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...
Obexelimab is an investigational drug being developed for IgG4-related disease, warm autoimmune hemolytic anemia, systemic lupus erythematosus, and relapsing multiple sclerosis. It is currently in clinical trials for these conditions and is not yet approved by regulatory authorities.
Obexelimab targets CD19 and FCGR2B, functioning as an inhibitor of these molecular targets. By engaging these proteins, the drug is designed to modulate B-cell activity, which is relevant to the autoimmune and inflammatory conditions it is being studied for.
Obexelimab is being developed by Zenas BioPharma, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ZBIO on the public markets.
Obexelimab is in Phase 3 clinical trials for IgG4-related disease and warm autoimmune hemolytic anemia, and in Phase 2 trials for systemic lupus erythematosus and relapsing multiple sclerosis. It is an investigational drug still in clinical development and has not been approved.
Obexelimab is being studied in multiple trials, including NCT05662241 for IgG4-related disease, NCT05786573 for warm autoimmune hemolytic anemia, NCT06559163 for systemic lupus erythematosus, and NCT06564311 for relapsing multiple sclerosis. All trials are active but not recruiting participants.
Obexelimab is the primary name for this investigational drug, and no alternative names have been reported. It is being studied under this name across all its clinical trials for various autoimmune conditions.