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

NCT06588855 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: GA453302024-513015-27-00
• Study Type: interventional
• Target: 350
• Locations: 29 countries
• Sites: 195

Brief Summary

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with 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 (1)

• Percentage of Participants with Clinical Remission

  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

Secondary Outcomes (17)

• Change in Partial Modified Mayo Score (pmMS)

  From 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

Placebo DRUG

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Placebo

Afimkibart DRUG

Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.

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

Afimkibart

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

Study Sites (199)

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

Dothan, Alabama, 36305, United States

RECRUITING

Mayo Clinic Hospital

Scottsdale, Arizona, 85259, United States

RECRUITING

Arizona Digestive Health, P.C (ADH)

Sun City, Arizona, 85351, United States

RECRUITING

Om Research LLC

Apple Valley, California, 92307, United States

RECRUITING

Valley View Internal Medicine

Garden Grove, California, 92845, United States

RECRUITING

Gastro Care Associates

Lancaster, California, 93534, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033-1057, United States

RECRUITING

Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education

Newport Beach, California, 92663, United States

RECRUITING

Stanford Medicine Outpatient Center

Redwood City, California, 94063, United States

RECRUITING

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

RECRUITING

Hi Tech and Global Research, LLC

Coral Gables, Florida, 33134, United States

RECRUITING

The Sister Life Research

Hialeah, Florida, 33013, United States

RECRUITING

LCC Medical Research Institute, LLC

Miami, Florida, 33126, United States

RECRUITING

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

RECRUITING

Ambert Medical Research

Miami, Florida, 33176, United States

WITHDRAWN

Integrity Trials LLC

Orlando, Florida, 32807, United States

RECRUITING

Digestive and Liver Center of Florida

Orlando, Florida, 32825, United States

RECRUITING

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

RECRUITING

University of South Florida School of Medicine Morsani Center for Advanced Health Care

Tampa, Florida, 33612, United States

RECRUITING

Guardian Angel Research Center, LLC

Tampa, Florida, 33614, United States

RECRUITING

Santos Research Center, CORP

Tampa, Florida, 33615, United States

RECRUITING

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Randomize Now, LLC

Atlanta, Georgia, 30308, United States

RECRUITING

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

RECRUITING

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201, United States

RECRUITING

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, 83404, United States

RECRUITING

Illinois Gastroenterology Group-Glenview powered by GI Alliance

Glenview, Illinois, 60026, United States

RECRUITING

GI Alliance - Gurnee

Gurnee, Illinois, 60031, United States

RECRUITING

Gastro Health Partners, LLC

New Albany, Indiana, 47150, United States

RECRUITING

Kansas Gastroenterology, LLC under Clinical Trials Network

Wichita, Kansas, 67226, United States

RECRUITING

One GI: GHP - Gastroenterology Health Partners Louisville

Louisville, Kentucky, 40218, United States

RECRUITING

Louisiana Research Center - GastroIntestinal Associates

Shreveport, Louisiana, 71105, United States

RECRUITING

Allied Gastrointestinal Associates, PA

Flowood, Mississippi, 39232, United States

RECRUITING

Delta Gastroenterology & Endoscopy Center

Southaven, Mississippi, 38671, United States

RECRUITING

Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Ellipsis Research Group

Brooklyn, New York, 11215, United States

RECRUITING

NYU Inflammatory Bowel Disease Center

New York, New York, 10016, United States

RECRUITING

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

DiGiovanna Inst for Med Ed&Res

North Massapequa, New York, 11758, United States

RECRUITING

Queens Village Medical Care

Queens Village, New York, 11428, United States

RECRUITING

Gastroenterology Group Of Rochester, LLP

Rochester, New York, 14618, United States

RECRUITING

James J Peters Veterans Administration Medical Center - NAVREF

The Bronx, New York, 10468, United States

RECRUITING

Charlotte Gastroenterology and Hepatology, P.L.L.C

Charlotte, North Carolina, 28207, United States

RECRUITING

Omega Research North Carolina, LLC

Fuquay-Varina, North Carolina, 27526, United States

RECRUITING

Peters Medical Research (PMR), LLC

High Point, North Carolina, 27260, United States

RECRUITING

Dayton Gastroenterology, Inc.

