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Ulcerative ColitisPhase 2NCT06979336

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

A Phase 2 study testing RO7837195 in people with Ulcerative Colitis, run by Genentech, Inc. at 111 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed. 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?
RO7837195
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
224 participants
Where
111 sitesin 15 countries
Study dates
29 Sep 2025to 31 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 ulcerative colitis (UC) established at least 3 months
  • Moderately to severely active UC assessed by mMS
  • Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC

Who cannot join

  • Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
  • Diagnosis of Crohn's disease or indeterminate colitis
  • Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
  • Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23

Trial locations and contacts

111 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S.)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

111 sites in 15 countries

Poland18 sites, 14 recruiting

  • Centrum Medyczne "Medis"

    Bydgoszcz, 85-229

    Recruiting

  • Clinsante S.C. Osrodek Badan Klinicznych

    Bydgoszcz, 85-794

    Recruiting

  • Centrum Medyczne Lukamed Joanna Luka

    Chojnice, 89-600

    Recruiting

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

    Recruiting

  • MZ Badania Slowik Zymla Sp.j.

    Knurów, 44-190

    Recruiting

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

    Nowy Targ, 34-400

    Recruiting

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

    Recruiting

  • NSZOZ Termedica Centrum Badan Klinicznych

    Poznan, 60-681

    Recruiting

  • Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k.

    Poznan, 61-731

    Recruiting

  • Velocity Skierniewice Sp. z o.o

    Skierniewice, 96-100

    Withdrawn

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434

    Recruiting

  • Centrum Zdrowia MDM

    Warsaw, 00-189

    Withdrawn

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji

    Warsaw, 02-507

    Withdrawn

  • Provita Poliklinika sp. z o.o

    Warsaw, 02-647

    Withdrawn

  • Medon Clinical Research sp. z o.o

    Warsaw, 02-679

    Recruiting

  • Medical Network Spka z o. o., WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501

    Recruiting

  • Przychodnia VISTAMED

    Wroc?aw, 53-149

    Recruiting

  • ETG Zamosc

    Zamość, 22-400

    Recruiting

Other trials in Poland

Brazil16 sites, 16 recruiting

  • Newdata Clinical Trials

    Aracaju, Sergipe, 49075-000

    Recruiting

  • Hospital Felicio Rocho

    Belo Horizonte, Minas Gerais, 30110-934

    Recruiting

  • L2IP ?Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

    Recruiting

  • Chronos Pesquisa Clinica

    Brasília, Federal District, 72145-450

    Recruiting

  • Associao Paranaense de Cultura APC

    Curitiba, Paraná, 80230-130

    Recruiting

  • Centro Digestivo de Curitiba

    Curitiba, Paraná, 80430-160

    Recruiting

  • HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear

    Fortaleza, Ceará, 60430-370

    Recruiting

  • CECIP - Centro de Estudos Clínicos do Interior Paulista

    Ja, São Paulo, 17201-130

    Recruiting

  • Hospital de Clnicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

    Recruiting

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul, 90160-093

    Recruiting

  • Hospital Gloria DOr - Hospitais Integrados da Gavea S/A

    Rio de Janeiro, 22211-230

    Recruiting

  • Pesquisare Saude

    Santo André, São Paulo, 09080-110

    Recruiting

  • Kaiser Clinica

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

    Recruiting

  • Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

    São Paulo, São Paulo, 04039-004

    Recruiting

  • BR Trials - Ensaios Clnicos e Consultoria

    São Paulo, São Paulo, 05003-090

    Recruiting

  • CPQuali Pesquisa Clinica Ltda

    So Paulo, São Paulo, 01228-000

    Recruiting

Other trials in Brazil

China12 sites, 12 recruiting

  • Binzhou Medical university hospital

    Binzhou, Shandong, 256603

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, Fujian, 350005

    Recruiting

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

    Recruiting

  • The sixth affiliated hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510655

