Study Stopped
The study was terminated due to futility.
To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis
2 other identifiers
interventional
252
17 countries
177
Brief Summary
The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2021
Typical duration for phase_3
177 active sites
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
September 11, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedStudy Start
First participant enrolled
May 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2023
CompletedResults Posted
Study results publicly available
October 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2024
CompletedOctober 21, 2025
September 1, 2025
2.2 years
September 11, 2020
July 10, 2024
October 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants)
Participants had an MRI of the upper and lower abdomen and pelvis to determine the spleen volume. A CT scan was substituted for participants who were not candidates for MRI or when MRI was not readily available. Determination of spleen length below the left costal margin was measured by palpation, using a flexible ruler provided by the sponsor.
Baseline; Week 24
Secondary Outcomes (8)
Percentage of Participants Who Had a ≥50% Reduction in Total Symptom Score (TSS) From Baseline to Week 24 as Measured by the Myelofibrosis Symptom Assessment Form v4.0 (MFSAF v4.0) Diary
Baseline; Week 24
Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary
Baseline; Week 24
Time to the First ≥50% Reduction in TSS as Measured by the MFSAF v4.0 Diary
Baseline; up to Week 24
Overall Survival
up to 749 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
up to 960 days
- +3 more secondary outcomes
Study Arms (2)
Group A : parsaclisib + ruxolitinib
EXPERIMENTALParticipants will receive parsaclisib and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.
Group B : placebo + ruxolitinib
PLACEBO COMPARATORParticipants will receive placebo and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.
Interventions
parsaclisib will be administered QD orally
ruxolitinib will be administered BID orally
Eligibility Criteria
You may qualify if:
- Diagnosis of PMF, PPV-MF, or PET-MF.
- DIPSS risk category of intermediate-1, intermediate-2, or high.
- Palpable spleen of ≥ 5 cm below the left costal margin on physical examination at the screening visit.
- Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of ≥ 10 using the Screening Symptom Form.
- Participants with an ECOG performance status score of 0, 1, or 2.
- Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF.
- Life expectancy of at least 24 weeks.
- Willingness to avoid pregnancy or fathering children.
You may not qualify if:
- Prior use of any JAK inhibitor.
- Prior therapy with any drug that inhibits PI3K (examples of drugs targeting this pathway include but are not limited to INCB040093, idelalisib, duvelisib, buparlisib, copanlisib, and umbralisib).
- Use of experimental drug therapy for MF or any other standard drug (eg, danazol, hydroxyurea) used for MF within 3 months of starting study drug and/or lack of recovery from all toxicities from previous therapy to ≤ Grade 1.
- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
- Recent history of inadequate bone marrow reserve.
- Inadequate liver and renal function at screening.
- Active bacterial, fungal, parasitic, or viral infection that requires therapy.
- Active HBV or HCV infection that requires treatment or at risk for HBV reactivation.
- Known HIV infection.
- Uncontrolled, severe, or unstable cardiac disease that in the investigator's opinion may jeopardize the safety of the participant or compliance with the Protocol.
- Active invasive malignancy over the previous 2 years.
- Splenic irradiation within 6 months before receiving the first dose of study drug.
- Concurrent use of any prohibited medications.
- Active alcohol or drug addiction that would interfere with the ability to comply with the study requirements.
- Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives(whichever is longer) before the first dose of study drug or anticipated during the study.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (177)
Alaska Oncology and Hematology
Anchorage, Alaska, 99508, United States
Mayo Clinic Rochester
Phoenix, Arizona, 85054, United States
Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, 94704, United States
CCARE
Fresno, California, 93720, United States
California Research Institute (Cri)
Los Angeles, California, 90027-6005, United States
UCLA School of Medicine
Los Angeles, California, 90095-3075, United States
Scripps Clinic
San Diego, California, 92103, United States
Coastal Integrated Cancer Care-Cicc
San Luis Obispo, California, 93401, United States
Stamford Hospital-Medical Oncology Hematology
Stamford, Connecticut, 06904, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Kansas Hospital Authority
Westwood, Kansas, 66205, United States
University of Kentucky-Markey Cancer Center
Lexington, Kentucky, 40536, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Midamerica Cancer Care
Kansas City, Missouri, 64114, United States
New Jersey Hematology Oncology Associates Llc
Brick, New Jersey, 08724, United States
Morristown Medical Center-Atlantic Health System
Morristown, New Jersey, 07960, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Westchester Medical Center Advanced Oncology and Infusion Center
Hawthorne, New York, 10532, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Ohio State University
Columbus, Ohio, 43210, United States
Kaiser Permanente-Northwest
Portland, Oregon, 97227, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57103, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, 75246-2092, United States
Kelsey Seybold Clinic
Houston, Texas, 77025, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Renovatio Clinical
Spring, Texas, 77380, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Ordensklinikum Linz Gmbh Elisabethinen
Linz, 04020, Austria
Universitaetsklinikum St. Poelten
Saint P�LTEN, 03100, Austria
Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse
Vienna, 01140, Austria
Hanusch-Krankenhaus Wiener Gebietskrankenkasse
Vienna, 01140, Austria
A.Z. St.-Jan A.V.
