A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia (EXCALIBUR-ET2)
August 28, 2026 updated by: Incyte Corporation
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)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
426
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Incyte Corporation Call Center (US)
- Phone Number: 1.855.463.3463
- Email: medinfo@incyte.com
Study Contact Backup
- Name: Incyte Corporation Call Center (ex-US)
- Phone Number: +800 00027423
- Email: eumedinfo@incyte.com
Study Locations
-
-
-
Garran, Australia, 02605
- Not yet recruiting
- The Canberra Hospital
-
Perth, Australia, 06000
- Not yet recruiting
- Royal Perth Hospital
-
-
New South Wales
-
Blacktown, New South Wales, Australia, 02148
- Not yet recruiting
- Blacktown Cancer & Haematology Centre-Blacktown Hospital
-
Gosford, New South Wales, Australia, 02250
- Not yet recruiting
- Gosford Hospital (Gh) - Central Coast Cancer Centre
-
Liverpool, New South Wales, Australia, 02170
- Not yet recruiting
- Liverpool Hospital - South Western Sydney Local Health District
-
-
Queensland
-
Birtinya, Queensland, Australia, 04575
- Not yet recruiting
- Sunshine Coast University Hospital
-
Brisbane, Queensland, Australia, 04029
- Not yet recruiting
- Royal Brisbane and Women's Hospital
-
-
Victoria
-
Melbourne, Victoria, Australia, 03000
- Not yet recruiting
- Peter Maccallum Cancer Centre
-
Melbourne, Victoria, Australia, 03128
- Not yet recruiting
- Box Hill Hospital
-
-
-
-
-
Graz, Austria, 08036
- Not yet recruiting
- Lkh - Medizinische Universitaet Graz
-
Leoben, Austria, 08700
- Not yet recruiting
- Landeskrankenhaus (Lkh) Leoben - Standort Leoben
-
Linz, Austria, 04020
- Not yet recruiting
- Ordensklinikum Linz Gmbh Elisabethinen
-
Vienna, Austria, 01090
- Not yet recruiting
- Medizinische Universitaet Wien, Akh Wien
-
Wels, Austria, 04600
- Not yet recruiting
- Klinikum Wels-Grieskirchen GmbH
-
-
-
-
-
Anderlecht, Belgium, 01070
- Not yet recruiting
- Jules Bordet Lnstitute
-
Brussels, Belgium, 1020
- Not yet recruiting
- Centre Hospitalier Universitaire (Chu) Brugmann (Brugmann University Hospital (Uh)) - Victor Horta
-
Leuven, Belgium, 03000
- Not yet recruiting
- Universitair Ziekenhuis Leuven
-
Liège, Belgium, 04000
- Not yet recruiting
- Centre Hospitalier Universitaire de Liege - Sart Tilman
-
Roeselare, Belgium, 08800
- Not yet recruiting
- Algemeen Ziekenhuis Deltaaretaie
-
Woluwe-Saint-Lambert, Belgium, 01200
- Not yet recruiting
- Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
-
-
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 1Y6
- Not yet recruiting
- St. Paul'S Hospital (Sph), Providence Health Care, University of British Columbia
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Not yet recruiting
- Margaret and Charles Juravinski Cancer Center
-
Kingston, Ontario, Canada, K7L 2V7
- Not yet recruiting
- Queens University, Kingston General Hospital (Kgh), Kingston Health Sciences Centre (Khsc)
-
Toronto, Ontario, Canada, M5G 2M9
- Not yet recruiting
- University Health Network (UHN) - Princess Margaret Cancer Centre
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- Not yet recruiting
- McGill University Health Centre - Glen Site, Centre For Innovative Medicine
-
Montreal, Quebec, Canada, H3T 1E2
- Not yet recruiting
- Sir Mortimer B. Davis - Jewish General Hospital
-
Québec, Quebec, Canada, G6V 3Z1
- Not yet recruiting
- Hotel-Dieu De Levis
-
-
-
-
-
Brno, Czechia, 625 00
- Not yet recruiting
- Fakultní Nemocnice Brno
-
Ostrava-poruba, Czechia, 708 52
- Not yet recruiting
- Fakultni nemocnice Ostrava
-
Prague, Czechia, 12808
- Not yet recruiting
- Vseobecna Fakultni Nemocnice v Praze
-
Prague, Czechia, 100 34
- Not yet recruiting
- Faculty Hospital Kralovske Vinohrady
