A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

NCT06589986 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: GA453292024-513014-35-00
• Study Type: interventional
• Target: 400
• Locations: 30 countries
• Sites: 224

Brief Summary

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Conditions

Moderately to Severely Active Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Clinical Remission at Week 12

  Percentage of participants achieving Modified Mayo Score (mMS) \<=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.

  At Week 12

• Percentage of Participants with Clinical Remission at Week 52

  Percentage of participants achieving mMS \<= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.

  At Week 52

Secondary Outcomes (27)

• Change in Partial Modified Mayo Score (pmMS)

  Baseline to Week 2

• Percentage of Participants with Endoscopic Improvement

  At Week 12

• Percentage of Participants with Endoscopic Remission

  At Week 12

• Percentage of Participants with Clinical Response

  At Week 12

• Percentage of Participants with Histologic Improvement

  At Week 12

Study Arms (2)

Afimkibart

EXPERIMENTAL

Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.

Drug: Afimkibart

Placebo

PLACEBO COMPARATOR

Participants will receive placebo IV followed by placebo SC.

Drug: Placebo

Interventions

Afimkibart DRUG

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Also known as: PF-06480605, RVT-3101, RG6631, RO7790121

Afimkibart

Placebo DRUG

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of UC
• Moderately to severely active UC assessed by mMS
• Bodyweight \>= 40 kilogram (kg)
• Up to date with colorectal cancer (CRC) screening performed according to local standards
• Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
• Males and females of childbearing potential must meet protocol criteria for contraception requirements

You may not qualify if:

• Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
• Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
• Presence of an ostomy or ileoanal pouch
• Current diagnosis or suspicion of primary sclerosing cholangitis
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study
• Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
• History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
• Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
• Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
• Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Chugai Pharmaceutical: collaborator

Study Sites (229)

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan

Dothan, Alabama, 36305, United States

Location

Arizona Digestive Health, P.C (ADH)

Sun City, Arizona, 85351, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Stanford Medicine Outpatient Center

Redwood City, California, 94063, United States

Location

Acclaim Clinical Research, Inc.

San Diego, California, 92120, United States

Location

UCSF/Medical Center at Mount Zion

San Francisco, California, 94115, United States

Location

Amicis Research Center

Santa Clarita, California, 91355, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

Peak Gastroenterology Surgery Center

Lone Tree, Colorado, 80124, United States

Location

Access Research Institute

Brooksville, Florida, 34613, United States

Location

Gastro Florida

Clearwater, Florida, 33756, United States

Location

HealthMed Clinical Center Inc.

Coral Gables, Florida, 33134, United States

Location

J&A Clinical Research

Doral, Florida, 33126, United States

Location

Clinical Research of Osceola, LLC

Kissimmee, Florida, 34741, United States

Location

Auzmer Research

Lakeland, Florida, 33813, United States

Location

Florida Research Institute - Lakewood

Lakewood Rch, Florida, 34211, United States

Location

Homestead Associates in Research, Inc.

Miami, Florida, 33033, United States

Location

Allied Biomedical Research Institute, Inc

Miami, Florida, 33155, United States

Location

Miami Beach Clinical Research Center

Miami Beach, Florida, 33141, United States

Location

Eminat Research Group

Miramar, Florida, 33027, United States

Location

Orlando Regional Healthcare

Orlando, Florida, 32806, United States

Location

Nodal Medical Center, LLC

Tampa, Florida, 33607, United States

Location

Theia Clinical Research Centers, LLC

Tampa, Florida, 33613, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Florida Medical Clinic

Zephyrhills, Florida, 33542, United States

Location

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201, United States

Location

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Next Innovative Clinical Research

Chicago, Illinois, 60616, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Gastroenterology Health Partners, PLLC