Bruges, 08000, Belgium
Cliniques Universitaires Ucl Saint-Luc
Brussels, 01000, Belgium
Grand Hospital de Charleroi
Charleroi, 06000, Belgium
Jessa Ziekenhuis
Hasselt, 03500, Belgium
AZ DELTA
Roeselare, 08800, Belgium
Affiliated Hospital of Hebei University
Baoding, 71000, China
Peking University People'S Hospital (Pkuph) - Institute of Hematology
Beijing, 100044, China
Peking University Third Hospital
Beijing, 100091, China
The First Hospital of Jilin University
Changchun, 130021, China
Xiangya Hospital Central South University
Changsha, 410008, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Guangdong Provincial of People Hospital
Guangzhou, 510080, China
Nanfang Hospital
Guangzhou, 510515, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, 310003, China
Harbin Institute of Hematology and Oncology
Harbin, 150010, China
Anhui Provincial Hospital
Hefei, 230001, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, 10050, China
Jinan Central Hospital
Jinan, 250013, China
The First Hospital of Lanzhou University
Lanzhou, 730000, China
Lanzhou University Second Hospital
Lanzhou, 730030, China
Jiangxi Provincial of People Hospital
Nanchang, 330000, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Jiangsu Province Hospital
Nanjing, 210029, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Shenzhen University Hospital
Shenzhen, 518055, China
The Second Hospital of Hebei Medical University
Shijiazhuang, 50000, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022, China
Yantai Yuhuangding Hospital
Yantai, 264000, China
Henan Provincial Peoples Hospital
Zhengzhou, 450003, China
Aalborg University Hospital
Aalborg, 09000, Denmark
Odense University Hospital
Odense, 05000, Denmark
Helsinki University Central Hospital
Helsinki, FI-00029, Finland
Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
La Tronche, 38700, France
Centre Hospitalier de Versailles - Hopital Andre Mignot
LE Chesnay-rocquencourt, 78157, France
Chu Limoges - Hopital Dupuytren
Limoges, 87042, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, 44093, France
Chu Nimes
Nîmes, 30900, France
Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)
Paris, 75010, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Hospital de La Miletrie
Poitiers, 86021, France
Chu de Rennes - Hospital Pontchaillou
Rennes, 35033, France
Centre Hospitalier de Roubaix
Roubaix, 59100, France
Universitatsklinikum Halle (Saale)
Halle, 06120, Germany
Klinikum Kassel Gmbh
Kassel, 34125, Germany
Universitatsklinikum Magdeburg A.O.R.
