Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCA000585 · 1 trial · 1 indication
Defined as any adverse event, either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug.
Defined as platelet count ≥ 50 × 109/L in the absence of clinically significant bleeding or rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary ITP.
Defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline in the absence of rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary wAIHA.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - primary immune thrombocytopenia (ITP) | EXPERIMENTAL | INCA000585 will be administered intravenously. |
| Cohort 2 - primary warm autoimmune hemolytic anemia (wAIHA) | EXPERIMENTAL | INCA000585 will be administered intravenously. |
| Name | Type | Description |
|---|---|---|
| INCA000585 | DRUG | Tafasitamab will be administered intravenously at protocol defined timepoints. |
Inclusion Criteria: \- Ability to comprehend and willingness to sign a written ICF for the study. * Aged ≥ 18 years. * Confirmed historical diagnosis of one of the following autoimmune blood disorders: * Primary ITP. * Primary wAIHA. * No history of splenectomy. * Confirmed transient response...
INCA000585 is an investigational small molecule being developed for the treatment of immune thrombocytopenia, a hematologic condition characterized by low platelet counts. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
INCA000585 is being developed by Incyte Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol INCY. The company is conducting a Phase 2 clinical trial to evaluate the drug in adult participants with primary autoimmune blood cell disorders.
INCA000585 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for any use. The ongoing Phase 2 trial is actively recruiting participants to assess the safety and tolerability of the drug.
INCA000585 is being studied in a Phase 2 clinical trial registered as NCT07104565. The trial is titled "Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders" and is currently recruiting participants with immune thrombocytopenia.
The Phase 2 trial of INCA000585, NCT07104565, has a planned enrollment of 56 participants. It is a controlled trial, though it is not randomized or double-blinded. The study is open to adults aged 18 years and older and is being conducted in the United States, Australia, France, Italy, Netherlands, Spain, and the United Kingdom.