A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
LUCERNA
A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive
4 other identifiers
interventional
500
21 countries
224
Brief Summary
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy. Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections. The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.
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 2025
Typical duration for phase_3
224 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
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
March 30, 2025
CompletedStudy Start
First participant enrolled
May 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
April 29, 2026
April 1, 2026
3.4 years
March 27, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Up to 72 months
Secondary Outcomes (11)
Progression Free Survival (PFS)
Up to 72 Months
Objective Response Rate (ORR)
Up to 57 Months
Duration of Response (DOR)
Up to 72 Months
Number of participants with adverse Events (AEs)
Up to 57 Months
Number of participants with electrocardiograms (ECG) abnormalities and/or AEs
Up to 57 Months
- +6 more secondary outcomes
Study Arms (2)
Arm A: zolbetuximab in combination with pembrolizumab and chemotherapy
EXPERIMENTALParticipants will receive zolbetuximab as an intravenous (via a vein) infusion at 800 mg/m2 loading dose at C1D1 followed by subsequent doses of 400 mg/m2 every 2 weeks; or 800 mg/m2 loading dose at C1D1 followed by subsequent doses of 600 mg/m2 every 3 weeks, followed by an intravenous infusion of pembrolizumab at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks. Participants will then receive chemotherapy over 4 or more cycles of either up to 8 CAPOX treatments (oxaliplatin: 130 mg/m2 once every 3 weeks, capecitabine: 1000 mg/m2 twice daily on days 1 through 14 and days 22 through 35 of each cycle), or, up to 12 mFOLFOX6 treatments (oxaliplatin: 85 mg/m2, Folinic acid (leucovorin/local equivalent): 400 mg/m2, 5-FU bolus: 400 mg/m2, 5-FU infusion: 2400 mg/m2) once every 2 weeks (or components of mFOLFOX6 if some components are discontinued due to toxicity). The choice of chemotherapy for each participant is based on investigator's judgment. Each cycle is approximately 42 days.
Arm B: Placebo in combination with pembrolizumab and chemotherapy
ACTIVE COMPARATORParticipants will receive matching placebo as an intravenous (via a vein) infusion followed by an intravenous infusion of pembrolizumab at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks. Participants will then receive chemotherapy over 4 or more cycles of either up to 8 CAPOX treatments (oxaliplatin: 130 mg/m2 once every 3 weeks, capecitabine: 1000 mg/m2 twice daily on days 1 through 14 and days 22 through 35 of each cycle), or, up to 12 mFOLFOX6 treatments (oxaliplatin: 85 mg/m2, Folinic acid (leucovorin/local equivalent): 400 mg/m2, 5-FU bolus: 400 mg/m2, 5-FU infusion: 2400 mg/m2) once every 2 weeks (or components of mFOLFOX6 if some components are discontinued due to toxicity). The choice of chemotherapy for each participant is based on investigator's judgment. Each cycle is approximately 42 days.
Interventions
Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion of Folinic acid (leucovorin or local equivalent) once every 2 weeks.
Participants will receive an IV infusion of zolbetuximab on Cycle 1 Day 1 (C1D1) followed by subsequent IV infusion every 2 weeks or every 3 weeks.
Participants will receive an IV infusion of pembrolizumab every 3 weeks or every 6 weeks.
Participants receiving CAPOX regimen of chemotherapy will receive capecitabine Tablet twice daily orally on days 1 through 14 and days 22 through 35 of each cycle.
Participants receiving CAPOX or mFOLFOX6 regimen of chemotherapy will receive an IV infusion of oxaliplatin once every 2 or 3 weeks.
Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion, or IV bolus of 5-FU once every 2 weeks.
Participants will receive an IV infusion of placebo (0.9% of sodium chloride) on C1D1 followed by subsequent IV infusion every 2 weeks or every 3 weeks.
Eligibility Criteria
You may qualify if:
- Participant has histologically confirmed gastric or Gastroesophageal Junction (GEJ) adenocarcinoma.
- Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization.
- Participant has radiologically evaluable disease (measurable and/or nonmeasurable) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1, ≤ 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
- Participant has Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0 to 1.
- Participant has predicted life expectancy ≥ 12 weeks.
- Participant must be a candidate to receive mFOLFOX6 or CAPOX and pembrolizumab.
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of child bearing potential (WOCBP)
- WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (at least 9 months after the final oxaliplatin administration and 6 months after final study intervention administration).
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 6 months after final investigational study intervention administration.
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final investigational study intervention administration.
- Male participant must not donate sperm during the treatment period and for 6 months after the final investigational study intervention administration
- Participant has a Human Epidermal Growth Factor Receptor 2 (HER2) -negative tumor.
- +5 more criteria
You may not qualify if:
- Participant has prior severe allergic reaction or intolerance to zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX.
- Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.
- Participant has significant gastric bleeding and/or untreated gastric ulcers that would preclude the participant from participation.
