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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Vixarelimab; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41500-300
      • CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
  • Pará
    • Pôrto Alegre, Pará, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre HCPA PPDS
  • São Paulo
    • Jaú, São Paulo, Brazil, 17201-130
      • Centro de Estudos Clinicos do Interior Paulista
    • Santo André, São Paulo, Brazil, 09080-110
      • Pesquisare Saude
    • São José do Rio Preto, São Paulo, Brazil, 15015-110
      • Kaiser Hospital Dia
• China
  • Guangzhou, China, 510080
    • The First Affiliated Hospital, Sun Yat-sen University
  • Guangzhou, China, 510655
    • The sixth affiliated hospital of Sun Yat-Sen University
  • Jinhua, China, 321000
    • Jinhua municipal central hospital
  • Nanchang, China
    • The First Affiliated Hospital of Nanchang University
  • Ningbo, China, 315000
    • The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
  • Wuhan, China, 430060
    • Renmin Hospital of Wuhan University
  • Wuhan, China, 430023
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology
• Czechia
  • Brno, Czechia, 602 00
    • SurGal Clinic s.r.o.
  • Hradec Králové, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o.
  • Olomouc, Czechia, 779 00
    • PreventaMed s.r.o.
  • Prague, Czechia, 150 00
    • Endohope klinika s. r.o.
• France
  • Saint-Etienne, France, 42055
    • CHU de Saint-Etienne - Hopital Nord
  • Vandœuvre-lès-Nancy, France, 54511
    • CHU de Nancy-Hopital Brabois Adulte
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Hopital L'Archet 2
• Greece
  • Palaió Fáliro, Greece, 175 62
    • Iatriko Palaiou Falirou
  • Attica
    • Athens, Attica, Greece, 106 76
      • Evangelismos General Hospital of Athens
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario A Gemelli-Rome
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Ospedale San Raffaele S.r.l. - PPDS
    • Rozzano, Lombardy, Italy, 20089
      • Istituto Clinico Humanitas
• Mexico
  • Jalisco
    • Tlajomulco de Zúñiga, Jalisco, Mexico, 45645
      • Centro Medico Clinico Quirurgico Especializado en Investigacion
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Medical Care & Research SA de CV
• Poland
  • ?ód?, Poland, 92-213
    • Clinical Trials UMED Sp. z o. o.
  • Bydgoszcz, Poland, 85-231
    • Medical Center Kermed
  • Knurów, Poland, 44-190
    • MZ Badania Slowik Zymla Sp.j.
  • Krakow, Poland, 31-506
    • Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
  • Nowy Targ, Poland, 34-400
    • Allmedica Badania Kliniczne sp. z o.o. sp.k.
  • Otwock, Poland, 05-400
    • Office of Jaroslaw Kierkus, Dr n Med
  • Szczecin, Poland, 71-685
    • Sonomed Sp. z o.o.
  • Tarnów, Poland, 33-100
    • Centrum Medyczne UNO-MED-Tarnow
  • Wadowice, Poland, 34-100
    • NZOZ FORMED sp zo.o.
  • Warsaw, Poland, 00-635
    • Centrum Zdrowia MDM
  • Wroc?aw, Poland, 52-210
    • Planetmed
  • Wroc?aw, Poland, 53-149
    • Przychodnia VISTAMED
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 54-144
      • EuroMediCare Szpital Specjalistyczny z Przychodni? we Wroc?awiu
  • Pomeranian Voivodeship
    • Sopot, Pomeranian Voivodeship, Poland, 81-756
      • Centrum Medyczne Euromedis Sp. z o.o.
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Clinical Hospital Center Zvezdara
  • Zrenjanin, Serbia, 23000
    • General Hospital Djordje Joanovic - Zrenjanin
• South Korea
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital
  • Daejeon, South Korea, 34943
    • The Catholic University of Korea Daejeon ST. Mary?s Hospital
  • Gangwon-do, South Korea, 26426
    • Yonsei University Wonju Severance Christian Hospital
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
• United States
  • California
    • Camarillo, California, United States, 93012
      • OM Research LLC - Camarillo - ClinEdge - PPDS
    • Los Angeles, California, United States, 90095
      • UCLA Clinical and Translational Research Center
    • Mission Hills, California, United States, 91345 1116
      • Facey Medical Foundation - Mission Hills
    • San Diego, California, United States, 92103-5639
      • Clinical Applications Laboratories, Inc.
  • Florida
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Center
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute, Inc.
