NCT07623200

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
426

participants targeted

Target at P50-P75 for phase_3

Timeline
52mo left

Started Jul 2026

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2029

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2.9 years

First QC Date

May 29, 2026

Last Update Submit

June 5, 2026

Conditions

Essential Thrombocythemia

Keywords

calreticulin (CALR)mutCALR

Outcome Measures

Primary Outcomes (1)

  • Durable clinicohematologic response (DCR)

    Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.

    Week 24

Secondary Outcomes (12)

  • Reduction from baseline in calreticulin exon 9 frameshift mutation(s) (mutCLAR) variant allele frequency (VAF)

    Week 24

  • Durable clinicohematologic response (DCR)

    Week 48

  • Durable partial clinicohematologic response (DPR)

    Week 24

  • Durable partial clinicohematologic response (DPR)

    Week 48

  • Longest duration of complete hematologic response (CHR)

    Up to Week 48

  • +7 more secondary outcomes

Study Arms (2)

INCA033989

EXPERIMENTAL

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

Drug: INCA033989

Best Available Therapy (BAT)

EXPERIMENTAL

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

Drug: Best Available Treatment

Interventions

INCA033989DRUG

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

INCA033989
Best Available TreatmentDRUG

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

Also known as: BAT could include:, • HU, • ANA, • PEG interferon alfa-2a, • Ropeginterferon alfa-2b
Best Available Therapy (BAT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of high-risk ET.
  • Presence of mutCALR.
  • Prior treatment with at least 1 cytoreductive therapy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Thrombocythemia, Essential

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombocytosisBlood Platelet DisordersMyeloproliferative DisordersBone Marrow DiseasesHemorrhagic Disorders

Study Officials

  • Incyte Medical Monitor

    Incyte Corporation

    STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423eumedinfo@incyte.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2026

First Posted

June 3, 2026

Study Start (Estimated)

July 31, 2026

Primary Completion (Estimated)

June 15, 2029

Study Completion (Estimated)

November 1, 2030

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
More information