    Recruiting

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310018

    Recruiting

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong, 516001

    Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

    Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

    Recruiting

Other trials in China

United States9 sites, 9 recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

    Recruiting

  • Intercity Gastroenterology

    Fresh Meadows, New York, 11366

    Recruiting

  • Clinical Research of Osceola, LLC

    Kissimmee, Florida, 34741

    Recruiting

  • Gastro Care Institute

    Lancaster, California, 93534

    Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

    Recruiting

  • University of Rochester - PARENT

    Rochester, New York, 14642

    Recruiting

  • University of Utah Hospitals & Clinics

    Salt Lake City, Utah, 84132

    Recruiting

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

    Recruiting

Other trials in United States

Italy9 sites, 9 recruiting

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, Lombardy, 25124

    Recruiting

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

    Recruiting

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto, 37024

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100

    Recruiting

  • ASST Rhodense, Rho Memorial Hospital

    Rho, Lombardy, 20017

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Emilia-Romagna, 00168

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

    Recruiting

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese (MI), Lombardy, 20097

    Recruiting

  • Ospedale Mauriziano Umberto I

    Turin, Piedmont, 10128

    Recruiting

Other trials in Italy

Japan9 sites, 9 recruiting

  • Shinseikai Sai Gastroenterology, Proctology

    Fujidera-shi, 583-0027

    Recruiting

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

    Recruiting

  • NHO Fukuyama Medical Center

    Fukuyama-shi, Hiroshima, 720-8520

    Recruiting

  • NHO Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 920-8650

    Recruiting

  • Kokikai Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba, 277-0871

    Recruiting

  • Kojunkai Daido Clinic

    Nagoya, 457-8511

    Recruiting

  • NHO Osaka National Hospital

    Osaka, Osaka, 540-0006

    Recruiting

  • Saga University Hospital

    Saga, Saga-ken, 849-8501

    Recruiting

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017

    Recruiting

Other trials in Japan

South Korea9 sites, 9 recruiting

  • Inje university Haeundae Paik Hospital

    Busan, 48108

    Recruiting

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

    Daejeon, 34943

    Recruiting

  • Chosun University Hospital

    Gwangju, 61453

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181

    Recruiting

  • The Catholic University of Korea Eunpyeong St. Mary's Hospital

    Seoul, 03312

    Recruiting

  • Asan Medical Center.

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Chung-Ang University Hospital

    Seoul, 06973

    Recruiting

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

    Recruiting

Other trials in South Korea

India5 sites, 5 recruiting

  • Asian Institute of Gastroenterology

    Hyderabad, Andhra Pradesh, 500032

    Recruiting

  • S. R. Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001J

    Recruiting

  • Institute of Post Graduate Medical Education And Research

    Kolkata, West Bengal, 700020

    Recruiting

  • Kingsway Hospital

    Nagpur, Maharashtra, 440010

    Recruiting

  • Shree Giriraj Multispeciality Hospital

    Rajkot, Gujarat, 360005

    Recruiting

Other trials in India

Mexico5 sites, 5 recruiting

  • Clinica de Investigacion en Reumatologia y Obesidad S.C.

    Guadalajara, Jalisco, 44650

    Recruiting

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

    Mérida, Yucatán, 97130

    Recruiting

  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

    San Luis Potosí City, 78213

    Recruiting

  • Centro Medico Clinico Quirurgico Especializado en Investigacion

    Tlajomulco de Zúñiga, Jalisco, 45645

    Recruiting

  • FAICIC S de R.L. de C.V

    Veracruz, 91900

    Recruiting

Other trials in Mexico

United Kingdom5 sites, 5 recruiting

  • Addenbrook'es Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Royal Liverpool University Hospital