Beavercreek, Ohio, 45440, United States

RECRUITING

University of Cincinnati Hospital

Cincinnati, Ohio, 45267, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio Gastroenterology Group

Columbus, Ohio, 43202, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Gastro Intestinal Research Institute of Northern Ohio

Westlake, Ohio, 44145, United States

RECRUITING

Frontier Clinical Re search, LLC

Uniontown, Pennsylvania, 15401, United States

RECRUITING

University Gastroenterology

Providence, Rhode Island, 02904, United States

RECRUITING

Gastroenterology Associates

Greenville, South Carolina, 29607, United States

RECRUITING

Gastro One

Cordova, Tennessee, 38018, United States

RECRUITING

Uni of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

GI Alliance

Garland, Texas, 75044, United States

RECRUITING

Amel Med LLC

Georgetown, Texas, 78628, United States

RECRUITING

Cano Medical Center

Harlingen, Texas, 78550, United States

RECRUITING

Texas Digestive Specialists

Harlingen, Texas, 78550, United States

RECRUITING

Integrity Advanced Therapeutics PLLC

Houston, Texas, 77090, United States

NOT YET RECRUITING

GI Alliance - Bay Area Gastroenterology

Lubbock, Texas, 79410, United States

RECRUITING

TDDC dba GI Alliance Research

Mansfield, Texas, 76063, United States

NOT YET RECRUITING

Southern Star Research Institute, LLC.

San Antonio, Texas, 78229, United States

RECRUITING

Baylor Scott and White Medical Center

Temple, Texas, 76508, United States

RECRUITING

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

RECRUITING

University of Texas Health Center at Tyler

Tyler, Texas, 75708, United States

RECRUITING

TDDC GI Alliance research Webster

Webster, Texas, 77598, United States

RECRUITING

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

RECRUITING

Emeritas Research Group

Lansdowne Town Center, Virginia, 20176, United States

RECRUITING

Gastroenterology Consultants of SWVA

Roanoke, Virginia, 24018, United States

RECRUITING

Hospital Britanico

Ciudad Autonoma Bs As, C1280AEB, Argentina

RECRUITING

Instituto Medico CER

Quilmes, B1878DVB, Argentina

RECRUITING

Macquarie University Hospital

Macquarie Park, New South Wales, 2109, Australia

ACTIVE NOT RECRUITING

Coral Sea Clinical Research Institute

Mackay, Queensland, 4740, Australia

WITHDRAWN

Footscray Hospital

Footscray, Victoria, 3011, Australia

WITHDRAWN

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

ACTIVE NOT RECRUITING

Ordensklinikum Linz Barmherzige Schwestern

Linz, 4010, Austria

ACTIVE NOT RECRUITING

Klinikum Wels-Grieskirchen

Wels, 4600, Austria

WITHDRAWN

AZORG Campus Aalst-Moorselbaan

Aalst, 9300, Belgium

WITHDRAWN

CHU St Pierre (St Pierre)

Brussels, 1000, Belgium

ACTIVE NOT RECRUITING

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

ACTIVE NOT RECRUITING

AZ Oostende

Ostend, 8400, Belgium

WITHDRAWN

Instituto Lobus Unimed Volta Redonda

Volta Redonda, Rio de Janeiro, 27258-000, Brazil

RECRUITING

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-000, Brazil

RECRUITING

Newdata Clinical Trials

Aracaju, Sergipe, 49055-000, Brazil

RECRUITING

CECIP - Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, 17210-190, Brazil

RECRUITING

Hospital Sírio-Libanês

São Paulo, São Paulo, 01308-050, Brazil

RECRUITING

Centro Paulista de Investigacao Clinica - CEPIC

São Paulo, São Paulo, 04266-010, Brazil

RECRUITING

Second Multiprofile Hospital For Active Treatment-Sofia

Sofia Town, Sofia, 1202, Bulgaria

WITHDRAWN

MC " Sveti Ivan Rilski Chudotvorets- 2010

Plovdiv, 4003, Bulgaria

RECRUITING

"City Clinic UMHAC" EOOD

Sofia, 1407, Bulgaria

RECRUITING

Barrie GI Associates

Barrie, Ontario, L4M 7G1, Canada

RECRUITING

GNRR Digestive Clinics and Research Center Inc.