New Albany, Indiana, 47150, United States

Location

Tri-State Gastroenterology Associates

Crestview Hills, Kentucky, 41017-3409, United States

Location

Robley Rex VA Medical Center

Louisville, Kentucky, 40206, United States

Location

Gastroenterology Health Partners, PLLC

Louisville, Kentucky, 40218, United States

Location

Louisiana Research Center - GastroIntestinal Associates

Shreveport, Louisiana, 71105, United States

Location

Brigham & Womens Hosp

Boston, Massachusetts, 02115, United States

Location

Boston University

Boston, Massachusetts, 02118, United States

Location

Michigan Center of Medical Research

Farmington Hills, Michigan, 48334, United States

Location

Allied Gastrointestinal Associates, PA

Flowood, Mississippi, 39232, United States

Location

BVL Clinical Research

Liberty, Missouri, 64068, United States

Location

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, 89030, United States

Location

Intercity Gastroenterology

Fresh Meadows, New York, 11366, United States

Location

Northwell Health Physician Partners Gastroenterology at Great Neck

Great Neck, New York, 11021, United States

Location

Pioneer Clinical Research NY

New York, New York, 10016, United States

Location

Mainstreet - Richmond Hill Clinic

Richmond Hill, New York, 11418, United States

Location

Digestive Health Partners, PA

Asheville, North Carolina, 28801, United States

Location

Peters Medical Research (PMR), LLC

High Point, North Carolina, 27260, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Digestive Disease Consultants

Brunswick, Ohio, 44212, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio Gastroenterology Group

Columbus, Ohio, 43202, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Gastro Intestinal Research Institute of Northern Ohio

Westlake, Ohio, 44145, United States

Location

University Gastroenterology

Providence, Rhode Island, 02904, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Gastro One

Cordova, Tennessee, 38018, United States

Location

Gastrointestinal Associates of Northeast Tennessee

Johnson City, Tennessee, 37604, United States

Location

Quality Medical Research

Nashville, Tennessee, 37211, United States

Location

Texas Digestive Disease Consultants - Cedar Park

Cedar Park, Texas, 78613, United States

Location

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Proactive El Paso,LLC

El Paso, Texas, 79902, United States

Location

GI Alliance

Garland, Texas, 75044, United States

Location

Baylor College of Medicine.

Houston, Texas, 77030, United States

Location

TDDC dba GI Alliance Research

Mansfield, Texas, 76063, United States

Location

SMS Clinical Research, LLC

Mesquite, Texas, 75149, United States

Location

Digestive System Healthcare - Biopharma Informatic, LLC

Pasadena, Texas, 77505-3950, United States

Location

Carta - Clinical Associates In Research Therapeutics Of America;LLC

San Antonio, Texas, 78212, United States

Location

Southern Star Research Institute, LLC.

San Antonio, Texas, 78229, United States

Location

GI Alliance - Southlake

Southlake, Texas, 76092, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

University of Texas Health Center at Tyler

Tyler, Texas, 75708, United States

Location

Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Gastroenterology Consultants of SWVA

Roanoke, Virginia, 24018, United States

Location

The Vancouver Clinic

Vancouver, Washington, 98664, United States

Location

Marshall Health

Huntington, West Virginia, 25701, United States

Location

Univ of Wisconsin Hosp & Clin

Madison, Wisconsin, 53792, United States

Location

CIPREC Centro de Investigacion y Prevencion Cardiovascular

Ciudad Autonoma Buenos Aires, C1061AAS, Argentina

Location

Expertia S.A- Mautalen Salud e Investigación

Ciudad Autonoma Buenos Aires, C1128AAE, Argentina

Location

The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Mater Misericordiae Limited

South Brisbane, Queensland, 4101, Australia

Location

Lyell McEwin Hospital

Adelaide, South Australia, 5112, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Barmherzige Brüder Wien

Vienna, 1020, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

CHC MontLégia

Liège, 4000, Belgium

Location

CHU de Liège (Sart Tilman)

Liège, 4000, Belgium

Location

Centro Digestivo de Curitiba

Curitiba, Paraná, 80430-160, Brazil

Location

Hospital de Clinicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo, 01228-000, Brazil

Location

BR Trials - Pesquisa Clínica

São Paulo, São Paulo, 03325-050, Brazil

Location

MHAT St. Ivan Rilski

Gorna Oryahovitsa, 5100, Bulgaria

Location

South Edmonton Gastroenterology

Edmonton, Alberta, T6K 4B2, Canada

Location

Hospital Guillermo Grant Benavente

Concepción, 4030000, Chile

Location

Clinica Universidad de Los Andes

Santiago, Chile

Location

Medwal

Santiago, Chile

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Binzhou Medical university hospital