- Participant has unresolved pneumonitis or history of non-infectious pneumonitis such as immune-related pneumonitis, radiation induced pneumonitis.
- Participant has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
- Participant has a known history of a positive test for Human Immunodeficiency Virus (HIV) infection or known active Hepatitis B Surface Antigen (positive HBsAg) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.
- For participants who are negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, a hepatitis B DNA test will be performed and if positive the participant will be excluded.
- Participants with positive Hepatitis C virus (HCV) serology, but negative HCV RNA test results are eligible.
- Participants treated for HCV with undetectable viral load results are eligible.
- Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.
- Participant has active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.
- Participant has a clinically significant disease or comorbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.
- Participant has another malignancy for which treatment is required.
- Participant has known Dihydropyrimidine Dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements).
- Participant has known peripheral neuropathy \> grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the participant ineligible).
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (224)
UAB Medicine - UAB Hospital
Birmingham, Alabama, 35294, United States
TOI Clinical Research
Cerritos, California, 90703, United States
The Angeles Clinic and Research Institute, West Los Angeles Office
Los Angeles, California, 90025, United States
Hartford HealthCare - Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Piedmont Physician Medical Oncology Atlanta
Atlanta, Georgia, 30318, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Franciscan Health Oncology and Hematology Specialists
Indianapolis, Indiana, 46237, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, 41017, United States
University of Maryland Medical System - University of Maryland Medical Center
Baltimore, Maryland, 21021, United States
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Henry Ford Cancer Institute-Henry Ford Hospital
Detroit, Michigan, 48201, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55426, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center - Duke Cancer Centre
Durham, North Carolina, 27710, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Oncology-Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246, United States
The Center For Cancer And Blood Disorders (Texas Cancer Care)
Fort Worth, Texas, 76104, United States
Houston Methodist Cancer Center
Houston, Texas, 77030, United States
Utah Cancer Specialists Cancer Center - Medical Oncology
Salt Lake City, Utah, 84106, United States
AU61002
Kogarah, New South Wales, Australia
AU61004
Brisbane, Queensland, Australia
AU61003
Clayton, Victoria, Australia
AU61001
Fitzroy, Australia
BE32002
Bonheiden, Belgium
BE32001
Brussels, Belgium
BE32006
Edegem, Belgium
BE32003
Ghent, Belgium
Site BE32005
Leuven, Belgium
BE32004
Liège, Belgium
Site BR55014
Belo Horizonte, Brazil
Site BR55008
Jaú, Brazil
Site BR55004
Lages, Brazil
Site BR55003
Porto Alegre, Brazil
Site BR55006
São Caetano do Sul, Brazil
Site BR55001
São José do Rio Preto, Brazil
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031, China
Fujian Provincial Hospital - Department of Medical Oncology
Fuzhou, Fujian, China
Sun Yat-sen University - Cancer Center
Guangzhou, Guangdong, 510060, China
Sun Yat-sen University - Cancer Center
Guangzhou, Guangdong, 510555, China
Harbin Medical University Cancer Hospital - Oncology
Harbin, Heilongjiang, China
Henan Cancer Hospital - Oncology
Zhenngzhou, Henan, China
Hubei Cancer Hospital - Oncology
Wuhan, Hubei, 430079, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
Renji Hospital Shanghai Jiaotong Univ School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610200, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Affiliated Hospital of Hebei University
Baoding, 71000, China
Peking Union Medical College Hospital - Dongdan Campus
Beijing, China
CZ42006
Brno, Czechia
CZ42003
Prague, Czechia
CZ42004
Prague, Czechia
FR33016
Bordeaux, France
FR-33008
Brest, France
FR33012
Caen, France
FR33009
Carassonne, France
FR33005
Dijon, France
FR33002
Lille, France
FR33007
Lille, France
FR33014
Lyon, France
FR33017
Lyon, France
FR33020
Montpellier, France
FR33018
Nice, France
FR33003
Paris, France