-
Prague, Czechia, 12820
- Not yet recruiting
- Ustav Hematologie A Krevni Transfuze (Uhkt)
-
-
-
-
-
Amiens, France, 80054
- Not yet recruiting
- CHU d'Amiens-Picardie - Hôpital Sud
-
Bordeaux, France, 33076
- Not yet recruiting
- Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
-
Brest, France, 29200
- Not yet recruiting
- Chu de Brest Hopital de La Cavale Blanche Cic Hematologie
-
Créteil, France, 94000
- Not yet recruiting
- Hospital Henri Mondor
-
Le Kremlin-Bicêtre, France, 94275
- Not yet recruiting
- Hopital Bicetre - Paris Sud (Ap-Hp)
-
Nice, France, 06200
- Not yet recruiting
- Centre Hospitalier Universitaire de Nice,Hopital L Archet
-
Paris, France, 75010
- Not yet recruiting
- Hospital Saint-Louis - Aphp
-
Poitiers, France, 86021
- Not yet recruiting
- Centre Hospitalier Universitaire de Poitiers La Miletrie
-
Toulouse, France, 31059
- Not yet recruiting
- Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole
-
-
-
-
-
Aachen, Germany, 52074
- Not yet recruiting
- Uniklinik Rwth Aachen Medizinische Klinik Iv
-
Berlin, Germany, 10117
- Not yet recruiting
- Charité - Universitaetsmedizin Berlin
-
Dresden, Germany, 01307
- Not yet recruiting
- Bag Onkologische Gemeinschaftspraxis Illmer, Jacobasch, Wolf, Freiberg-Richter Fae Fur Innere Medizi
-
Freiburg im Breisgau, Germany, 79106
- Not yet recruiting
- Universitaetsklinikum Freiburg
-
Halle, Germany, 06120
- Not yet recruiting
- Universitaetsklinikum Halle
-
Hamburg, Germany, 20246
- Not yet recruiting
- Universitaetsklinikum Hamburg-Eppendorf
-
Hanover, Germany, 30625
- Not yet recruiting
- Medizinische Hochschule Hannover, Hannover Medical School
-
Homburg, Germany, 66421
- Not yet recruiting
- Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
-
Jena, Germany, 07747
- Not yet recruiting
- Universitaetsklinikum Jena
-
Lübeck, Germany, 23562
- Not yet recruiting
- Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck
-
Mainz, Germany, 55131
- Not yet recruiting
- University Hospital Johannes Gutenberg - University of Mainz
-
Mannheim, Germany, 68167
- Not yet recruiting
- Medizinische Fakultaet Mannheim Der Universitaet Heidelberg
-
Minden, Germany, 32429
- Not yet recruiting
- Johannes Wesling Klinikum Minden
-
-
-
-
-
Budapest, Hungary, 01088
- Not yet recruiting
- Semmelweis University-Internal Medicine and Haematology
-
Debrecen, Hungary, 04032
- Not yet recruiting
- Debreceni Egyetem Klinikai Kozpont
-
Pécs, Hungary, 07624
- Not yet recruiting
- University of Pecs
-
-
-
-
-
Bari, Italy, 70124
- Not yet recruiting
- Aou Policlinico Consorziale Bari - Uo Ematologia Con Trapianto
-
Bergamo, Italy, 24127
- Not yet recruiting
- Asst Papa Giovanni Xxiii (Azienda Ospedaliera Papa Giovanni Xxiii)
-
Bologna, Italy, 40138
- Not yet recruiting
- Istituto Di Ematologia L. E A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola Mal
-
Catania, Italy, 95123
- Not yet recruiting
- Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco
-
Florence, Italy, 50134
- Not yet recruiting
- Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
-
Genova, Italy, 16132
- Not yet recruiting
- Irccs - Azienda Ospedaliera Universitaria - Ist San Martino
-
Meldola, Italy, 47014
- Not yet recruiting
- Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Ematologia
-
Milan, Italy, 20122
- Not yet recruiting
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano
-
Novara, Italy, 28100
- Not yet recruiting
- Ao Maggiore Della Carita
-
Pavia, Italy, 27100
- Not yet recruiting
- Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo
-
Rome, Italy, 00144
- Not yet recruiting
- Ospedale S. Eugenio
-
Rome, Italy, 00161
- Not yet recruiting
- Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma
-
Rome, Italy, 00168
- Not yet recruiting
