A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Last updated: April 23, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Ulcerative Colitis

Ulcers

Colic

Treatment

Placebo

Vixarelimab

Clinical Study ID

NCT06137183
GA44839
2023-506655-19-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of UC for at least 3 months

  • Moderately to severely active UC, assessed by mMS

  • Inadequate response, loss of response to, or intolerance to conventional or advancedtherapies for UC

Exclusion

Exclusion Criteria:

  • Diagnosis of Crohn's disease or indeterminate colitis

  • Suspicion of ischemic, radiation, microscopic, or infectious colitis

  • Prior colectomy

  • Inadequate response or loss of response to previous treatment of UC withtofacitinib, upadacitinib, or other systemic janus kinase (JAK) inhibitor

Study Design

Total Participants: 79
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 01, 2024
Estimated Completion Date:
February 29, 2028

Study Description

This study consists of two periods:

  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.

Connect with a study center

  • CHU St Pierre (St Pierre)

    Brussels, 1000
    Belgium

    Site Not Available

  • CHU St Pierre (St Pierre)

    Bruxelles, 1000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Cliagen Clinica de Atençao em Gastroenterologia, Especialidades e Nutriçao

    Salvador, Bahia 41500-300
    Brazil

    Site Not Available

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    Brasilia, Distrito Federal 70200-730
    Brazil

    Site Not Available

  • Centro Digestivo de Curitiba

    Curitiba, Paraná 80430-160
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará 90035-903
    Brazil

    Site Not Available

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, Rio Grande Do Sul 90035-001
    Brazil

    Site Not Available

  • Hospital das Clinicas da Faculdade de Medicina de Botucatu (HCFMB)

    Botucatu, São Paulo 18618-687
    Brazil

    Site Not Available

  • Centro de Estudos Clinicos do Interior Paulista

    JAU, São Paulo 17201-130
    Brazil

    Site Not Available

  • Pesquisare Saude

    Santo Andre, São Paulo 09080-110
    Brazil

    Site Not Available

  • Praxis Pesquisa Médica

    Santo Andre, São Paulo 09090-790
    Brazil

    Site Not Available

  • Kaiser Hospital Dia

    Sao Jose Do Rio Preto, São Paulo 15015-110
    Brazil

    Site Not Available

  • Hospital Sirio-Libanes

    Sao Paulo, São Paulo 01308-050
    Brazil

    Site Not Available

  • Hospital Universitario Clementino Fraga Filho - UFRJ

    Rio de Janeiro, 21941-913
    Brazil

    Site Not Available

  • West China Hospital - Sichuan University

    Chengdu City, 610047
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510655
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou City, 510080
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, 250012
    China

    Site Not Available

  • Jinhua municipal central hospital

    Jinhua,
    China

    Site Not Available

  • Jinhua municipal central hospital

    Jinhua City, 321000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang City, 330008
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)

    Ningbo City, 315000
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    ShenYang, 110004
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 050000
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou City, 215006
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, 430060
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan City, 430023
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, 214023
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004
    China

    Site Not Available

  • SurGal Clinic s.r.o.

    Brno, 602 00
    Czechia

    Site Not Available

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • PreventaMed s.r.o.

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Endohope klinika s. r.o.

    Praha, 150 00
    Czechia

    Site Not Available

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202
    France

    Site Not Available

  • CHU Nice - Hopital de l'Archet 2

    Nice Cedex 3, 06202
    France

    Site Not Available

  • Hospices Civils de Lyon Centre hospitalier Lyon Sud

    Pierre Benite, 69310
    France

    Site Not Available

  • CHU de Saint-Etienne - Hopital Nord

    Saint Etienne, 42055
    France

    Site Not Available

  • CHU de Nancy-Hopital Brabois Adulte

    Vandoeuvre, 54511
    France

    Site Not Available

  • CHU de Nancy-Hopital Brabois Adulte

    Vandoeuvre les Nancy, 54511
    France

    Site Not Available

  • Charite - Campus Benjamin Franklin

    Berlin, 12203
    Germany

    Site Not Available

  • Universitaetsklinikum Halle (Saale)

    Halle, 06120
    Germany

    Site Not Available

  • Universitaetsklinikum Halle (Saale); Universitatsklinik und Poliklinik fur Innere Medizin I

    Halle, 06120
    Germany

    Active - Recruiting

  • Universitatsklinikum Schleswig-Holstein - Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Evangelismos General Hospital of Athens

    Athens, Attiki 106 76
    Greece

    Site Not Available

  • Alexandra Hospital

    Athens, 115 28
    Greece

    Site Not Available

  • Iatriko Palaiou Falirou

    Athens, 175 62
    Greece

    Active - Recruiting

  • Sotiria General Hospital of Athens

    Athens, 115 27
    Greece

    Site Not Available

  • Sotiria General Hospital of Athens; 3rd Department of Internal Medicine

    Athens, 115 27
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion

    Heraklio, 711 10
    Greece

    Site Not Available

  • University General Hospital of Heraklion

    Heraklion, 711 10
    Greece

    Site Not Available

  • Iatriko Palaiou Falirou

    Palaio Faliro, 175 62
    Greece

    Site Not Available

  • Tzaneio General Hospital

    Piraeus, 185 36
    Greece

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 31096
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba, 44281
    Israel

    Site Not Available

  • Meir Medical Center; Gastroenterology

    Kfar Saba, 4428100
    Israel

    Active - Recruiting

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621
    Israel

    Site Not Available

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

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Ospedale San Raffaele S.r.l. - PPDS

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • Istituto Clinico Humanitas; Biobanca

