Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05786573 | A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre) | PHASE3 | ACTIVE NOT_RECRUITING | 134 | — | — | Sep 25, 2023 | Aug 31, 2026 | Jun 25, 2025 | 7 | Italy, Poland +3 |
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.
| 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 |
| 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 |