- Universita Cattolica Del Sacro Cuore - Policlinico Universitario Agostino Gemelli
-
Torino, Italy, 10128
- Not yet recruiting
- Ao Ordine Mauriziano Di Torino
-
Udine, Italy, 33100
- Not yet recruiting
- Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia
-
Verona, Italy, 37100
- Not yet recruiting
- Universita Degli Studi Di Verona
-
-
-
-
-
Bunkyō City, Japan, 113-8431
- Not yet recruiting
- Juntendo University Hospital
-
Bunkyō City, Japan, 113-8603
- Not yet recruiting
- Nippon Medical School Hospital
-
Chūō, Japan, 409-3898
- Not yet recruiting
- University of Yamanashi Hospital
-
Fukuoka, Japan, 812-8582
- Not yet recruiting
- Kyushu University Hospital
-
Fukushima, Japan, 960-1295
- Not yet recruiting
- Fukushima Medical University Hospital
-
Hirakata, Japan, 5731191
- Not yet recruiting
- Kansai Medical University Hospital
-
Kagoshima, Japan, 890-8520
- Not yet recruiting
- Kagoshima University Hospital
-
Kashiwa-shi, Japan, 277-8577
- Not yet recruiting
- National Cancer Center Hospital East
-
Kobe, Japan, 650-0047
- Not yet recruiting
- Kobe City Medical Center General Hospital
-
Miyazaki, Japan, 889-1692
- Not yet recruiting
- University of Miyazaki Hospital
-
Osaka, Japan, 545-8586
- Not yet recruiting
- Osaka Metropolitan University Hospital
-
Sakai, Japan, 590-0197
- Not yet recruiting
- Kindai University Hospital
-
Shinjuku-ku, Japan, 160-0023
- Not yet recruiting
- Tokyo Medical University Hospital
-
Tsu, Japan, 514-8507
- Not yet recruiting
- Mie University Graduate School of Medicine
-
Tōon, Japan, 791-0295
- Not yet recruiting
- Ehime University Hospital
-
-
-
-
-
Amsterdam, Netherlands, 1105 AZ
- Not yet recruiting
- Amsterdam Universitair Medisch Centrum, Locatie Amsterdam Medisch Centrum
-
Groningen, Netherlands, 9713 GZ
- Not yet recruiting
- University Medical Center Groningen
-
Nijmegen, Netherlands, 6525 GA
- Not yet recruiting
- Radboud University Medical Center
-
Rotterdam, Netherlands, 3015 GD
- Not yet recruiting
- Erasmus University Medical Center
-
Utrecht, Netherlands, 3584 CX
- Not yet recruiting
- Universitair Medisch Centrum Utrecht (Umc Utrecht)
-
-
-
-
-
Bergen, Norway, 05021
- Not yet recruiting
- Haukeland University Hospital
-
Grålum, Norway, 01714
- Not yet recruiting
- Ostfold Hospital
-
-
-
-
-
Gdansk, Poland, 80-952
- Not yet recruiting
- Uniwersyteckie Centrum Kliniczne (UCK)
-
Katowice, Poland, 40-519
- Not yet recruiting
- Pratia Onkologia Katowice
-
Krakow, Poland, 31-501
- Not yet recruiting
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
-
Lodz, Poland, 93-513
- Not yet recruiting
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
Lublin, Poland, 20-081
- Not yet recruiting
- Uniwersytecki Szpital Kliniczny nr 1 w Lublinie
-
Warsaw, Poland, 02-776
- Not yet recruiting
- Instytut Hematologii I Transfuzjologii (Iht) (Institute of Haematology and Transfusion Medicine)
-
Wałbrzych, Poland, 58-309
- Not yet recruiting
- Specjalistyczny Szpital Im. Dr Alfreda Sokolowskiego
-
-
-
-
-
Busan, South Korea, 49241
- Not yet recruiting
- Pusan National University Hospital (PNUH)
-
Seongnam-si, South Korea, 13620
- Not yet recruiting
- Seoul National University Bundang Hospital (SNUBH)
-
Seoul, South Korea, 03080
- Not yet recruiting
- Seoul National University Hospital
-
Seoul, South Korea, 05505
- Not yet recruiting
- Asan Medical Center
-
Seoul, South Korea, 02841
- Not yet recruiting
- Korea University Anam Hospital
-
Seoul, South Korea, 06591
- Not yet recruiting
- The Catholic University of Korea Seoul St. Mary'S Hospital
-
Seoul, South Korea, 03722
- Not yet recruiting
- Severance Hospital Yonsei University Health System
-
-
-
-
-
Alicante, Spain, 03010
- Not yet recruiting
- Hospital General Unviersitario de Alicante
-
Barcelona, Spain, 08035