Magdeburg, 39120, Germany
Universitaetsmedizin Rostock
Rostock, 18057, Germany
Shamir Medical Center Formerly Assaf Harofeh Medical Center
BEER Yaaqov, 70300, Israel
Rambam Health Care Campus
Haifa, 31999, Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem, 91120, Israel
Davidoff Cancer Center Rabin Medical Center
Petah Tikva, 49100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Assuta Ramat Hahayal
Tel Aviv, 69710, Israel
Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or
Bologna, 40138, Italy
Azienda Policlinico Vittorio Emanuele
Catania, 95123, Italy
Universita Degli Studi Di Genova - Facolta Di Medicina E Chirurgia
Genova, 16132, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
Meldola, 47014, Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan, 20132, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122, Italy
Universita Di Napoli Federico Ii
Napoli, 80131, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146, Italy
Aormn Hospital Hematology and Bmt Center
Pesaro, 61122, Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, 89133, Italy
Universita Di Roma Tor Vergata
Roma, 00133, Italy
Universita Di Roma
Roma, 00161, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Roma, 00168, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, 00168, Italy
Aou San Giovanni Di Dio E Ruggi D'Aragona
Salerno, 84131, Italy
Azienda Ospedaliera San Giuseppe Moscati
Taranto, 74123, Italy
Azienda Sanitaria Universitaria Friuli Centrale Asu Fc
Udine, 33100, Italy
A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi
Varese, 21100, Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, 37134, Italy
Chiba Cancer Center
Chiba, 260-8677, Japan
University of Yamanashi Hospital
Chūō, 409-3898, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-shi, 670-8540, Japan
Kansai Medical University Hospital
Hirakata, 573-1191, Japan
Tokai University Hospital
Isehara, 2591193, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Hospital of the University of Occupation and Environmental Health
Kitakyushu-shi, 807-8556, Japan
Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
Kumamoto Shinto General Hospital
Kumamoto, 862-8655, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Japanese Red Cross Nagoya Daini Hospital
Nagoya, 453-8511, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8585, Japan
Ogaki Municipal Hospital
Ōgaki, 5038502, Japan
Dokkyo Medical University Saitama Medical Center
Saitama, 343-8555, Japan
Hokuyukai Sapporo Hokuyu Hospital
Sapporo, 003-0006, Japan
Tohoku University Hospital
Sendai, 980-8574, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Nippon Medical School Hospital
Tokyo, 113-8603, Japan
Mie University Hospital
Tsu, 514-0001, Japan
Yokohama Municipal Citizens Hospital
Yokohama, 221-0855, Japan
Haukeland University Hospital
Bergen, 05021, Norway
Akershus University Hospital
L�RENSKOG, 01478, Norway
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Samodzielny Publiczny Szpital Kliniczny Im. Andrzeja Mielckiego
Katowice, 40-027, Poland
Pratia Hematologia Katowice
Katowice, 41-519, Poland
Sp Zoz Szpital Uniwersytecki
Krakow, 31-501, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, 20-081, Poland
Institute of Hematology and Transfusion Medicine
Warsaw, 02-776, Poland
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 03651, South Korea
THE CATHOLIC UNIVERSITY OF KOREA SEOUL ST. MARY�S HOSPITAL
Seoul, 06591, South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Hospital General Unviersitario de Alicante
Alicante, 3010, Spain
Ico Hospital Germans Trias I Pujol
Badalona, 08916, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Hospital General Universitario Vall D Hebron
Barcelona, 08035, Spain
Ico-Hospital Duran I Reynals
Barcelona, 08908, Spain
Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
Barcelona, 08908, Spain
Ico Hospital Germans Trias I Pujol
Barcelona, 08916, Spain
Hospital de Basurto
Bilbao, 48013, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, 30120, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, 35010, Spain
Fundacian Jimnez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitari I Politecnic La Fe
Valencia, 46000, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Baskent University Adana Hospital
Adana, 01250, Turkey (Türkiye)
Gazi University Hospital Gazi University Faculty of Medicine
Ankara, 06500, Turkey (Türkiye)
Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Baskent University Istanbul Hospital
Istanbul, 34662, Turkey (Türkiye)
Ege University Hospital
Izmir, 35040, Turkey (Türkiye)
Dokuz Eylul University
Izmir, 35340, Turkey (Türkiye)
Ondokuz Mayis University Medicine Faculty
Samsun, 55200, Turkey (Türkiye)
United Lincolnshire Hospitals
Boston, PE21 9QS, United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN, United Kingdom
Barts Health Nhs Trust - St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
University College London Hospitals Nhs Foundation Trust
London, NW1 2BU, United Kingdom
Sheffield Teaching Hospitals Nhs Foundation Trust - Weston Park Hospital
Sheffield, S5 7AT, United Kingdom
University Hospital of North Midlands Nhs Trust
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to participants rolling over to another study (NCT02955940), no participants randomized to receive placebo plus ruxolitinib switched to treatment with parsaclisib plus ruxolitinib.
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Albert Assad, M.D
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Triple blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2020
First Posted
September 16, 2020
Study Start
May 24, 2021
Primary Completion
August 3, 2023
Study Completion
November 25, 2024
Last Updated
October 21, 2025
Results First Posted
October 4, 2024
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- 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.
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