Recruiting
Phase 3

INCA033989 vs. Best Available Therapy

Sponsor:

Incyte Corporation

Code:

NCT07623200

Conditions

Essential Thrombocythemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCA033989

Best Available Treatment

Study Details

Brief 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.

Conditions

Essential Thrombocythemia

Study ID

NCT07623200

Start date

Sep 8, 2026

Status verified date

Sep, 2026

Completion date

Nov 1, 2030

Anticipated

Primary completion date

Jun 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

426 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: INCA033989

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

experimental: Best Available Therapy (BAT)

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

Interventions

INCA033989

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

Best Available Treatment

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

Primary outcome measure

  • Durable clinicohematologic response (DCR) [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

Marin Cancer Care

Recruiting

Greenbrae, California, United States, 94904

More Information

Sponsor

Incyte Corporation

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • calreticulin (CALR)
  • mutCALR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.