- Not yet recruiting
- Hospital Universitario Vall d'Hebron
-
Barcelona, Spain, 08036
- Not yet recruiting
- Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
-
Bilbao, Spain, 48013
- Not yet recruiting
- Hospital Universitario de Basurto
-
L'Hospitalet de Llobregat, Spain, 08908
- Not yet recruiting
- Instituto Catalan de Oncologia - Hospital Duran I Reynals
-
Las Palmas de Gran Canaria, Spain, 35010
- Not yet recruiting
- Hospital Universitario de Gran Canaria Doctor Negrín
-
Madrid, Spain, 28034
- Not yet recruiting
- Hospital Universitario Ramón y Cajal
-
Madrid, Spain, 28041
- Not yet recruiting
- Hospital Universitario 12 de Octubre
-
Majadahonda, Spain, 28222
- Not yet recruiting
- Hospital Universitario Puerta de Hierro de Majadahonda
-
Málaga, Spain, 29010
- Not yet recruiting
- Hospital Universitario Virgen de la Victoria
-
Palma, Spain, 07120
- Not yet recruiting
- Hospital Universitari Son Espases
-
Salamanca, Spain, 37007
- Not yet recruiting
- Hospital Clinico Universitario de Salamanca
-
Santiago de Compostela, Spain, 15706
- Not yet recruiting
- Hospital Clinico Universitario de Santiago de Compostela
-
Valencia, Spain, 46017
- Not yet recruiting
- Hospital Universitario Doctor Peset
-
Zaragoza, Spain, 05009
- Not yet recruiting
- Hospital Universitario Miguel Servet ( Hospital Infantil)
-
-
-
-
-
Bern, Switzerland, 03010
- Not yet recruiting
- University Hospital Bern (Inselspital)
-
Sankt Gallen, Switzerland, 09007
- Not yet recruiting
- Hoch Health Ostschweiz, Kantonsspital St. Gallen
-
Tellstrasse, Switzerland, 05001
- Not yet recruiting
- Center of Oncology, Hematology and Transfusionmedicine
-
Zurich, Switzerland, 08091
- Not yet recruiting
- UniversitätsSpital Zürich
-
-
-
-
-
Cambridge, United Kingdom, CB2 0QQ
- Not yet recruiting
- Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
-
Edinburgh, United Kingdom, EH4 2XU
- Not yet recruiting
- Western General Hospital - Lothian Health Board
-
Harrow, United Kingdom, HA1 3UJ
- Not yet recruiting
- Northwick Park Hospital - London North West University Healthcare Nhs Trust
-
Leeds, United Kingdom, LS9 7TF
- Not yet recruiting
- St James's University Hospital - Leeds Teaching Hospitals NHS Trust
-
London, United Kingdom, SE1 9RT
- Not yet recruiting
- Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
-
Newcastle upon Tyne, United Kingdom, NE7 7DN
- Not yet recruiting
- Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
-
Oxford, United Kingdom, OX3 7LJ
- Not yet recruiting
- Cancer and Haematology Centre-the Churchill Hospital-Oxford University Hospitals
-
Penzance, United Kingdom, TR18 2PF
- Not yet recruiting
- Royal Cornwall Hospital - Royal Cornwall Hospitals Nhs Trust
-
-
-
-
Arizona
-
Gilbert, Arizona, United States, 85234
- Not yet recruiting
- Banner MD Anderson Cancer Center
-
Tucson, Arizona, United States, 85724-5024
- Not yet recruiting
- The University of Arizona Cancer Center
-
-
California
-
Duarte, California, United States, 91010
- Not yet recruiting
- City of Hope Medical Center
-
Greenbrae, California, United States, 94904
- Recruiting
- Marin Cancer Care
-
Los Angeles, California, United States, 90095
- Not yet recruiting
- University of California, Los Angeles Medical Center
-
Palo Alto, California, United States, 94304
- Not yet recruiting
- Stanford Cancer Center
-
-
Colorado
-
Lone Tree, Colorado, United States, 80124
- Not yet recruiting
- Rocky Mountain Cancer Centers-Lone Tree
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20007
- Not yet recruiting
- Medstar Georgetown Medical Center, Inc
-
-
Florida
-
Fort Myers, Florida, United States, 33901
- Not yet recruiting
- Florida Cancer Specialists & Research Institute
-
Miami, Florida, United States, 33136
- Not yet recruiting
