Home › Essential Thrombocythemia › NCT07623200
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
RecruitingPhase 3
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
Full eligibility criteria
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
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.