Study on the Effectiveness and Safety of RO7790121 for Patients with Moderate to Severe Crohn’s Disease

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What is this study about?

This clinical trial is focused on studying Crohn’s Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study will evaluate a treatment called RO7790121, which is being tested to see if it can help reduce the symptoms and inflammation associated with moderately to severely active Crohn’s Disease. The trial will compare the effects of RO7790121 with a placebo to determine its effectiveness and safety.

The purpose of the study is to assess whether RO7790121 can help patients achieve clinical remission, which means a significant reduction in disease activity, and an endoscopic response, which refers to visible improvements in the digestive tract as seen through an endoscope. Participants in the study will receive either the treatment or a placebo, and their progress will be monitored over time to see how well the treatment works in reducing symptoms and improving their condition.

Throughout the study, researchers will track various outcomes, such as the overall change in symptoms, the severity of symptoms, and the general well-being of participants. They will also monitor any adverse events, which are unwanted effects that might occur during the trial. The study aims to provide valuable information on the potential benefits and risks of using RO7790121 for treating Crohn’s Disease, helping to improve future treatment options for those affected by this condition.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This form confirms your understanding of the study and your willingness to participate.

If you are between 16 and 18 years old, you may also need to sign an assent form, depending on local guidelines.

2 initial assessment

An initial assessment will be conducted to confirm your diagnosis of moderately to severely active Crohn’s disease. This includes reviewing your medical history and conducting necessary tests.

Your body weight will be measured to ensure it is at least 40 kg, as this is a requirement for participation.

3 baseline evaluation

A baseline evaluation will be performed to assess the current state of your Crohn’s disease. This involves measuring the Crohn’s Disease Activity Index (CDAI) and the Simple Endoscopic Score for Crohn’s Disease (SES-CD).

The CDAI score should be between 220 and 450, and the SES-CD should be at least 6, or 4 for isolated ileal disease.

4 treatment phase

During the treatment phase, you will receive either the study medication RO7790121 or a placebo. This is a double-blind study, meaning neither you nor the study team will know which treatment you are receiving.

The medication will be administered according to the study protocol, which will be explained to you in detail by the study team.

5 regular monitoring

You will undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes clinical evaluations and endoscopic assessments.

Your symptoms and any side effects will be closely monitored throughout the study.

6 end of study evaluation

At the end of the study, a final evaluation will be conducted to determine the overall response to the treatment.

The primary goals are to achieve clinical remission and an endoscopic response, which will be measured by improvements in your CDAI and SES-CD scores.

Who Can Join the Study?

  • Sign a form to show you agree to participate. If you are younger, you might need to sign a special form called an Assent Form, depending on your age and local rules.
  • Be between the ages of 18 and 80 years old. If you are between 16 and 18 years old, you might still be able to join if local rules allow it.
  • Weigh at least 40 kg (about 88 pounds).
  • Have a confirmed diagnosis of Crohn’s Disease (CD), which means your doctor has used tests like looking inside your intestines with a camera (endoscopy) and examining tissue samples (histopathology) to confirm it.
  • Have moderately to severely active Crohn’s Disease. This means:
    • A score of 6 or more on a test called SES-CD, or 4 or more if the disease is only in the ileum (a part of the small intestine).
    • A score between 220 and 450 on a test called CDAI, which measures the severity of your symptoms.
  • The disease must affect the ileum (part of the small intestine) and/or the colon (large intestine). At least four parts of the colon should be reachable by a camera used in an endoscopy, or three parts if you have had surgery to remove part of your bowel.

Who Cannot Join the Study?

  • Patients with any other significant health condition that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
  • Patients who have had a major surgery within the last 12 weeks.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse within the last year.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain medications that could affect the study results.
  • Patients with a known allergy to any of the study medications.
  • Patients who have a history of certain heart conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Centre Hospitalier Departemental Vendee La Roche sur Yon France
University Hospital Ostrava Ostrava Czechia
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Ospedale San Raffaele S.r.l. Milan Italy
Semmelweis University Budapest Hungary
Centre Hospitalier Regional Universitaire De Tours Tours France
Centre Hospitalier Universitaire De Montpellier Montpellier France
CHRU De Nancy Vandoeuvre Les Nancy France
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Lille Lille France
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Ordensklinikum Linz GmbH Linz Austria
Institute For Clinical And Experimental Medicine Prague Czechia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Vrije Universiteit Brussel Jette Belgium
Universita Degli Studi Di Brescia Brescia Italy
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Vas-Oxy Kft. Szombathely Hungary
KBC Zagreb Zagreb Croatia
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Centre Hospitalier Et Universitaire De Limoges Limoges France
Assistance Publique Hopitaux De Paris Paris France
IRCCS Policlinico San Donato San Donato Milanese Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
CHU Saint Pierre Brussels Belgium
Krajska zdravotni a.s. Teplice Czechia
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Planetmed Sp. z o.o. Wroclaw Poland
EMC Instytut Medyczny S.A. Poznan Poland