Binzhou, China

Location

the First Hospital of Jilin University

Changchun, 130021, China

Location

Sichuan Provincial People's Hospital

Chengdu, 610072, China

Location

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, 350005, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510080, China

Location

The sixth affiliated hospital of Sun Yat-Sen University

Guangzhou, 510655, China

Location

Anhui Provincial Hospital

Hefei, 230001, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022, China

Location

Huizhou First Hospital

Huizhou, China

Location

Jinhua municipal central hospital

Jinhua, China

Location

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, 330006, China

Location

Nanjing 1st Hospital

Nanjing, 210006, China

Location

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

Location

Peking University Shenzhen Hospital

Shenzhen, 518036, China

Location

Hebei Medical University - The Second Hospital

Shijiazhuang, 050004, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430022, China

Location

Ren Min Hospital Affiliated Wu Han University

Wuhan, 430060, China

Location

Wuxi People's Hospital

Wuxi, 214023, China

Location

The Second Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, 710004, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Zhuzhou Central Hospital

Zhuzhou, China

Location

Borzan Polyclinic

Osijek, 31000, Croatia

Location

SurGal Clinic s.r.o.

Brno, 602 00, Czechia

Location

Nemocnice Ceske Budejovice a.s.

České Budějovice, 370 01, Czechia

Location

Gastroenterologie s.r.o.

Hradec Králové, 500 02, Czechia

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

CHU Amiens - Hopital Sud

Amiens, 80054, France

Location

CHU Dijon Bourgogne Hôpital François Mitterand

Dijon, 21000, France

Location

CH Dptal Les Oudairies

La Roche-sur-Yon, 85925, France

Location

CHRU de Lille - Hopital Claude Huriez

Lille, 59037, France

Location

Hopital Nord

Marseille, 13015, France

Location

Institut des MICI, Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

CHU Nice - Hopital de l'Archet 2

Nice, 06202, France

Location

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Robert Debre

Reims, 51092, France

Location

CHU de Rennes - Hopital de Pontchaillo

Rennes, 35033, France

Location

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, 42055, France

Location

Hôpital de Rangueil

Toulouse, 31400, France

Location

Universitaetsklinikum Jena

Jena, 77430, Germany

Location

Clinexpert Kft.

Budapest, 1033, Hungary

Location

Obudai Egeszsegugyi Centrum Kft.

Budapest, 1036, Hungary

Location

Pannonia Maganorvosi Centrum

Budapest, 1136, Hungary

Location

Clinexpert Gyongyos Kft

Gyöngyös, 3200, Hungary

Location

Clinfan Szolgaltato Kft.

Szekszárd, 7100, Hungary

Location

Jávorszky Ödön Kórház

Vác, 2600, Hungary

Location

Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat, 395002, India

Location

Gujarat Gastro and Vascular Hospital

Surat, Gujarat, 395009, India

Location

SR Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, 302006, India

Location

Shaare Zedek Medical Center

Jerusalem, Bayit Vegan, 9103102, Israel

Location

Ospedale Madonna delle Grazie

Matera, Basilicate, 75100, Italy

Location

Universita'degli Studi di Napoli Federico II

Naples, Campania, 80131, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

Location

ASST Rhodense - Ospedale di Rho

Rho, Lombardy, 20017, Italy

Location

Tsujinaka Hospital Kashiwanoha

Chiba, 277-0871, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Hidaka Coloproctology Clinic

Fukuoka, 839-0809, Japan

Location

Japanese Red Cross Takayama Hospital

Gifu, 506-8550, Japan

Location

Aoyama Clinic;GI Endoscopy & IBD Center

Hyōgo, 650-0015, Japan

Location

Kagawa Prefectural Central Hospital

Kagawa, 760-8557, Japan

Location

Sameshima Hospital

Kagoshima, 892-0846, Japan

Location

Gokeikai Ofuna Chuo Hospital

Kanagawa, 247-0056, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Ishida Clinic of IBD and Gastroenterology

Ōita, 870-0823, Japan

Location

Saga-ken Medical Centre Koseikan

Saga, 840-8571, Japan

Location

Saga University Hospital

Saga, 849-8501, Japan

Location

National Hospital Organization Shizuoka Medical Center

Shizuoka, 411-8611, Japan

Location

Matsuda Hospital

Shizuoka, 432-8061, Japan

Location

Kitasato University Kitasato Institute Hospital

Tokyo, 108-8642, Japan

Location

JCHO Tokyo Yamate Medical Center

Tokyo, 169-0073, Japan

Location

Tokai University Hachioji Hospital

Tokyo, 192-0032, Japan

Location

Yokohama City University Medical Center

Yokohama, 232-0024, Japan

Location

Boca Clinical Trials Mexico S.C. (Guadalajara)

Guadalajara, Jalisco, 44600, Mexico

Location

Accelerium S. de R.L. de C.V.

