LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
EMERALD-3
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)
3 other identifiers
interventional
1,431
28 countries
251
Brief Summary
The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
Longer than P75 for phase_2
251 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
February 6, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
March 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
April 22, 2026
April 1, 2026
4.2 years
February 6, 2026
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
Week 10
Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
Week 52
Secondary Outcomes (6)
Percentage of Participants Who Achieve Clinical Response with mMS
Week 10
Percentage of Participants Who Achieve Clinical Response with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
Week 10 Up to Week 52
Percentage of Participants Who Achieve Symptomatic Response
Baseline Up to Week 8
Percentage of Participants Who Achieve Symptomatic Response Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
Week 10 Up to Week 52
Pharmacokinetics (PK): Plasma Concentrations of LY4268989
Baseline Up to Approximately Week 52
- +1 more secondary outcomes
Study Arms (3)
LY4268989 Study Dose 1
EXPERIMENTALLY4268989 administered orally
LY4268989 Study Dose 2
EXPERIMENTALLY4268989 administered orally
Placebo Study Dose
PLACEBO COMPARATORPlacebo administered orally
Interventions
Eligibility Criteria
You may qualify if:
- Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
- Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1
- Have evidence of UC extending proximal to the rectum
- Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years
- Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded
- Must meet contraception requirements
You may not qualify if:
- Have a current diagnosis of
- Crohn's disease
- Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or
- primary sclerosing cholangitis
- Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
- Have had or will need bowel resection or intestinal or intra-abdominal surgery
- Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic
- Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies
- Have a diagnosis or history of malignant disease within 5 years prior to randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (251)
Valleywise Health Medical Center
Phoenix, Arizona, 85008, United States
One of a Kind Clinical Research Center
Scottsdale, Arizona, 85258, United States
Clinnova Research
Anaheim, California, 92805, United States
GMC Clinical Research
Folsom, California, 95630, United States
Om Research LLC
Temple City, California, 91780, United States
Om Research LLC
Victorville, California, 92395, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Advanced Research Institute - Denver
Denver, Colorado, 80218, United States
Rocky Mountain Gastroenterology Associates - Lakewood
Lakewood, Colorado, 80228, United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518, United States
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, 32114, United States
Clinical Research of Osceola
Kissimmee, Florida, 34741, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Midwest Digestive Health & Nutrition
Des Plaines, Illinois, 60016, United States
Springfield Clinic - First
Springfield, Illinois, 62702, United States
Gastroenterology Health Partners
New Albany, Indiana, 47150, United States
Gastroenterology Health Partners
Louisville, Kentucky, 40218, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan, 49519, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905, United States
KAD Clinical Research
St Louis, Missouri, 63123, United States
Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive
Las Vegas, Nevada, 89128, United States
Virtua Health & Wellness Center - Moorestown
Moorestown, New Jersey, 08057, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Carolina Digestive Diseases and Endoscopy Center
Greenville, North Carolina, 27834, United States
Wilmington Health, PLLC
Wilmington, North Carolina, 28401, United States
Ohio State University
Hilliard, Ohio, 43026, United States
DSI Research - Springboro
Springboro, Ohio, 45066, United States
The Oregon Clinic
Portland, Oregon, 97220, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, 57105, United States
GI Alliance - Fort Worth
Fort Worth, Texas, 76104, United States
GI Alliance - Garland
Garland, Texas, 75044, United States
Integrity Advanced Therapeutics
Houston, Texas, 77090, United States
GI Alliance: Mansfield
Mansfield, Texas, 76063, United States
Southern Star Research Institute
San Antonio, Texas, 78229, United States
GI Alliance - San Marcos
San Marcos, Texas, 78666, United States
Tyler Research Institute
Tyler, Texas, 75701, United States
Eximia Research-VA, LLC
Norfolk, Virginia, 23502, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Principle Research Solutions
Spokane, Washington, 99202, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99208, United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, 98405, United States
Stat Research S.A.
