A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia

ID#: NCT07623200

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: September 08, 2026

End Date: November 01, 2030

Contact Information:
Incyte Corporation Call Center (US)
1.855.463.3463
Incyte Corporation Call Center (ex-US)
+800 00027423
Summary: This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.
Eligibility:

Inclusion Criteria:

- Confirmed diagnosis of high-risk ET.

- Presence of mutCALR.

- Prior treatment with at least 1 cytoreductive therapy.

Exclusion Criteria:

- Presence of any hematologic malignancy other than ET.

- Major bleeding or thrombosis within the last 3 months prior to study enrollment.

- Any prior allogenic or autologous stem-cell transplantation.

- Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.

- Prior nonhematologic malignancy except for the following: Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening. Adequately treated carcinoma in situ without current evidence of disease. Other protocol-defined Inclusion/Exclusion Criteria apply.