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Study of RVT-3101 for Treating Moderate to Severe Crohn’s Disease in Patients

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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 treatment being tested in this study is a medication known as RO7790121, which is administered as a solution for injection under the skin. The purpose of the study is to evaluate the safety and tolerability of this medication in individuals with moderate to severe active Crohn’s disease.

Participants in the study will receive either the medication RO7790121 or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, with regular check-ups to monitor the participants’ health and any side effects they may experience. The goal is to see how well the medication works in reducing the symptoms of Crohn’s disease and to gather information on any potential side effects.

Throughout the study, participants will be closely monitored for any adverse effects, and their progress will be assessed using various measures, such as endoscopic examinations and clinical evaluations. The study aims to provide valuable information on the effectiveness and safety of RO7790121 as a potential treatment for Crohn’s disease, which could lead to improved management of this challenging condition in the future.

1 initial visit

Upon joining the study, the initial visit involves a comprehensive assessment to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure a confirmed diagnosis of Crohn’s disease.

The Crohn’s Disease Activity Index (CDAI) score is determined to assess the severity of the condition. This score must be between 220 and 450.

2 baseline visit

The baseline visit marks the official start of the trial. During this visit, the first dose of the study medication, RO7790121, is administered as a solution for injection.

Participants receive instructions on how to monitor and report any side effects or changes in their condition.

3 treatment phase

Throughout the treatment phase, RO7790121 is administered subcutaneously. The frequency and dosage are determined by the study protocol and are closely monitored by the research team.

Participants are required to attend regular follow-up visits to assess the medication’s effects and to ensure safety and tolerability.

4 mid-study assessment

At week 14, a mid-study assessment is conducted to evaluate the response to the treatment. This includes an endoscopic examination to measure any decrease in the Simple Endoscopic Score for Crohn’s Disease (SES-CD).

Clinical remission is assessed by checking if the CDAI score is below 150.

5 end of treatment phase

The treatment phase concludes with a final assessment to evaluate the overall effectiveness and safety of RO7790121.

Participants are monitored for any adverse events, and the study team collects data on the proportion of participants achieving clinical remission.

6 follow-up period

After the treatment phase, a follow-up period is conducted to monitor long-term effects and any delayed side effects of the medication.

Participants may be required to attend additional visits or provide information on their health status.

Who Can Join the Study?

  • Participants must provide a signed and dated written consent form before any study-related activities begin. This means they agree to take part in the study after being informed about it.
  • Participants can be of any gender and must be between 18 and 75 years old. If local rules allow, participants can be younger than 18 if they are at the age of consent.
  • Participants must have a confirmed diagnosis of Crohn’s disease affecting the ileum, ileocolon, or colon for at least 12 weeks (about 3 months) before the first visit of the study. This diagnosis should be supported by a biopsy, which is a small sample of tissue taken for testing.
  • Participants need to have a CDAI score between 220 and 450 at the screening. CDAI stands for Crohn’s Disease Activity Index, which is a way to measure the severity of Crohn’s disease. This score should be determined before a screening colonoscopy, which is a procedure to look inside the colon.

Who Cannot Join the Study?

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer within the last five years, except for certain types of skin cancer.
  • Patients who have a history of heart problems, such as heart attack or heart failure.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD Sliven Bulgaria
IRCCS Humanitas Research Hospital Rozzano Italy
DRK Kliniken Berlin Berlin Germany
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Ospedale San Raffaele S.r.l. Milan Italy
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
ASST Fatebenefratelli Sacco Milan Italy
Centre hospitalier universitaire de Liege Liege Belgium
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
National Institute Of Gastroenterology Saverio De Bellis Research Hospital Castellana Grotte Italy
Semmelweis University Budapest Hungary
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Clinexpert Kft. Budapest Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universita’ Campus Bio-medico Di Roma Rome Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
ARNAS G. Brotzu Cagliari Italy
KM Management spol. s r.o. Nitra Slovakia
PreventaMed s.r.o. Olomouc Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Heidelberg University Mannheim Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Zentrum fuer Gastroenterologie Saar MVZ GmbH Saarbrücken Germany
Abawi spol. s r.o. Vrakuna Slovakia
Fundación para la investigación biomédica de Córdoba Cordoba Spain
University Hospital Ostrava Ostrava Czechia
Semmelweis University Budapest Hungary
Cfvf Ds Ngbkf Vandoeuvre Les Nancy France
Nhuawbpwl Htnchqph Horovice Czechia
Elhasjv shdfwt Kosice Slovakia
Ssv Ebaydstks Hqolkxxo Tqpntze Tilburg The Netherlands
Avonbjgnx Uab Amsterdam The Netherlands
Hzxxtarv Ugftukgcoguir Mwgvcel Dp Vfzcotoqmz Santander Spain
Uvopqnbtvr Mmqmp Gzinqba Ob Cnmikqnqj Catanzaro Italy
Fmgmmjwfp Plmn Lg Iqgpnpqwdszkg Bbrjxduwi Dve Hygxofuz Ujejcrmxidlap Ld Pvd Madrid Spain
Koehbpk zttbareuj ahtt &bosubi Melxoszihw nhtxjwzzj Úify nnk Lxjxki osps Usti Nad Labem Czechia
Win Wwpkdz Ihp Pxevx Pivecszu Kijmoyl Warsaw Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
ended
11.09.2023
Bulgaria Bulgaria
Not recruiting
11.09.2023
Czechia Czechia
Not recruiting
11.09.2023
France France
Not recruiting
11.09.2023
Germany Germany
Not recruiting
11.09.2023
Hungary Hungary
Not recruiting
11.09.2023
Italy Italy
Not recruiting
11.09.2023
Poland Poland
Not recruiting
11.09.2023
Slovakia Slovakia
Not recruiting
11.09.2023
Spain Spain
Not recruiting
11.09.2023
The Netherlands The Netherlands
Not recruiting
11.09.2023

Trial locations

Investigated drugs:

RO7790121 is an investigational medication being studied for its potential to treat moderate to severe active Crohn’s disease. It is administered through an injection under the skin. The main goal of the study is to assess how safe and well-tolerated this medication is for patients with this condition.

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 flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience 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 exact cause of Crohn’s disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The progression of the disease is unpredictable, with some people experiencing long periods of remission and others having frequent flare-ups.

Trial ID:
2023-504265-23-00
Protocol code:
GA45392/RVT-3101-201
NCT ID:
NCT05910528
Trial Phase:
Therapeutic exploratory (Phase II)

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