A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
NCT ID: NCT06137183
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
79 participants
INTERVENTIONAL
2024-05-01
2025-06-16
Brief Summary
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Detailed Description
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1. An induction period which will test the induction of clinical remission;
2. An optional active treatment extension (ATE) period which will explore durability of clinical response and remission in which all participants will receive vixarelimab.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vixarelimab Dose Regimen 1
Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.
Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
Vixarelimab Dose Regimen 2
Participants will receive vixarelimab SC during the induction period and the optional ATE period.
Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
Placebo
Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.
Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
Placebo
Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.
Interventions
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Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
Placebo
Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active UC, assessed by mMS
* Inadequate response, loss of response to, or intolerance to conventional or advanced therapies for UC
Exclusion Criteria
* Suspicion of ischemic, radiation, microscopic, or infectious colitis
* Prior colectomy
* Inadequate response or loss of response to previous treatment of UC with tofacitinib, upadacitinib, or other systemic janus kinase (JAK) inhibitor
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Gulf Coast Gatroenterology
Fairhope, Alabama, United States
OM Research LLC - Camarillo - ClinEdge - PPDS
Camarillo, California, United States
UCLA Clinical and Translational Research Center
Los Angeles, California, United States
Facey Medical Foundation - Mission Hills
Mission Hills, California, United States
Clinical Applications Laboratories, Inc.
San Diego, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Regenerate Primary Medical
Miami, Florida, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, United States
Orlando Gastroenterology, P.A.
Orlando, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Henry Ford Health System
Novi, Michigan, United States
Mayo Clinic - PPDS
Rochester, Minnesota, United States
Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi, United States
Strong Memorial Hospital
Rochester, New York, United States
Carolina Digestive Diseases
Greenville, North Carolina, United States
Ohio Gastroenterology and Liver Institute
Cincinnati, Ohio, United States
North Shore Gastroenterology
Westlake, Ohio, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
University of Utah - Health Sciences Center - PPDS
Salt Lake City, Utah, United States
CHU St Pierre (St Pierre)
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Cliagen Clinica de Atençao em Gastroenterologia, Especialidades e Nutriçao
Salvador, Estado de Bahia, Brazil
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
Brasília, Federal District, Brazil
Centro Digestivo de Curitiba
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre HCPA PPDS
Pôrto Alegre, Pará, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas da Faculdade de Medicina de Botucatu (HCFMB)
Botucatu, São Paulo, Brazil
Centro de Estudos Clinicos do Interior Paulista
Jaú, São Paulo, Brazil
Pesquisare Saude
Santo André, São Paulo, Brazil
Praxis Pesquisa Médica
Santo André, São Paulo, Brazil
Kaiser Hospital Dia
São José do Rio Preto, São Paulo, Brazil
Hospital Sirio-Libanes
São Paulo, São Paulo, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ
Rio de Janeiro, , Brazil
West China Hospital - Sichuan University
Chengdu, , China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
Qilu Hospital of Shandong University
Jinan, , China
Jinhua municipal central hospital
Jinhua, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
Ningbo, , China
Shengjing Hospital of China Medical University
Shenyang, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Tianjin Medical University General Hospital
Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Wuxi People's Hospital
Wuxi, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
SurGal Clinic s.r.o.
Brno, , Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
PreventaMed s.r.o.
Olomouc, , Czechia
Endohope klinika s. r.o.
Prague, , Czechia
CHU Nice - Hopital de l'Archet 2
Nice, , France
Hospices Civils de Lyon Centre hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Saint-Etienne - Hopital Nord
Saint-Etienne, , France
CHU de Nancy-Hopital Brabois Adulte
Vandœuvre-lès-Nancy, , France
Charite - Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Halle (Saale)
Halle, , Germany
Universitatsklinikum Schleswig-Holstein - Kiel
Kiel, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Evangelismos General Hospital of Athens
Athens, Attica, Greece
Sotiria General Hospital of Athens
Athens, , Greece
Alexandra Hospital
Athens, , Greece
University General Hospital of Heraklion
Heraklion, , Greece
Iatriko Palaiou Falirou
Palaió Fáliro, , Greece
Tzaneio General Hospital
Piraeus, , Greece
Rambam Health Care Campus
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Sheba Medical Center - PPDS
Ramat Gan, , Israel
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
Rome, Lazio, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Turin, Piedmont, Italy
Azienda Ospedaliero - Universitaria di Cagliari
Monserrato, Sardinia, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, Sicily, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, Italy
Hospital Puerta de Hierro Sur
Tlajomulco de Zúñiga, Jalisco, Mexico
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, Nuevo León, Mexico
Medical Care & Research SA de CV
Mérida, Yucatán, Mexico
Hospital Angeles Chihuahua
Chihuahua City, , Mexico
Melita Medical Sp. Z O. O.
Wroclaw, Lower Silesian Voivodeship, Poland
EuroMediCare Szpital Specjalistyczny z Przychodni? we Wroc?awiu
Wroclaw, Lower Silesian Voivodeship, Poland
Clinical Trials UMED Sp. z o. o.
?ód?, , Poland
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
?ód?, , Poland
Medical Center Kermed
Bydgoszcz, , Poland
Polimedica PTG Kielce
Kielce, , Poland
MZ Badania Slowik Zymla Sp.j.
Knurów, , Poland
Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
Krakow, , Poland
Allmedica Badania Kliniczne sp. z o.o. sp.k.
Nowy Targ, , Poland
Office of Jaroslaw Kierkus, Dr n Med
Otwock, , Poland
Endoskopia Sp. z o.o.
Sopot, , Poland
Sonomed Sp. z o.o.
Szczecin, , Poland
Centrum Medyczne UNO-MED-Tarnow
Tarnów, , Poland
NZOZ FORMED sp zo.o.
Wadowice, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
Warsaw, , Poland
PlanetMed
Wroc?aw, , Poland
Przychodnia VISTAMED
Wroc?aw, , Poland
Clinical Hospital Center Dragisa Misovic Dedinje
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa
Beograd-zemun, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Clinical Centre of Vojvodina
Nova Sad, , Serbia
General Hospital Djordje Joanovic - Zrenjanin
Zrenjanin, , Serbia
Inje university Haeundae Paik Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
The Catholic University of Korea Daejeon ST. Mary?s Hospital
Daejeon, , South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
E-Da Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Niaosong Dist., , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
The Royal London Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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2023-506655-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
GA44839
Identifier Type: -
Identifier Source: org_study_id
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