Clinical trial NCT06137183: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Official title: A Phase II, Multicenter Induction Study With an Active Treatment Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Patients With Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Inflammatory Bowel Disease
Gastrointestinal Disease
Ulcerative Colitis
Colitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 advanced therapies for UC

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 with tofacitinib, upadacitinib, or other systemic janus kinase (JAK) inhibitor

Primary outcomes:
measure: Proportion of Participants With Clinical Remission
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of Participants With Clinical Response
timeFrame: Week 12
measure: Proportion of Participants With Endoscopic Improvement
timeFrame: Week 12
measure: Proportion of Participants With Endoscopic Remission
timeFrame: Week 12
measure: Number of Participants With Adverse Events (AEs) by Severity
timeFrame: Up to Week 56
measure: Serum Concentration of Vixarelimab
timeFrame: Up to Week 56
measure: Proportion of Participants With Anti-drug Antibodies (ADAs) to Vixarelimab
timeFrame: Up to Week 56
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Gulf Coast Gatroenterology
state: Alabama
city: Camarillo
country: United States
facility: OM Research LLC - Camarillo - ClinEdge - PPDS
state: California
city: Los Angeles
country: United States
facility: UCLA Clinical and Translational Research Center
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation - Mission Hills
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc.
state: California
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: Regenerate Primary Medical
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Orlando
country: United States
facility: Orlando Gastroenterology, P.A.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - PPDS
state: Minnesota
city: Southaven
country: United States
facility: Delta Gastroenterology & Endoscopy Center
state: Mississippi
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Cincinnati
country: United States
facility: Ohio Gastroenterology and Liver Institute
state: Ohio
city: Westlake
country: United States
facility: North Shore Gastroenterology
state: Ohio
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Health Sciences Center - PPDS
state: Utah
city: Bruxelles
country: Belgium
facility: CHU St Pierre (St Pierre)
city: Leuven
country: Belgium
facility: UZ Leuven
city: Salvador
country: Brazil
facility: Cliagen Clinica de Atençao em Gastroenterologia, Especialidades e Nutriçao
state: Bahia
city: Brasilia
country: Brazil
facility: L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
state: Distrito Federal
city: Curitiba
country: Brazil
facility: Centro Digestivo de Curitiba
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre HCPA PPDS
state: Pará
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Botucatu (HCFMB)
state: São Paulo
city: JAU
country: Brazil
facility: Centro de Estudos Clinicos do Interior Paulista
state: São Paulo
city: Santo Andre
country: Brazil
facility: Pesquisare Saude
state: São Paulo
city: Santo Andre
country: Brazil
facility: Praxis Pesquisa Médica
state: São Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Kaiser Hospital Dia
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Sirio-Libanes
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Clementino Fraga Filho - UFRJ
city: Chengdu City
country: China
facility: West China Hospital - Sichuan University
city: Guangzhou City
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Jinhua City
country: China
facility: Jinhua municipal central hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Ningbo City
country: China
facility: The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
city: ShenYang
country: China
facility: Shengjing Hospital of China Medical University
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Suzhou City
country: China
facility: The First Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan City
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Brno
country: Czechia
facility: SurGal Clinic s.r.o.
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Olomouc
country: Czechia
facility: PreventaMed s.r.o.
city: Praha
country: Czechia
facility: Endohope klinika s. r.o.
city: Nice Cedex 3
country: France
facility: CHU Nice - Hopital de l'Archet 2
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon Centre hospitalier Lyon Sud
city: Saint Etienne
country: France
facility: CHU de Saint-Etienne - Hopital Nord
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy-Hopital Brabois Adulte
city: Berlin
country: Germany
facility: Charite - Campus Benjamin Franklin
city: Halle
country: Germany
facility: Universitaetsklinikum Halle (Saale)
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein - Kiel
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attiki
city: Athens
country: Greece
facility: Sotiria General Hospital of Athens
city: Athens
country: Greece
facility: Alexandra Hospital
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Palaio Faliro
country: Greece
facility: Iatriko Palaiou Falirou
city: Piraeus
country: Greece
facility: Tzaneio General Hospital
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center - PPDS
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli-Rome
state: Lazio
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
state: Piemonte
city: Monserrato
country: Italy
facility: Azienda Ospedaliero - Universitaria di Cagliari
state: Sardegna
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
state: Sicilia
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
state: Veneto
city: Busan
country: Korea, Republic of
facility: Inje university Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea Daejeon ST. Mary?s Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Tlajomulco de Zúñiga
country: Mexico
facility: Hospital Puerta de Hierro Sur
state: Jalisco
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V. - PPDS
state: Nuevo LEON
city: Mérida
country: Mexico
facility: Medical Care & Research SA de CV
state: Yucatan
city: Chihuahua
country: Mexico
facility: Hospital Angeles Chihuahua
city: Wroclaw
country: Poland
facility: EuroMediCare Szpital Specjalistyczny z Przychodni? we Wroc?awiu
state: Dolnoslaskie
city: ?ód?
country: Poland
facility: Clinical Trials UMED Sp. z o. o.
city: ?ód?
country: Poland
facility: Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
city: Bydgoszcz
country: Poland
facility: Medical Center Kermed
city: Kielce
country: Poland
facility: Polimedica PTG Kielce
city: Knurów
country: Poland
facility: MZ Badania Slowik Zymla Sp.j.
city: Kraków
country: Poland
facility: Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
city: Nowy Targ
country: Poland
facility: Allmedica Badania Kliniczne sp. z o.o. sp.k.
city: Otwock
country: Poland
facility: Office of Jaroslaw Kierkus, Dr n Med
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Szczecin
country: Poland
facility: Sonomed Sp. z o.o.
city: Tarnów
country: Poland
facility: Centrum Medyczne UNO-MED-Tarnow
city: Wadowice
country: Poland
facility: NZOZ FORMED sp zo.o.
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
city: Wroc?aw
country: Poland
facility: Melita Medical
city: Wroc?aw
country: Poland
facility: PlanetMed
city: Wroc?aw
country: Poland
facility: Przychodnia VISTAMED
city: Beograd
country: Serbia
facility: University Clinical Center of Serbia -PPDS
state: Belgrade
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dragisa Misovic Dedinje
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Beograd-zemun
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Nova Sad
country: Serbia
facility: Clinical Centre of Vojvodina
city: Zemun
country: Serbia
facility: Clinical Hospital Centre Zemun
city: Zrenjanin
country: Serbia
facility: General Hospital Djordje Joanovic - Zrenjanin
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Niaosong Dist.
country: Taiwan
facility: Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trial
role: STUDY_DIRECTOR
References: