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Ulcerative ColitisPhase 2NCT06137183

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

A Phase 2 study testing Vixarelimab in people with Ulcerative Colitis, run by Genentech, Inc. at 65 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Vixarelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
79 participants
Where
65 sitesin 12 countries
Study dates
1 May 2024to 16 Jun 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

65 sites in 12 countries.

65 sites in 12 countries

United States15 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • OM Research LLC - Camarillo - ClinEdge - PPDS

    Camarillo, California, 93012

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • UCLA Clinical and Translational Research Center

    Los Angeles, California, 90095

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Facey Medical Foundation - Mission Hills

    Mission Hills, California, 91345 1116

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • Henry Ford Health System

    Novi, Michigan, 48377

  • Orlando Gastroenterology, P.A.

    Orlando, Florida, 32835

  • Mayo Clinic - PPDS

    Rochester, Minnesota, 55905

  • University of Utah - Health Sciences Center - PPDS

    Salt Lake City, Utah, 84132

  • Clinical Applications Laboratories, Inc.

    San Diego, California, 92103-5639

  • Delta Gastroenterology & Endoscopy Center

    Southaven, Mississippi, 38671

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Gastro Intestinal Research Institute of Northern Ohio

    Westlake, Ohio, 44145

Other trials in United States

Poland14 sites

  • Clinical Trials UMED Sp. z o. o.

    ?ód?, 92-213

  • Medical Center Kermed

    Bydgoszcz, 85-231

  • MZ Badania Slowik Zymla Sp.j.

    Knurów, 44-190

  • Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

    Krakow, 31-506

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

    Nowy Targ, 34-400

  • Office of Jaroslaw Kierkus, Dr n Med

    Otwock, 05-400

  • Centrum Medyczne Euromedis Sp. z o.o.

    Sopot, Pomeranian Voivodeship, 81-756

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

  • Centrum Medyczne UNO-MED-Tarnow

    Tarnów, 33-100

  • NZOZ FORMED sp zo.o.

    Wadowice, 34-100

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • PlanetMed

    Wroc?aw, 52-210

  • Przychodnia VISTAMED

    Wroc?aw, 53-149

  • EuroMediCare Szpital Specjalistyczny z Przychodni? we Wroc?awiu

    Wroclaw, Lower Silesian Voivodeship, 54-144

Other trials in Poland

China7 sites

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510655

  • Jinhua municipal central hospital

    Jinhua, 321000

  • The First Affiliated Hospital of Nanchang University

    Nanchang

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

    Ningbo, 315000

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

    Wuhan, 430023

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

Other trials in China

Brazil6 sites

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    Brasília, Federal District, 70200-730

  • Centro de Estudos Clinicos do Interior Paulista

    Jaú, São Paulo, 17201-130

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará, 90035-903

  • Cliagen Clinica de Atençao em Gastroenterologia, Especialidades e Nutriçao

    Salvador, Estado de Bahia, 41500-300

  • Pesquisare Saude

    Santo André, São Paulo, 09080-110

  • Kaiser Hospital Dia

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

Other trials in Brazil

Czechia4 sites

  • SurGal Clinic s.r.o.

    Brno, 602 00

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

    Hradec Králové, 500 12

  • PreventaMed s.r.o.

    Olomouc, 779 00

  • Endohope klinika s. r.o.

    Prague, 150 00

Other trials in Czechia

Italy4 sites

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

    Bologna, Emilia-Romagna, 40138

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

    Milan, Lombardy, 20132

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

Other trials in Italy

South Korea4 sites

  • Inje university Haeundae Paik Hospital

    Busan, 48108

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

    Daejeon, 34943

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-do, 26426

  • Kangbuk Samsung Hospital

    Seoul, 03181

Other trials in South Korea

France3 sites

  • Hôpital L'archet 2

    Nice, Alpes-Maritimes, 06202

  • CHU de Saint-Etienne - Hopital Nord

    Saint-Etienne, 42055

  • CHU de Nancy-Hopital Brabois Adulte

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Serbia3 sites

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • General Hospital Djordje Joanovic - Zrenjanin

    Zrenjanin, 23000

Other trials in Serbia

Greece2 sites

  • Evangelismos General Hospital of Athens

    Athens, Attica, 106 76

  • Iatriko Palaiou Falirou

    Palaió Fáliro, 175 62

Other trials in Greece

Mexico2 sites

  • Medical Care & Research SA de CV

    Mérida, Yucatán, 97070

  • Centro Medico Clinico Quirurgico Especializado en Investigacion

    Tlajomulco de Zúñiga, Jalisco, 45645

Other trials in Mexico

Taiwan1 site

  • China Medical University Hospital

    Taichung, 40447

Other trials in Taiwan

About this study

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

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.

Read the 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.
Being tested
Vixarelimab, Placebo
Keywords
Inflammatory Bowel Disease, Gastrointestinal Disease, Ulcerative Colitis, Colitis
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases, Gastrointestinal Diseases, Colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VixarelimabDrug

    Also called RO7622888; KPL-716

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

  • PlaceboDrug

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

Study groups in NCT06137183
Study groupRoleWhat they receive
Vixarelimab Dose Regimen 1ExperimentalParticipants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.
Receives: Drug: Vixarelimab
Vixarelimab Dose Regimen 2ExperimentalParticipants will receive vixarelimab SC during the induction period and the optional ATE period.
Receives: Drug: Vixarelimab
PlaceboPlacebo comparatorParticipants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.
Receives: Drug: Vixarelimab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Week 12

Secondary outcomes (6)

  1. 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.

    Measured: At Week 12

  2. 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.

    Measured: At Week 12

  3. 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.

    Measured: At Week 12

  4. 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.

    Measured: 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)

  5. Serum Concentration of Vixarelimab at Specified Timepoints

    Measured: Weeks 0, 1, 2, 4, 8, 12, and study completion/early termination (up to 22 weeks)

  6. 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.

    Measured: Baseline and post-baseline visits (up to 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 May 2024
  3. Primary completion16 Jun 2025
  4. Study completion16 Jun 2025

Why it stopped: Based on a futility analysis, which suggested that the Moonglow study was unlikely to meet its primary endpoint.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06137183
Sponsor's protocol ID
GA44839
Other IDs
2023-506655-19-00, 2023
Status last verified
Feb 2026
First submitted
13 Nov 2023
Last updated
24 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vixarelimab in people with Ulcerative Colitis, run by Genentech, Inc. at 65 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Poland, China, Brazil, Czechia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Clinical Remission at Week 12 (time frame: At Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06137183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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