Buenos Aires, C1023AAB, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
GEDYT
Buenos Aires, C1425BGC, Argentina
CER medical Institute
Quilmes, 1878, Argentina
INECO Neurociencias Oroño
Rosario, 2000, Argentina
Hospital Provincial del Centenario
Rosario, 2002, Argentina
Instituto Médico de Alta Complejidad San Isidro Sa
San Isidro, 1642, Argentina
C.I.C.E. 9 de Julio
San Miguel de Tucumán, 4000, Argentina
Loema Instituto de Pesquisa Clinica
Campinas, 13092-133, Brazil
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, 95070-560, Brazil
HNSG
Curitiba, Brazil
Centro de Oncologia Leonardo Da Vinci - ATO Terapias
Fortaleza, 60140-025, Brazil
BRA - Clínica Médica e Terapia Assistida
Itajaí, 88301-220, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90160-092, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador, 41920-900, Brazil
Irmandade da Santa Casa da Misericórdia de Santos
Santos, 11075-900, Brazil
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030, Brazil
Clínica Hepatogastro JK
São Paulo, 04543-011, Brazil
Health Sciences North
Greater Sudbury, P3E 5J1, Canada
QEII Health Sciences Centre - Victoria General Site
Halifax, B3H 2Y9, Canada
London Digestive Disease Institute
London, N6K 1M6, Canada
Binzhou Medical University Hospital
Binzhou, 256603, China
Changzhou Second People's Hospital
Changzhou, 213000, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
Chongqing General Hospital
Chongqing, 401147, China
The First People's Hospital of Foshan
Foshan, 528041, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, 510655, China
Heilongjiang Provincial Hospital
Harbin, 150036, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Huizhou Central People's Hospital
Huizhou, 516001, China
First Affiliated Hospital of Kunming Medical University
Kunming, 650032, China
Liaocheng People's Hospital
Liaocheng, 252000, China
Meihekou Central Hospital
Meihekou, 135000, China
The Affiliated Hospital of Qingdao University
Qingdao, 266003, China
Shanghai Tenth People's Hospital
Shanghai, 200072, China
Shanghai Pudong New District Zhoupu Hospital
Shanghai, 201318, China
Yuebei People's Hospital Guangdong
Shaoguan, 512026, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Taian City Central Hospital
Taian, 271000, China
Wuhan Union Hospital
Wuhan, 430022, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
Zunyi Medical College - No.1 Affiliated Hospital
Zunyi, 563003, China
Clinica de la Costa S.A.S.
Barranquilla, 080020, Colombia
Fundacion Santa Fe de Bogota
Bogotá, 110111, Colombia
Hospital Universitario Mayor Méderi
Bogotá, 111411, Colombia
Hospital Universitario San Ignacio
Bogotá, Colombia
Hospital Pablo Tobon Uribe
Medellín, 050034, Colombia
Poliklinika MEDICO - Rijeka
Rijeka, 51000, Croatia
Klinički Bolnički Centar Split
Split, 21000, Croatia
Klinički bolnički centar Zagreb
Zagreb, 10000, Croatia
Poliklinika Solmed
Zagreb, 10000, Croatia
Hepato-Gastroenterologie HK
Hradec Králové, 500 12, Czechia
Nemocnice Pardubického kraje
Pardubice, 532 03, Czechia
Clinoxus
Prague, 140 00, Czechia
MEDICON
Prague, 140 00, Czechia
ISCARE klinické centrum
Prague, 19000, Czechia
Nemocnice Slany
Slaný, 274 01, Czechia
Nemocnice AGEL Šternberk
Sternberk, 785 01, Czechia
Clinical Trials Service s.r.o.
