A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia (EXCALIBUR-ET2)

Incyte

Status and phase: Enrolling; Phase 3

Conditions: Essential Thrombocythemia

Treatments: Drug: Best Available Treatment; Drug: INCA033989

Study type: Interventional

Funder types: Industry

Identifiers

NCT07623200

2026-525398-38-00 (Registry Identifier)

INCA033989-304

Details and patient eligibility

About

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.

Enrollment: 426 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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426 participants in 2 patient groups

INCA033989

Experimental group

Description:

Administered intravenous (IV) in accordance with the protocol-defined requirements.

Treatment:

Drug: INCA033989

Best Available Therapy (BAT)

Experimental group

Description:

Best Available Therapy (BAT) will be selected by the investigator.

Treatment:

Drug: Best Available Treatment