Study of RO7837195 injection compared to placebo to treat moderate to severe ulcerative colitis

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What is this study about?

This clinical trial focuses on patients with Ulcerative Colitis, a chronic inflammatory condition affecting the large intestine. The study specifically targets individuals with moderately to severely active disease. The investigational medication being tested is RO7837195, which is a recombinant bispecific antibody given as a solution for injection under the skin (subcutaneous use).

The purpose of this study is to determine if RO7837195 is effective in inducing remission in people with moderately to severely active Ulcerative Colitis when compared to placebo. The study is designed as a double-blind trial, meaning neither the participants nor the doctors know who receives which treatment during the study. The medication will be tested over a 12-week period, followed by an additional treatment phase.

During the study, participants will receive either RO7837195 or placebo through injections under the skin. The study will monitor various aspects of the disease activity, including symptoms such as stool frequency and bleeding. The researchers will also track how the body processes the medication and check for any potential side effects throughout the study period.

1 Initial screening

Your ulcerative colitis (UC) diagnosis must be confirmed by clinical and endoscopic examination

A colonoscopy or flexible sigmoidoscopy will be performed to verify that your UC extends at least 15 cm from the anal area

Your disease activity will be assessed using a modified Mayo Score to confirm moderate to severe UC

2 Treatment phase – first 12 weeks

You will receive either RO7837195 or a placebo through subcutaneous injection (injection under the skin)

Regular assessments will monitor your response to treatment

Your stool frequency and any rectal bleeding will be tracked

Blood tests will be conducted to measure drug levels in your body

Your vital signs and laboratory test results will be monitored throughout the study

3 Week 12 evaluation

An endoscopic examination will be performed to assess your response to treatment

Your disease activity will be measured using the modified Mayo Score

The effectiveness of the treatment will be evaluated based on improvements in your symptoms

Blood tests will check for the presence of antibodies to the study medication

4 Active treatment extension

Following the initial 12-week period, you may continue in an extended treatment phase

Regular monitoring of your condition will continue

Safety assessments and blood tests will be performed periodically

The study will continue until approximately June 2028

Who Can Join the Study?

  • Must be diagnosed with Ulcerative Colitis (UC) for at least 3 months before screening, confirmed by clinical examination and internal viewing of the colon during screening
  • The inflammation in your colon must extend at least 15 centimeters from the anus, as shown by examination with a flexible tube with a camera (endoscopy) during screening
  • Must have had a complete colon examination (colonoscopy) within the past 2 years, or be willing to have one during screening instead of a partial examination
  • Must have moderate to severe active UC, as measured by a special scoring system called the modified Mayo Score of 5-9, including signs of inflammation seen during the internal examination
  • Must agree to follow the study’s requirements for birth control and pregnancy prevention
  • Must have previously tried and not responded adequately to standard UC treatments or advanced therapies
  • Must be an adult (18 years or older)
  • Can be either male or female

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Current or recent participation in other clinical trials (within last 30 days)
  • Major surgery within the past 3 months
  • Active or chronic infections, including tuberculosis or hepatitis (liver inflammation)
  • History of cancer in the past 5 years (except successfully treated skin cancer)
  • Severe heart, liver, or kidney disease
  • Current substance abuse or alcohol dependence
  • Mental health conditions that could interfere with study participation
  • Use of prohibited medications, including immunosuppressants (medications that weaken the immune system)
  • History of gastrointestinal perforation (hole in the digestive tract)
  • Severe, uncontrolled inflammatory bowel disease (severe gut inflammation)
  • Blood disorders or significant abnormal blood test results
  • Unable to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Wsd Medi Clinical Sp. z o.o. Warsaw Poland
Medon Clinical Research Sp. z o.o. Warsaw Poland
PreventaMed s.r.o. Olomouc Czechia
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Eb Group Sp. z o.o. Warsaw Poland
Centrum Medyczne Oporow Wroclaw Poland
Vita Longa Sp. z o.o. Katowice Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Fondazione Poliambulanza Brescia Italy
Termedia Sp. z o.o. Poznan Poland
Centrum Medyczne Clw-Med Aneta Cichomska I Joanna Luka-Wendrowska Sp. j. Grudziadz Poland
Mz Badania Slowik Zymla Sp. j. Knurow Poland
Azienda Ospedaliera di Padova Padua Italy
Nemocnice Slany Slany Czechia
Clinmedica Research sp. z o.o. Skierniewice Poland
Universitaetsklinikum Regensburg AöR Regensburg Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
IRCCS Policlinico San Donato San Donato Milanese Italy
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Centre Hospitalier Lyon Sud Pierre Benite France
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Clinoxus s.r.o. Prague Czechia
Vaetoloa &gayb Vpihksp Scw z odsh Wroclaw Poland
Sxybupw Cpeudsl Mrssufjc Srp z odrg Poznan Poland
Ptbsvyr Pnyohwtaoga Skc z oslu Warsaw Poland
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Okfrqir Bmgql Kahwxmxityx Cfxmdxdrc Srgd Eph Ghzavxavchpfx Mwyxbhntwv Tahxkdp Bydgoszcz Poland
Pakglizhkds Eelssuhanueh Wroclaw Poland
Mapumfbi Sh z oycu Bydgoszcz Poland
Eta Zljjnj Zamosc Poland
Pmyrcorwe Ivonolta Mynydtrc Mawjpmibwyqj Sbnrk Wxszldglbtmb I Adanrulgmeotd Warsaw Poland
Gyzfny Uphosyogwg Fngfegmsi Frankfurt Germany
Inbpybqp di Caytwdkxmxhd Hjiozjnqxox Umamgszleuqni dt Sxbch Ehtnlbg (khviezu Saint Priest En Jarez France
Wdl Wrydos Idz Ppysw Psrxarul Kgnkgyr Warsaw Poland
Apohpha Sundr Sigdauzkr Tzsdkwwahhvi Rcunxivz Rho Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
22.10.2025
France France
Recruiting
22.10.2025
Germany Germany
Recruiting
22.10.2025
Italy Italy
Recruiting
22.10.2025
Poland Poland
Recruiting
22.10.2025

Trial locations

Investigated drugs:

RO7837195 is an investigational medication being studied for treating ulcerative colitis, which is a condition that causes inflammation in the large intestine. The medication is being tested to see if it can help reduce inflammation and symptoms in patients with moderate to severe forms of the disease. This is a new drug that is still known by its development code name since it hasn’t yet been given an official generic or brand name.

Ulcerative Colitis – A chronic inflammatory bowel disease that causes inflammation and ulcers in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The condition typically develops over time, with symptoms that can include diarrhea, abdominal pain, and rectal bleeding. The inflammation usually begins in the rectum and lower colon but may spread continuously to involve other parts of the colon. Patients experience periods of active disease (flares) alternating with periods of remission. The disease can cause changes in bowel habits and frequent urgency to empty the bowels.

Trial ID:
2025-520690-39-00
Protocol code:
GA45977
Trial Phase:
Therapeutic exploratory (Phase II)

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