    Rozzano, Lombardia 20089
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, Piemonte 10128
    Italy

    Site Not Available

  • Azienda Ospedaliero - Universitaria di Cagliari

    Monserrato, Sardegna 09042
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, Sicilia 90146
    Italy

    Site Not Available

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto 37024
    Italy

    Site Not Available

  • Inje university Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Kosin University Gospel Hospital

    Busan, 49267
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Daejeon ST. Mary?s Hospital

    Daejeon, 34943
    Korea, Republic of

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-do, 26426
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 6351
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Hospital Puerta de Hierro Sur

    Tlajomulco de Zúñiga, Jalisco 45645
    Mexico

    Site Not Available

  • Accelerium, S. de R.L. de C.V. - PPDS

    Monterrey, Nuevo LEON 64000
    Mexico

    Site Not Available

  • Medical Care & Research SA de CV

    Mérida, Yucatan 97070
    Mexico

    Site Not Available

  • Hospital Angeles Chihuahua

    Chihuahua, 31238
    Mexico

    Site Not Available

  • EuroMediCare Szpital Specjalistyczny z Przychodni? we Wroc?awiu

    Wroclaw, Dolnoslaskie 54-144
    Poland

    Site Not Available

  • Clinical Trials UMED Sp. z o. o.

    ?ód?, 92-213
    Poland

    Site Not Available

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

    ?ód?, 93-357
    Poland

    Site Not Available

  • Medical Center Kermed

    Bydgoszcz, 85-231
    Poland

    Site Not Available

  • Polimedica PTG Kielce

    Kielce, 25-355
    Poland

    Site Not Available

  • MZ Badania Slowik Zymla Sp.j.

    Knurów, 44-190
    Poland

    Site Not Available

  • Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

    Kraków, 31-506
    Poland

    Site Not Available

  • Allmedica Badania Kliniczne sp. z o.o. sp.k.

    Nowy Targ, 34-400
    Poland

    Site Not Available

  • Office of Jaroslaw Kierkus, Dr n Med

    Otwock, 05-400
    Poland

    Site Not Available

  • Endoskopia Sp. z o.o.

    Sopot, 81-756
    Poland

    Site Not Available

  • Sonomed Sp. z o.o.

    Szczecin, 71-685
    Poland

    Site Not Available

  • Centrum Medyczne UNO-MED-Tarnow

    Tarnów, 33-100
    Poland

    Site Not Available

  • NZOZ FORMED sp zo.o.

    Wadowice, 34-100
    Poland

    Site Not Available

  • Centrum Zdrowia MDM

    Warszawa, 00-635
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

    Warszawa, 03-580
    Poland

    Site Not Available

  • Melita Medical

    Wroc?aw, 50-449
    Poland

    Site Not Available

  • PlanetMed

    Wroc?aw, 52-210
    Poland

    Site Not Available

  • Przychodnia VISTAMED

    Wroc?aw, 53-149
    Poland

    Site Not Available

  • University Clinical Center of Serbia -PPDS

    Beograd, Belgrade 112117
    Serbia

    Site Not Available

  • Clinical Hospital Center Dragisa Misovic Dedinje

    Belgrade, 11000
    Serbia

    Site Not Available

  • Military Medical Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Hospital Center Bezanijska Kosa

    Beograd-zemun, 11080
    Serbia

    Site Not Available

  • Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Clinical Centre of Vojvodina

    Nova Sad, 21000
    Serbia

    Site Not Available

  • Clinical Hospital Centre Zemun

    Zemun, 11080
    Serbia

    Site Not Available

  • General Hospital Djordje Joanovic - Zrenjanin

    Zrenjanin, 23000
    Serbia

    Site Not Available

  • E-Da Hospital

    Kaohsiung, 82445
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital

    Niaosong Dist., 83301
    Taiwan

    Site Not Available

  • China Medical University Hospital

    North Dist., 40402
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital

    Tainan, 83301
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 00100
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei City, 112
    Taiwan

    Site Not Available

  • Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Site Not Available

  • The Royal London Hospital

    London, E1 4AT
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Gulf Coast Gatroenterology

    Fairhope, Alabama 36532
    United States

    Site Not Available

  • OM Research LLC - Camarillo - ClinEdge - PPDS

    Camarillo, California 93012
    United States

    Site Not Available

  • UCLA Clinical and Translational Research Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Facey Medical Foundation - Mission Hills

    Mission Hills, California 91345 1116
    United States

    Site Not Available

  • Clinical Applications Laboratories, Inc.

    San Diego, California 92103-5639
    United States

    Site Not Available

  • Regenerate Primary Medical

    Miami, Florida 33155
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Advanced Research Institute, Inc.

    New Port Richey, Florida 34653
    United States

    Site Not Available

  • Orlando Gastroenterology, P.A.

    Orlando, Florida 32835
    United States

    Site Not Available

  • Regenerate Primary Medical

    South Miami, Florida 33143
    United States

    Site Not Available

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Henry Ford Health System

    Novi, Michigan 48377
    United States

    Site Not Available

  • Henry Ford Health System; Columbus Center

    Novi, Michigan 48377
    United States

    Active - Recruiting

  • Mayo Clinic - PPDS

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Delta Gastroenterology & Endoscopy Center

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • Strong Memorial Hospital

    Rochester, New York 14642
    United States

    Site Not Available

  • Carolina Digestive Diseases

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Ohio Gastroenterology and Liver Institute

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • North Shore Gastroenterology

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Tyler Research Institute, LLC

    Tyler, Texas 75701
    United States

    Site Not Available

  • University of Utah - Health Sciences Center - PPDS

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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