Brampton, Ontario, L6S 0E2, Canada

RECRUITING

London Health Sciences Centre Uni Campus

London, Ontario, N6A 5A5, Canada

RECRUITING

TIDHI Innovation Inc.

Toronto, Ontario, M6A 3B4, Canada

RECRUITING

CIUSSS-de-l?Est-de-l?Île-de-Montréal

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Centro de Investigación Clínica UC-CICUC

Santiago, 8330034, Chile

RECRUITING

Beijing No.6 Hospital

Beijing, Beijing Municipality, 100007, China

RECRUITING

The First Affilliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

Third Xiangya Hospital Centrel South University

Changsha, 410013, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, 610041, China

RECRUITING

Guangzhou First People's Hospital

Guangzhou, 510180, China

RECRUITING

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510260, China

RECRUITING

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, 310016, China

RECRUITING

Huizhou Central People's Hospital

Huizhou, 516001, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, 330008, China

RECRUITING

The First Affiliate Hospital of Guangxi Medical University

Nanning, 530021, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, 315000, China

RECRUITING

The Affiliated Hospital of Medical College Qingdao University

Qingdao, 266000, China

RECRUITING

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, 110004, China

RECRUITING

First Affiliated Hospital of Soochow University

Suzhou, 215006, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, 361003, China

RECRUITING

Zhongshan Hospital Xiamen University

Xiamen, 361004, China

RECRUITING

Borzan Polyclinic

Osijek, 31000, Croatia

RECRUITING

Clinical Hospital Center Sestre Milosrdnice

Zagreb, 10000, Croatia

RECRUITING

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 500 12, Czechia

RECRUITING

Fakultni nemocnice Ostrava

Ostrava - Poruba, 708 52, Czechia

RECRUITING

ISCARE a.s.

Prague, 170 04, Czechia

RECRUITING

Ålborg Universitets Hospital

Aalborg, 9000, Denmark

RECRUITING

CHU Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170, France

RECRUITING

CHU Clermont Ferrand - Hôtel Dieu

Clermont-Ferrand, 63000, France

RECRUITING

Hôpital Henri Mondor

Créteil, 94000, France

RECRUITING

Polyclinique Grand Sud

Nîmes, 30900, France

RECRUITING

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

WITHDRAWN

Medizinisches Zentrum Klinikum Lueneburg

Lüneburg, 21339, Germany

RECRUITING

Klinikum Ernst von Bergmann

Potsdam, 14467, Germany

WITHDRAWN

Észak-Pesti Centrumkórház-Honvédkórház

Budapest, 1062, Hungary

WITHDRAWN

Semmelweis Egyetem

Budapest, 1082, Hungary

RECRUITING

Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

Debrecen, 4025, Hungary

RECRUITING

Fejer Varmegyei Szent György Egyetemi Oktatokorhaz

Székesfehérvár, 8000, Hungary

RECRUITING

Vas-Oxy Egeszsegugyi Kft

Szombathely, 9700, Hungary

RECRUITING

Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat, 395002, India

RECRUITING

Gujarat Gastro and Vascular Hospital

Surat, Gujarat, 395009, India

RECRUITING

Kingsway Hospital

Nagpur (urban), Maharashtra, 440001, India

COMPLETED

MIDAS Multispeciality Hospital

Nagpur (urban), Maharashtra, 440018, India

RECRUITING

Sahyadri Super Speciality Hospital

Nashik, Maharashtra, 422001, India

RECRUITING

SR Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, 302006, India

RECRUITING

SMS Superspeciality Hospital

Jaipur, Rajasthan, 302007, India

RECRUITING

AIG Hospitals

Gachibowli, Telangana, 500032, India

RECRUITING

Yashoda Hospitals

Secunderabad, Telangana, 500003, India

RECRUITING

Soroka Medical Center

Beersheba, 8410101, Israel

RECRUITING

The Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

RECRUITING

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti

Bologna, Emilia-Romagna, 40138, Italy

WITHDRAWN

Policlinico Universitario Campus Biomedico Di Roma

Rome, Lazio, 00128, Italy

RECRUITING

Ospedale Isola Tiberina Gemelli

Rome, Lazio, 00186, Italy

RECRUITING

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, 25123, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

Azienda Ospedaliera San Gerardo di Monza

Monza MI, Lombardy, 20900, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, 20089, Italy

RECRUITING

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Veneto, 37024, Italy

RECRUITING

Boca Clinical Trials Mexico S.C. (Cd. Mexico)

Miguel Hidalgo, Mexico CITY (federal District), 01120, Mexico

RECRUITING

FAICIC S de R.L. de C.V

Veracruz, 91900, Mexico

RECRUITING

ETZ Elisabeth

Tilburg, 5022 GC, Netherlands

ACTIVE NOT RECRUITING

Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.