Monterrey, Nuevo León, 64000, Mexico

Location

Hospital General de Mexico

Mexico, Tlaxcala, 06726, Mexico

Location

Medical Care & Research SA de CV

Mérida, Yucatán, 97000, Mexico

Location

SPZOZ w ??cznej

??czna, 21-010, Poland

Location

Clinical Trials UMED Sp. z o. o.

?ód?, 92-213, Poland

Location

Centrum Medyczne "Medis"

Bydgoszcz, 85-229, Poland

Location

Centrum Medyczne Lukamed Joanna Luka-Wendrowska

Chojnice, 89-600, Poland

Location

Endo-Med Sp. z o.o.

Karczew, 05-480, Poland

Location

Allmedica Badania Kliniczne Sp z o.o. Sp K.

Nowy Targ, 34-400, Poland

Location

Wojewodzki Specjalistyczny Szpital w Olsztynie

Olsztyn, 10-561, Poland

Location

NZOZ Eskulap Pabianice

Pabianice, 95-200, Poland

Location

SOLUMED Centrum Medyczne

Późna, 60-529, Poland

Location

Centrum Medyczne "MEDYK"

Rzeszów, 35-326, Poland

Location

Kiepury Clinic

Sosnowiec, 41-200, Poland

Location

Gastromed Sp. z o.o.

Toru?, 87-100, Poland

Location

Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, 02-507, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-501, Poland

Location

Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?

Wroc?aw, 53-149, Poland

Location

Penta Hospitals Przychodnie, Wroclaw Wejherowska

Wroc?aw, 54-239, Poland

Location

Melita Medical

Wroclaw, 53-611, Poland

Location

ETG Zamosc

Zamo??, 22-400, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Hospital da Luz Lisboa

Lisbon, 1500-650, Portugal

Location

Centro Hospitalar do Algarve - Hospital de Portimao

Portimão, 8500-338, Portugal

Location

Hospital de Sao Joao

Porto, 4202-451, Portugal

Location

Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião

Santa Maria da Feira, 4520-211, Portugal

Location

Hospital Sao Teotonio

Viseu, 3504-509, Portugal

Location

University of Puerto Rico - Medical Science Campus

San Juan, 00936-5067, Puerto Rico

Location

Colentina Clinical Hospital

Bucharest, 020125, Romania

Location

Cantacuzino Clinical Hospital

Bucharest, 020475, Romania

Location

University Hospital Center Dr Dragisa Misovic - Dedinje

Belgrade, 11040, Serbia

Location

Clinical Hospital Center Zemun

Belgrade, 11080, Serbia

Location

University Hospital Medical Center Bezanijska Kosa

Belgrade, 11080, Serbia

Location

University Hospital Medical Center Zvezdara

Belgrade, 11120, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Clinical Center of Vojvodina

Novi Sad, 21137, Serbia

Location

Cliniq s.r.o.

Bratislava, 811 09, Slovakia

Location

Endomed, s.r.o.

Košice, 040 01, Slovakia

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, Changhua County, 50006, Taiwan

Location

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

Location

Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University

Bangkok, 10330, Thailand

Location

Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni

Bangkok, 10700, Thailand

Location

Liver Research Unit, Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University

Songkhla, 90110, Thailand

Location

Surin hospital

Surin, 32000, Thailand

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

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

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2031
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (2); CZ (3); CN (23); DK (1); HU (6); IT (5); AU (3); BE (3); TH (6); GB (3); CL (3); PL (18); IL (1); FR (13); BR (4); SE (6); PT (6); CA (1); BU (1); US (79); RO (2); JP (19); AR (2); SL (2); DE (1); ES (2); PR (1); CR (1); ME (4); IN (3)