- University of Miami Sylvester Comprehensive Cancer Center
-
Weston, Florida, United States, 33331
- Not yet recruiting
- Cleveland Clinic
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Not yet recruiting
- Winship Cancer Institute of Emory University
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Not yet recruiting
- University of Chicago
-
Chicago, Illinois, United States, 60611
- Not yet recruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
-
-
Kansas
-
Westwood, Kansas, United States, 66205
- Not yet recruiting
- The University of Kansas Cancer Center
-
-
Maryland
-
Baltimore, Maryland, United States, 21231
- Not yet recruiting
- Johns Hopkins Medicine-the Sidney Kimmel Comprehensive Cancer Center
-
Columbia, Maryland, United States, 21044
- Not yet recruiting
- Maryland Oncology Hematology, P.A.
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Not yet recruiting
- Massachusetts General Hospital
-
Boston, Massachusetts, United States, 02215
- Not yet recruiting
- Beth Israel Deaconess Medical Center (BIDMC)
-
Worcester, Massachusetts, United States, 01655
- Not yet recruiting
- University of Massachusetts Medical School
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109-4000
- Not yet recruiting
- University of Michigan Rogel Cancer Center Adult Bone Marrow Transplant Clinic
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Not yet recruiting
- Missouri Cancer Associates
-
St Louis, Missouri, United States, 63110
- Not yet recruiting
- Washington University School of Medicine
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Not yet recruiting
- John Theurer Cancer Center, Hackensack University Medical Center
-
New Brunswick, New Jersey, United States, 08901
- Not yet recruiting
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
New York, New York, United States, 10029
- Not yet recruiting
- Icahn School of Medicine at Mount Sinai
-
New York, New York, United States, 10065
- Not yet recruiting
- Memorial Sloan Kettering Cancer Center
-
New York, New York, United States, 10065
- Not yet recruiting
- Weill Cornell Medical College - Newyork-Presbyterian Hospita
-
Rochester, New York, United States, 14642
- Not yet recruiting
- Strong Memorial Hospital University of Rochester Medical Center
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Not yet recruiting
- Duke University Medical Center
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Not yet recruiting
- Cleveland Clinic Taussig Cancer Ctr
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Not yet recruiting
- Willamette Valley Cancer Institute and Research Center
-
Portland, Oregon, United States, 97239
- Not yet recruiting
- Oregon Health and Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Not yet recruiting
- Thomas Jefferson University Sidney Kimmel Medical College
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Not yet recruiting
- Vanderbilt University Medical Center
-
Nashville, Tennessee, United States, 37232-5735
- Not yet recruiting
- Vanderbilt University Medical Center
-
-
Texas
-
Houston, Texas, United States, 77030
- Not yet recruiting
- The University of Texas-Md Anderson Cancer Center
-
San Antonio, Texas, United States, 78229
- Not yet recruiting
- UT Health Science Center at San Antonio
-
Tyler, Texas, United States, 75702
- Not yet recruiting
- Texas Oncology-Tyler
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Not yet recruiting
- Huntsman Cancer Institute At University of Utah
-
-
Washington
-
Seattle, Washington, United States, 98109
- Not yet recruiting
- University of Washington - Fred Hutch Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: INCA033989
Administered intravenous (IV) in accordance with the protocol-defined requirements.