    Liverpool, Merseyside, L7 8YE

    Recruiting

  • Guy's Hospital

    London, Greater London, SE1 9RT

    Recruiting

  • King's College Hospital

    London, Greater London, SE5 9RS

    Recruiting

  • John Radcliffe Hospital

    Oxford, Oxfordshire, OX3 9DU

    Recruiting

Other trials in United Kingdom

Australia4 sites, 4 recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

    Recruiting

  • Royal Melbourne Hospital

    Parkville VIC, Victoria, 3050

    Recruiting

  • Mater Misericordiae Limited

    South Brisbane, Queensland, 4101

    Recruiting

Other trials in Australia

France4 sites, 4 recruiting

  • CHU Clermont Ferrand - Hôpital d'Estaing

    Clermont-Ferrand, Puy De Dome, 63000

    Recruiting

  • Groupe Hospitalier Ambroise Pare - Institut des MICI

    Neuilly, Hauts De Seine, 92200

    Recruiting

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, Rhone, 69495

    Recruiting

  • CHU Saint Etienne - Hpital Nord

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055

    Recruiting

Other trials in France

Canada3 sites, 3 recruiting

  • London Digestive Disease Institute

    London, Ontario, N6K 1M6

    Recruiting

  • Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral

    Montreal, Quebec, H1T 2M4

    Recruiting

  • Clinique IMD

    Montreal, Quebec, H3H 1E8

    Recruiting

Other trials in Canada

Czechia2 sites, 1 recruiting

  • PreventaMed, s.r.o.

    Olomouc, 779 00

    Recruiting

  • Nemocnice Slany

    Slaný, 27401

    Withdrawn

Other trials in Czechia

Germany1 site, 1 recruiting

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt am Main, Hesse, 60590

    Recruiting

Other trials in Germany

About this study

Official title: A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

Read the detailed description

This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.

Being tested
RO7837195, RO7837195 Matched Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • RO7837195Drug

    RO7837195 will be administered as per the schedule specified in the protocol.

  • RO7837195 Matched PlaceboDrug

    RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

Study groups in NCT06979336
Study groupRoleWhat they receive
RO7837195 Dose Regimen 1ExperimentalParticipants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Receives: Drug: RO7837195
RO7837195 Dose Regimen 2ExperimentalParticipants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Receives: Drug: RO7837195
RO7837195 Dose Regimen 3ExperimentalParticipants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Receives: Drug: RO7837195
RO7837195 Dose Regimen 4ExperimentalParticipants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Receives: Drug: RO7837195
RO7837195 Matched Placebo/ RO7837195ExperimentalParticipants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively.
Receives: Drug: RO7837195; Drug: RO7837195 Matched 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 is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1.

    Measured: At Week 12

Secondary outcomes (6)

  1. Percentage of Participants With Clinical Response at Week 12

    Clinical response is defined as decrease from baseline in the mMS by ≥2 and ≥ 30% reduction from baseline, with either a decrease of ≥1 in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤1.

    Measured: At Week 12

  2. Percentage of Participants With Endoscopic Improvement at Week 12

    Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1.

    Measured: At Week 12

  3. Percentage of Participants With Endoscopic Remission at Week 12

    Endoscopic remission is defined as a Mayo endoscopy subscore of 0.

    Measured: At Week 12

  4. Number of Participants With Adverse Events (AEs)

    Measured: Up to Weeks 65

  5. Serum Concentration of RO7837195

    Measured: Up to Weeks 65

  6. Percentage of Participants With Anti-drug Antibodies to RO7837195

    Measured: Up to Weeks 65

Timeline

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

  1. First posted18 May 2025
  2. Study start29 Sep 2025
  3. Primary completion25 Aug 2027 (estimated)
  4. Study completion31 Oct 2028 (estimated)

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
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06979336
Sponsor's protocol ID
GA45977
Other IDs
2025-520690-39-00, 2025
Status last verified
Oct 2026
First submitted
15 May 2025
Last updated
27 Oct 2026
Results posted
No
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 RO7837195 in people with Ulcerative Colitis, run by Genentech, Inc. at 111 sites in 15 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in Poland, Brazil, China, United States, Italy and 10 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. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S.), global-roche-genentech-trials@gene.com), or a site near the patient. 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 NCT06979336.

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 27 Oct 2026.

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