXPERIMENTAL | Obexelimab administered as an SC injection. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered as an SC injection. |
| Obexelimab | EXPERIMENTAL | Obexelimab will be administered as a subcutaneous injection for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Obexelimab | DRUG | Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity. |
| Placebo | OTHER | Placebo |
Inclusion Criteria: 1. Males and females, ≥ 18 years of age 2. Clinically diagnosed with wAIHA for at least 3 months and currently receiving treatment for wAIHA or have previously received treatment for wAIHA. 3. Diagnosis of primary or secondary wAIHA documented by a positive direct antiglobulin t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Ianalumab |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE3 | Obexelimab |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE3 | Fostamatinib disodium |
| Johnson & Johnson | JNJ | 1 | PHASE2 | M281 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | rilzabrutinib |
| HUTCHMED (China) Limited Sponsored ADR | HCM | 1 | PHASE2 | HMPL-523 |
| Vertex Pharmaceuticals Incorporated | VRTX | 1 | PHASE1 | povetacicept |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX112 |