|
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.
|
Best Available Therapy (BAT) will be selected by the investigator.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Durable clinicohematologic response (DCR)
Time Frame: Week 24
|
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
|
Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction from baseline in calreticulin exon 9 frameshift mutation(s) (mutCLAR) variant allele frequency (VAF)
Time Frame: Week 24
|
Reduction in mutCALR VAF as defined in the protocol.
|
Week 24
|
|
Durable clinicohematologic response (DCR)
Time Frame: Week 48
|
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
|
Week 48
|
|
Durable partial clinicohematologic response (DPR)
Time Frame: Week 24
|
Improvement of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
|
Week 24
|
|
Durable partial clinicohematologic response (DPR)
Time Frame: Week 48
|
Improvement of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
|
Week 48
|
|
Longest duration of complete hematologic response (CHR)
Time Frame: Up to Week 48
|
Longest time from documented CHR until the loss of CHR as defined in the protocol.
|
Up to Week 48
|
|
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Time Frame: Up to Week 48 and 60 days after last dose
|
Defined as any adverse event occurring after the first dose of study drug until up to 60 days after the last dose of study drug.
|
Up to Week 48 and 60 days after last dose
|
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Time Frame: Up to Week 48 and 60 days after last dose
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
|
Up to Week 48 and 60 days after last dose
|
|
Number of participants with a reduction in mutCALR VAF
Time Frame: Week 24 and Week 48
|
Number of participants with a reduction in mutCALR VAF as defined in the protocol.
|
Week 24 and Week 48
|
|
Molecular response
Time Frame: Week 24 and Week 48
|
Overall reduction in mutCALR VAF as defined in the protocol.
|
Week 24 and Week 48
|
|
Change from baseline in Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) total symptom score (TSS)
Time Frame: Up to Week 48
|
Defined as the proportion of participants who achieve a protocol defined reduction in TSS.
|
Up to Week 48
|
|
Change from baseline in Brief Fatigue Inventory (BFI) fatigue score
Time Frame: Up to Week 48
|
The BFI is a 9 item scored from 0 (no fatigue) -10 (as bad as you can imagine), items are averaged with total score from 0-10, with higher score indicating more fatigue.
|
Up to Week 48
|
|
Patient Global Impression of Change (PGIC) score
Time Frame: Up to Week 48
|
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
|
Up to Week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Incyte Medical Monitor, Incyte Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 8, 2026
Primary Completion (Estimated)
June 15, 2029
Study Completion (Estimated)
November 1, 2030
Study Registration Dates
First Submitted
May 29, 2026
First Submitted That Met QC Criteria
May 29, 2026
First Posted (Actual)
June 3, 2026
Study Record Updates
Last Update Posted (Actual)
August 31, 2026
Last Update Submitted That Met QC Criteria
August 28, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INCA033989-304
- 2026-525398-38-00 (Registry Identifier: EU CT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.