Other Sites

Site Name City Country Status
Klinikum Wels-Grieskirchen GmbH Wels Austria
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD Plovdiv Bulgaria
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Warsaw Poland
Geomedical Kft. Budapest Hungary
Medrise Sp. z o.o. Lublin Poland
Gqwydoowd Kmuwskd Rjbadfdbvm Smeefbfqzs Sse jt Bialystok Poland
Akdebet Sxwhdqqjl Lougyo Mxfwdj Matera Italy
Osmazzf Bkcqc Kvqmgdgiusk Bk Rahdqxiv Svs z ogkh Ilawa Poland
Mvdvqpa Cppxxk Fyvuistqeu Erjo Plovdiv Bulgaria
Mjecg Cfqkejon Riuskvqa Sia z ozkv Warsaw Poland
Atydlof Sfa z owvi Susn Lodz Poland
Euuhsflzs Krjk Budapest Hungary
Hlpspjnueznonagvpaxyiwwd Ho smiiwl Hradec Kralove Czechia
Kb Mufblcphyh smora s rshe Nitra Slovakia
Iuupjz amlb Prague Czechia
Kntpnsti Emguk vvl Btiufgvj gbouc Potsdam Germany
Pmfogk Pdcghb Rpihndbldk Shq jf Cracow Poland
Ctcbdtu Mrtytrnz Kykueg Rkjgwl Bkffdjrccxopma I Eyq Khklaaugiw Sim jb Bydgoszcz Poland
Smvvwcn Seq z oodt Szczecin Poland
En Gqlbb Snq z onpp Warsaw Poland
Npgo Zczaoqjwdf Kywnzzlxs I Wzdbpfqvv Scr jb Staszow Poland
Cagelib Mksrpghm Ociehh Wroclaw Poland
Siopopd Mqobskl See Jscx Ptvti Ia W Eilrpnv Elblag Poland
Cwojpjox Rejiyuso Czolrk Sxy z offy Mackjdz smhfi Poznan Poland
Md Bncwpzc Sachbi Zmxki Srh ji Knurow Poland
Ueajhok Lhucc Dy Suaje Dh Edqky O Dkssu E Vqrqd Erctdv Santa Maria Da Feira Portugal
Mttcwyofkuuv Hupruwge Fuk Azrcwg Tyxsidnvgzhwd Hqlxqcht Lehq Panagyurishte Bulgaria
Eflwuukgpb Sow z olgf Sopot Poland
Pvmwkmnxwvx Bpswym dfload Osijek Croatia
Rfnkjciu Shk z outb Poznan Poland
Fzbavkcq Nhtluyapq S Pwqolaoafwre Nuzu Zziwg Nove Zamky Slovakia
Amczr sckon s riss Vrakuna Slovakia
Tgm Mbu Slbt Subevd Cluj Napoca Romania
Csqffabg Hdsehzks Digpfuw Zagreb Croatia
Pmzuc Wjbcpxa Guvageo Emyjdvqbyd Pbvdsktw Pafbdpeuqog Cracow Poland
Gqouyrwtnwpcoybhmgzd Sgazqhyullvnncgrpfdniezksddxekj Berlin Germany

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.03.2025
Belgium Belgium
Recruiting
01.03.2025
Bulgaria Bulgaria
Recruiting
01.03.2025
Croatia Croatia
Recruiting
01.03.2025
Czechia Czechia
Recruiting
01.03.2025
France France
Recruiting
01.03.2025
Germany Germany
Recruiting
01.03.2025
Hungary Hungary
Recruiting
01.03.2025
Italy Italy
Recruiting
01.03.2025
Poland Poland
Recruiting
01.03.2025
Portugal Portugal
Recruiting
01.03.2025
Romania Romania
Not yet recruiting
01.03.2025
Slovakia Slovakia
Recruiting
01.03.2025
Spain Spain
Recruiting
01.03.2025

Trial locations

Investigated Drugs:

RO7790121 is a medication being tested in this clinical trial for its ability to help people with Crohn’s Disease, which is a condition that causes inflammation in the digestive tract. This medication is being studied to see if it can help reduce the symptoms of Crohn’s Disease and improve the health of the digestive system. The trial aims to find out if this medication can help patients achieve clinical remission, which means that the symptoms of the disease are reduced or disappear, and also to see if it can improve the appearance of the digestive tract when viewed with a special camera. The goal is to determine if this medication can be a safe and effective treatment option for people with moderately to severely active Crohn’s Disease.

Investigated Diseases:

Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active disease, known as flares, and periods of remission. During active phases, symptoms may include abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can progress unpredictably, with varying severity and frequency of symptoms. Over time, the inflammation can cause damage to the digestive tract, potentially leading to further complications.

Trial ID:
2024-513054-30-00
Protocol code:
GA45332
Trial Phase:
Therapeutic confirmatory (Phase III)

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