    • Orlando, Florida, United States, 32835
      • Orlando Gastroenterology, P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
  • Michigan
    • Novi, Michigan, United States, 48377
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - PPDS
  • Mississippi
    • Southaven, Mississippi, United States, 38671
      • Delta Gastroenterology & Endoscopy Center
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Carolina Digestive Diseases
  • Ohio
    • Westlake, Ohio, United States, 44145
      • Gastro Intestinal Research Institute of Northern Ohio
  • Texas
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah - Health Sciences Center - PPDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vixarelimab Dose Regimen 1; Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.	Drug: Vixarelimab; Vixarelimab will be administered as per the schedule specified in the respective arms.; Other Names: RO7622888; KPL-716
Experimental: Vixarelimab Dose Regimen 2; Participants will receive vixarelimab SC during the induction period and the optional ATE period.	Drug: Vixarelimab; Vixarelimab will be administered as per the schedule specified in the respective arms.; Other Names: RO7622888; KPL-716
Placebo Comparator: Placebo; Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.	Drug: Vixarelimab; Vixarelimab will be administered as per the schedule specified in the respective arms.; Other Names: RO7622888; KPL-716; Drug: Placebo; Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Remission at Week 12	Clinical remission was defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore=0, & endoscopy subscore ≤ 1 (score of 1 modified to exclude friability). MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease: stool frequency (0=Normal number of stools, 1=1-2 more stools than normal, 2=3-4 more stools than normal, 3=5 or more stools than normal); rectal bleeding (0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed); centrally read endoscopy (0=Normal appearance of mucosa, 1=Mild disease [erythema, decreased vascular pattern], 2=Moderate disease [marked erythema, absent vascular pattern, friability, erosions], 3=Severe disease [spontaneous bleeding, ulceration]). Percentages have been rounded off.	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Response at Week 12	Clinical response was defined as decrease from baseline in mMS of ≥ 2 & ≥ 30% reduction from baseline and also decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease. Rectal bleeding scores are: 0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed. Percentages have been rounded off.	At Week 12
Percentage of Participants With Endoscopic Improvement at Week 12	Endoscopic improvement was defined as a Mayo endoscopy subscore of ≤ 1 (score of 1 modified to exclude friability). Endoscopy scores were based on interpretation by a blinded central reader. The Mayo Score consists of participant-reported outcomes (stool frequency, rectal bleeding), endoscopy, and clinician-reported outcome (Physician's Global Assessment) components. The Mayo endoscopy sub-score ranges from 0 to 3 (0= No inflammation; 1= Mild inflammation [erythema, decreased vascular pattern]; 2=Moderate inflammation [marked erythema, absent vascular pattern, and friability]; 3= Severe inflammation [ulceration and spontaneous bleeding]), with higher scores indicating more severe disease. Percentages have been rounded off.	At Week 12
Percentage of Participants With Endoscopic Remission at Week 12	Endoscopic remission was defined as a Mayo endoscopy subscore of 0. Endoscopy scores were based on interpretation by a blinded central reader. The Mayo Score consists of participant-reported outcomes (stool frequency, rectal bleeding), endoscopy, and clinician-reported outcome (Physician's Global Assessment) components. The Mayo endoscopy sub-score ranges from 0 to 3 (0= No inflammation; 1= Mild inflammation [erythema, decreased vascular pattern and mild friability]; 2=Moderate inflammation [marked erythema, absent vascular pattern, and friability]; 3= Severe inflammation [ulceration and spontaneous bleeding]), with higher scores indicating more severe disease. Percentages have been rounded off.	At Week 12
Number of Participants With Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; Any new disease or exacerbation of existing disease; Recurrence of an intermittent medical condition not present at baseline; Any deterioration in a laboratory value or other clinical test, associated with symptoms or leads to change in study treatment or concomitant treatment or discontinuation from study treatment; AEs related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.	Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Serum Concentration of Vixarelimab at Specified Timepoints		Weeks 0, 1, 2, 4, 8, 12, and study completion/early termination (up to 22 weeks)
Induction: Number of Participants With Anti-drug Antibodies (ADAs)	Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). The total number of participants who developed ADAs to vixarelimab was determined by summing the ADA-positive participants across all timepoints.	Baseline and post-baseline visits (up to 12 weeks)

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trial, Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; Gastrointestinal Disease; Colitis
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Colonic Diseases; Gastroenteritis; Gastrointestinal Diseases; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
• Other Study ID Numbers: GA44839; 2023-506655-19-00 (Ctis: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No