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

A Phase 3, Randomized, Open-Label Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia and a CALR Mutation Previously Treated With Cytoreductive Therapy (EXCALIBUR-ET2)

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• INCA033989 (drug)
• Best Available Treatment (drug)

Sponsor: Incyte Corporation · Participants: 426 · Started: Sep 8, 2026

Contact the study team

• Incyte Corporation Call Center (US) · Phone: 1.855.463.3463
• Incyte Corporation Call Center (ex-US) · Phone: +800 00027423

Official record on ClinicalTrials.gov — NCT07623200

Locations in the U.S.

Conditions

• Essential Thrombocythemia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.