Uherské Hradiště, 686 01, Czechia
Gastro-nell
Vsetín, 755 01, Czechia
Centres Médico Chirurgicaux - Clinique Ambroise Paré
Neuilly-sur-Seine, 92200, France
CHU Bordeaux Haut-Leveque
Pessac, 33600, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
CHU Rangueil
Toulouse, 31059, France
Evangelismos General Hospital of Athens
Athens, 106 76, Greece
Thoracic General Hospital of Athens "I Sotiria"
Athens, 115 27, Greece
University General Hospital of Heraklion
Heraklion, 711 10, Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, 54642, Greece
Óbudai Egészségügyi Centrum
Budapest, 1036, Hungary
Semmelweis University
Budapest, 1083, Hungary
Clinexpert Gyöngyös
Gyöngyös, 3200, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800, Hungary
KLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi, Belagavi, 590010, India
Motilal Nehru Medical College Hospital
Allahābād, 211002, India
Belagavi Institute of Medical Sciences - Belagavi
Belagavi, 590019, India
Graphic Era Institute of Medical Sciences and Hospital
Dehradun, 248008, India
Mahavir Hospital & Research Centre - Hyderabad
Hyderabad, 500004, India
SR Kalla Memorial Gastro & General Hospital
Jaipur, 302001, India
Lakeshore Hospital
Kochi, 682040, India
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, 226010, India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, 400008, India
Midas Multispeciality Hospital Pvt.Ltd.
Nagpur, 440010, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, 441108, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Yatharth Super Speciality Hospital - Noida Extension
Noida, 201306, India
Gastrohub Hospital
Pune, 411027, India
Lifepoint Multispeciality Hospital
Pune, 411057, India
Pacific Medical College & Hospital
Udaipur, 313001, India
Assuta Ashdod Medical Center
Ashdod, 7747629, Israel
Barzilai Medical Center
Ashkelon, 7830604, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Clalit Health Services - Lev Talpiot Clinic
Jerusalem, 9362410, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Yitzhak Shamir Medical Center
Ẕerifin, 7033001, Israel
IRCCS Policlinico San Donato
Milan, 20097, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Ospedale Di Circolo
Rho, 20017, Italy
Fondazione Policlinico Tor Vergata
Rome, 00133, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152, Italy
Ospedale Isola Tiberina - Gemelli Isola
Rome, 00186, Italy
Humanitas
Rozzano, 20089, Italy
Asahikawa Medical University Hospital
Asahikawa, 078-8510, Japan
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Sai Gastroenterology/Proctology Clinic
Fujiidera, 583-0027, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
National Hospital Organization Hirosaki General Medical Center
Hirosaki, 036-8545, Japan
Sameshima Hospital
Kagoshima, 892-0846, Japan
Tsujinaka Hospital - Kashiwanoha
Kashiwa, 273-0011, Japan
Kyorin University Hospital
Mitaka, 181-8611, Japan
Saiseikai Niigata Hospital
Niigata, 950-1104, Japan
Hyogo Medical University Hospital
Nishinomiya, 663-8501, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Tokitokai Tokito Clinic Coloproctology Center
Saitama, 336-0963, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
The University of Osaka Hospital
Suita, 565-0871, Japan
Tokyo Yamate Medical Center
Tokyo, 169-0073, Japan
Liepjas reionl slimnca
Liepāja, LV-3414, Latvia
Pauls Stradins Clinical Univeristy Hospital
Riga, LV-1002, Latvia
VCA poliklīnika Aura
Riga, LV-1035, Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, LT-50161, Lithuania
Klaipeda University Hospital
Klaipėda, 92288, Lithuania
Viesoji Istaiga Klaipedos Miesto Poliklinika
Klaipėda, 93200, Lithuania
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207, Mexico
Scientia Investigacion Clinica Tj
Ciudad de Tijuana, 22105, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650, Mexico
Private Practice - Dr. Adriana Sánchez
Guadalajara, 44670, Mexico
Proactive CR México SA de CV
Irapuato, 36520, Mexico
Centro de Investigación y Gastroenterología - S.C.
