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

NCT06137183 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: GA448392023-506655-19-00
• Study Type: interventional
• Target: 79
• Locations: 12 countries
• Sites: 65

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.

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel Disease; Gastrointestinal Disease; Ulcerative Colitis; Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of Participants With Clinical Response at Week 12

  At Week 12

• Percentage of Participants With Endoscopic Improvement at Week 12

  At Week 12

• Percentage of Participants With Endoscopic Remission at Week 12

  At Week 12

• Number of Participants With Adverse Events (AEs)

  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)

Study Arms (3)

Vixarelimab Dose Regimen 1

EXPERIMENTAL

Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.

Drug: Vixarelimab

Vixarelimab Dose Regimen 2

EXPERIMENTAL

Participants will receive vixarelimab SC during the induction period and the optional ATE period.

Drug: Vixarelimab

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.

Drug: Vixarelimab; Drug: Placebo

Interventions

Vixarelimab DRUG

Vixarelimab will be administered as per the schedule specified in the respective arms.

Also known as: RO7622888; KPL-716

Placebo; Vixarelimab Dose Regimen 1; Vixarelimab Dose Regimen 2

Placebo DRUG

Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (65)

OM Research LLC - Camarillo - ClinEdge - PPDS

Camarillo, California, 93012, United States

Location

UCLA Clinical and Translational Research Center

Los Angeles, California, 90095, United States

Location

Facey Medical Foundation - Mission Hills

Mission Hills, California, 91345 1116, United States

Location

Clinical Applications Laboratories, Inc.

San Diego, California, 92103-5639, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653, United States

Location

Orlando Gastroenterology, P.A.

Orlando, Florida, 32835, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Henry Ford Health System

Novi, Michigan, 48377, United States

Location

Mayo Clinic - PPDS

Rochester, Minnesota, 55905, United States

Location

Delta Gastroenterology & Endoscopy Center

Southaven, Mississippi, 38671, United States

Location

Carolina Digestive Diseases

Greenville, North Carolina, 27834, United States

Location

Gastro Intestinal Research Institute of Northern Ohio

Westlake, Ohio, 44145, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

University of Utah - Health Sciences Center - PPDS

Salt Lake City, Utah, 84132, United States

Location

Cliagen Clinica de Atençao em Gastroenterologia, Especialidades e Nutriçao

Salvador, Estado de Bahia, 41500-300, Brazil

Location

L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

Brasília, Federal District, 70200-730, Brazil

Location

Hospital de Clinicas de Porto Alegre HCPA PPDS

Pôrto Alegre, Pará, 90035-903, Brazil

Location

Centro de Estudos Clinicos do Interior Paulista

Jaú, São Paulo, 17201-130, Brazil

Location

Pesquisare Saude

Santo André, São Paulo, 09080-110, Brazil

Location

Kaiser Hospital Dia

São José do Rio Preto, São Paulo, 15015-110, Brazil

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510080, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510655, China

Location

Jinhua municipal central hospital

Jinhua, 321000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

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

Ningbo, 315000, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430023, China

Location

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

SurGal Clinic s.r.o.

Brno, 602 00, Czechia

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 500 12, Czechia

Location

PreventaMed s.r.o.

Olomouc, 779 00, Czechia

Location

Endohope klinika s. r.o.

Prague, 150 00, Czechia

Location

Hôpital L'archet 2

Nice, Alpes-Maritimes, 06202, France

Location

CHU de Saint-Etienne - Hopital Nord

Saint-Etienne, 42055, France

Location

CHU de Nancy-Hopital Brabois Adulte

Vandœuvre-lès-Nancy, 54511, France

Location

Evangelismos General Hospital of Athens

Athens, Attica, 106 76, Greece

Location

Iatriko Palaiou Falirou

Palaió Fáliro, 175 62, Greece

Location

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

Bologna, Emilia-Romagna, 40138, Italy

Location

Fondazione Policlinico Universitario A Gemelli-Rome

Rome, Lazio, 00168, Italy

Location

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, 20132, Italy

Location

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

Centro Medico Clinico Quirurgico Especializado en Investigacion

Tlajomulco de Zúñiga, Jalisco, 45645, Mexico

Location

Medical Care & Research SA de CV

Mérida, Yucatán, 97070, Mexico

Location

EuroMediCare Szpital Specjalistyczny z Przychodni? we Wroc?awiu

Wroclaw, Lower Silesian Voivodeship, 54-144, Poland

Location

Centrum Medyczne Euromedis Sp. z o.o.

Sopot, Pomeranian Voivodeship, 81-756, Poland

Location

Clinical Trials UMED Sp. z o. o.

?ód?, 92-213, Poland

Location

Medical Center Kermed

Bydgoszcz, 85-231, Poland

Location

MZ Badania Slowik Zymla Sp.j.

Knurów, 44-190, Poland

Location

Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

Krakow, 31-506, Poland

Location

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

Nowy Targ, 34-400, Poland

Location

Office of Jaroslaw Kierkus, Dr n Med

Otwock, 05-400, Poland

Location

Sonomed Sp. z o.o.

Szczecin, 71-685, Poland

Location

Centrum Medyczne UNO-MED-Tarnow

Tarnów, 33-100, Poland

Location

NZOZ FORMED sp zo.o.

Wadowice, 34-100, Poland

Location

Centrum Zdrowia MDM

Warsaw, 00-635, Poland

Location

PlanetMed

Wroc?aw, 52-210, Poland

Location

Przychodnia VISTAMED

Wroc?aw, 53-149, Poland

Location

Clinical Hospital Center Zvezdara

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

General Hospital Djordje Joanovic - Zrenjanin

Zrenjanin, 23000, Serbia

Location

Inje university Haeundae Paik Hospital

Busan, 48108, South Korea

Location

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

Daejeon, 34943, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Gangwon-do, 26426, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trial

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: May 1, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (4); ME (2); CN (7); GR (2); SE (3); FR (3); KR (4); BR (6); CZ (4); TW (1); US (15); PL (14)