FR33010
Paris, France
FR33013
Paris, France
FR33015
Plérin, France
FR33004
Poitiers, France
FR33006
Rouen, France
FR33019
Saint Herbian Cedex, France
FR33011
Strasbourg, France
DE49013
Berlin, Germany
Site DE49010
Essen, Germany
DE49007
Hanover, Germany
Site DE49004
Leipzig, Germany
DE49001
Mainz, Germany
DE49002
Saarbrücken, Germany
DE49011
Schweinfurt, Germany
DE49016
Wolfsburg, Germany
IT39019
Bergamo, Italy
IT39017
Bologna, Italy
IT39009
Brescia, Italy
IT39014
Candiolo, Italy
IT39006
Cermona, Italy
IT39011
Florence, Italy
IT39007
Meldola, Italy
IT-39020
Milan, Italy
IT39012
Milan, Italy
IT39018
Milan, Italy
IT39021
Naples, Italy
IT-39015
Pisa, Italy
IT39004
Reggio Emilia, Italy
IT39016
Roma, Italy
IT39001
Rome, Italy
IT39003
Torrette Di Ancona, Italy
IT39022
Udine, Italy
IT39002
Verona, Italy
Chiba Cancer Center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kyushu University Hospital (Hematology, Oncology & Cardiovascular medicine)
Fukuoka, Fukuoka, Japan
Kyushu University Hospital(Gastrointestinal Surgery)
Fukuoka, Fukuoka, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kagawa University Hospital
Kida-gun, Kagawa-ken, Japan
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
Kanagawa Cancer Ctr Hospital
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Osaka General Medical Center
Osaka, Osaka, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan
Saitama Cancer Center
Kitaadachi-gun Ina-machi, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
LT37001
Kaunas, Lithuania
LT37002
Vilnius, Lithuania
Site MX52003
Mexico City, Mexico
Site MX52001
Oaxaca City, Mexico
NL-31002
Leeuwarden, Netherlands
NL31001
Nijmegen, Netherlands
PL48005
Lubin, Lubusz Voivodeship, Poland
PL48004
Warsaw, Masovian Voivodeship, Poland
PL48001
Brzozów, Woj Podkarpackie, Poland
PL48008
Olsztyn, Poland
PL48002
Przemyśl, Poland
PL48009
Swidnica, Poland
PL48007
Warsaw, Poland
PT35106
Almada, Portugal
PT35103
Braga, Portugal
PT35104
Guimarães, Portugal
Site PT35102
Lisbon, Portugal
Site PT35107
Lisbon, Portugal
PT35105
Porto, Portugal
PT35108
Porto, Portugal
PT35109
Porto, Portugal
RO40008
Bucharest, Romania
RO40001
Cluj-Napoca, Romania
RO40005
Cluj-Napoca, Romania
RO40006
Cluj-Napoca, Romania
RO40003
Craiova, Romania
RO40002
Floreşti, Romania
RO40007
Iași, Romania
RO40004
Timișoara, Romania
KR82011
Goyang-si, Gyeonggi-do, South Korea
KR82007
Seongnam-si, Gyeonggi-do, South Korea
KR82013
Suwon, Gyeonggi-do, South Korea
KR82015
Suwon, Gyeonggi-do, South Korea
KR82014
Hwasungun, Joellanamdo, South Korea
KR82009
Cheongju-si, North Chungcheong, South Korea
KR82003
Seocho-gu, Seoul, South Korea
KR82004
Daegu, South Korea
KR82005
Incheon, South Korea
KR82001
Seoul, South Korea
KR82002
Seoul, South Korea
KR82006
Seoul, South Korea
KR82008
Seoul, South Korea
KR82010
Seoul, South Korea
KR82012
Seoul, South Korea
ES34022
Elche, Alicante, Spain
ES34023
San Cugat Del Valles Barcelona, Cataluyna, Spain
ES34019
Madrid, Madrid, Spain
ES34027
Madrid, Madrid, Spain
ES34002
Navarra, Pamplona, Spain
ES34005
A Coruña, Spain
ES34006
Barcelona, Spain
ES34009
Barcelona, Spain
ES34010
Barcelona, Spain
ES34011
Barcelona, Spain
ES34024
Barcelona, Spain
ES34026
Barcelona, Spain
ES34021
El Palmar, Spain
ES34014
Lleida, Spain
ES34003
Madrid, Spain
ES34008
Madrid, Spain
ES34016
Madrid, Spain
ES34017
Madrid, Spain
Site ES34031
Madrid, Spain
ES34030
Murcia, Spain
ES34013
Pozuelo de Alarcón, Spain
ES34029
Santiago de Compostela, Spain
ES34012
Seville, Spain
ES34025
Seville, Spain
ES34004
Valencia, Spain
ES34007
Valencia, Spain
ES34015
Zaragoza, Spain
Site ES34018
Zaragoza, Spain
TW-88603
Dawan, Taiwan, Taiwan
TW88604
Kaohsiung City, Taiwan
TW88601
Taichung, Taiwan
TW88606
Tainan, Taiwan
TW88605
Taipei, Taiwan
Site TR90006
Ankara, Turkey (Türkiye)
TR90004
Ankara, Turkey (Türkiye)
Site TR90013
Konya, Turkey (Türkiye)
Site TR90015
Van, Turkey (Türkiye)
GB44010
Cottingham, East Riding Of Yorkshire, United Kingdom
UK44001
Bristol, United Kingdom
Site GB44003
Cardiff, United Kingdom
GB44002
Coventry, United Kingdom
UK44006
Dundee, United Kingdom
GB44004
Glasgow, United Kingdom
GB-44005
London, United Kingdom
UK44011
London, United Kingdom
UK44014
London, United Kingdom
UK44015
London, United Kingdom
UK44016
London, United Kingdom
UK44009
Manchester, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Astellas Pharma Global Development, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 27, 2025
First Posted
March 30, 2025
Study Start
May 22, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.