?ód?, 93-357, Poland

ACTIVE NOT RECRUITING

Gastromed Kralisz, Romatowski, Stachurska sp.j.

Bia?ystok, 15-322, Poland

WITHDRAWN

Medical Center Kermed

Bydgoszcz, 85-231, Poland

RECRUITING

Szpital Miejski sw. Jana Paw?a II w Elblagu

Elblag, 82-300, Poland

RECRUITING

Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska

Grudzadz, 86-300, Poland

WITHDRAWN

Osrodek Badan Klinicznych Bd Research

I?awa, 14-200, Poland

RECRUITING

MZ Badania Slowik Zymla Sp.j.

Knurów, 44-190, Poland

ACTIVE NOT RECRUITING

Centrum Medyczne Promed

Krakow, 31-513, Poland

ACTIVE NOT RECRUITING

Medrise sp z o.o

Lublin, 20-582, Poland

RECRUITING

Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

Poznan, 61-731, Poland

RECRUITING

EMC Instytut Medyczny SA

Późna, 60-309, Poland

RECRUITING

Gabinety Lekarskie Rivermed

Późna, 61-441, Poland

RECRUITING

Endoskopia Sp. z o.o.

Sopot, 81-756, Poland

RECRUITING

Sonomed Sp. z o.o.

Szczecin, 71-685, Poland

RECRUITING

Centrum Zdrowia-MDM

Warsaw, 00-189, Poland

RECRUITING

Medon Clinical Research sp. z o.o

Warsaw, 02-679, Poland

RECRUITING

Vivamed Spolka Z Ograniczona Odpowiedzialnoscia

Warsaw, 03-580, Poland

RECRUITING

PlanetMed sp. z o.o.

Wroc?aw, 52-210, Poland

RECRUITING

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

RECRUITING

Hospital de Braga

Braga, 4710-243, Portugal

RECRUITING

Hospital da Luz Lisboa

Lisbon, 1500-650, Portugal

RECRUITING

Centro Hospitalar do Algarve - Hospital de Portimao

Portimão, 8500-338, Portugal

RECRUITING

Hospital de Sao Joao

Porto, 4202-451, Portugal

RECRUITING

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

Santa Maria da Feira, 4520-211, Portugal

RECRUITING

Hospital Sao Teotonio

Viseu, 3504-509, Portugal

RECRUITING

Klinical Investigations Group LLC

San Juan, 00909, Puerto Rico

RECRUITING

General Hospital "Djordje Joanovic"

Zrenjanin, 23000, Serbia

RECRUITING

KM Management spol. s r.o.

Nitra, 949 01, Slovakia

WITHDRAWN

Accout Center s.r.o.

Šahy, 936 01, Slovakia

WITHDRAWN

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

ACTIVE NOT RECRUITING

Hospital Clinico Univ. Lozano Blesa

Zaragoza, 50009, Spain

WITHDRAWN

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

ACTIVE NOT RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

Burapha University Hospital

Chon Buri, 20131, Thailand

RECRUITING

Sunpasitthiprasong Hospital

Ubonratchathani, 34000, Thailand

RECRUITING

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

RECRUITING

Bronglais General Hospital

Llanrhystud, SY23 1ER, United Kingdom

RECRUITING

King College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Peterborough City Hospital

Peterborough, PE 3 9GZ, United Kingdom

WITHDRAWN

Stepping Hill Hospital

Stockport, SK2 7JE, United Kingdom

RECRUITING

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GA45330 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

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: December 11, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (6); CZ (3); HU (5); PR (1); SE (1); CN (18); CA (5); GB (6); CL (1); IT (8); IN (9); PL (19); AU (2); NL (1); ME (2); IL (2); CR (2); PT (6); AR (2); BU (3); TH (3); TW (1); ES (3); DE (3); SL (2); US (71); BE (4); FR (5); DK (1)