Mexico City, 03330, Mexico
Centro de Investigación Clinica Chapultepec
Mexico City, 04100, Mexico
Keystone Clinical Trials
Mexico City, 06100, Mexico
Hospital Juarez de Mexico
Mexico City, 07760, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
Servicios de Oncología Médica Integral - Monterrey
Monterrey, 66220, Mexico
Centro de Investigacion Clinica Chapultepec
Querétaro, 76088, Mexico
M2M Med
Chorzów, 41-500, Poland
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600, Poland
Polimedica PTG Kielce
Kielce, 25-355, Poland
Oslomed Centrum Medyczne
Krakow, 31-228, Poland
Santa Familia PTG Lodz
Lodz, 90-302, Poland
Twoja Przychodnia PCM
Poznan, 60-324, Poland
ETG Siedlce
Siedlce, 08-110, Poland
Twoja Przychodnia SCM
Szczecin, 71-434, Poland
Sonomed Sp. z o. o.
Szczecin, 71-685, Poland
Clinical Best Solutions
Warsaw, 00-710, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, 04-501, Poland
ETG Zamość
Zamość, 22-400, Poland
2Ca Braga
Braga, 4710-243, Portugal
Hospital da Luz Lisboa
Lisbon, 1500-650, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Unidade Local de Saúde Entre o Douro e Voga
Santa Maria da Feira, 4520-211, Portugal
Pan American Center for Oncology Trials - Ciudadela
San Juan, 00909, Puerto Rico
Adult University Hospital
San Juan, 00935, Puerto Rico
MSB General Hospital
Belgrade, 11000, Serbia
Leskovac General Hospital
Leskovac, 16000, Serbia
Sremska Mitrovica Health Centre
Sremska Mitrovica, 22000, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, 23000, Serbia
Cliniq s.r.o.
Bratislava, 81109, Slovakia
Gastroentero s.r.o.
Bratislava, 821 01, Slovakia
Gastro I., s.r.o.
Prešov, 080 01, Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, 979 01, Slovakia
Accout Center
Šahy, 936 01, Slovakia
Iatros International
Bloemfontein, 9301, South Africa
Mediclinic Panorama
Cape Town, 7500, South Africa
Spoke Research
Cape Town, 7700, South Africa
Lenasia Clinical Trial Centre - Johannesburg
Johannesburg, 1821, South Africa
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Yangsan Hospital
Busan, 50612, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, 34943, South Korea
Chosun University Hospital
Gwangju, 61453, South Korea
Yeungnam Univeristy Medical Center
Gyeongsan-si, 42415, South Korea
Inje University Haeundae Paik Hospital
Haeundae-gu, 48108, South Korea
Kyungpook National University Hospital
Junggu, 41944, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Changhua Christian Hospital
Changhua County, 50006, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Bakent University, Adana Clinic & Research Ctr.
Adana, 01250, Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, 06230, Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100, Turkey (Türkiye)
Ege Universitesi Hastanesi
Bornova, 35100, Turkey (Türkiye)
Mustafa Kemal Universitesi
Hatay, 31030, Turkey (Türkiye)
Bezmialem Vakf Üniversitesi
Istanbul, 34093, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
İzmit, 41380, Turkey (Türkiye)
Mersin University
Mersin, 33110, Turkey (Türkiye)
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58000, Ukraine
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
Kiev, 04050, Ukraine
Edelweiss Medics
Kyiv, 02002, Ukraine
Medical Center Ok!Clinic+
Kyiv, 02091, Ukraine
Medbud Clinic
Kyiv, 03037, Ukraine
Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
Kyiv, 04106, Ukraine
Center of Family Medicine Plus
Kyiv, 04210, Ukraine
Progastro Clinic
Lviv, 79019, Ukraine
Transcarpathian Regional Hospital im.Andriya Novak
Uzhhorod, 88018, Ukraine
Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1"
Vinnytsia, 21029, Ukraine
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Non-responders at week 10 will receive Open Label LY4268989 in maintenance study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2026
First Posted
February 17, 2026
Study Start
March 26, 2026
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
July 1, 2031
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.