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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD	Plovdiv	Bulgaria
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz	Warsaw	Poland
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Geomedical Kft.	Budapest	Hungary

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
KBC Zagreb	Zagreb	Croatia
Medon Clinical Research Sp. z o.o.	Warsaw	Poland
Amicare Sp. z o.o. S.K.	Lodz	Poland
Iscare a.s.	Prague	Czechia
Klinikum Ernst von Bergmann gGmbH	Potsdam	Germany
CHU Saint Pierre	Brussels	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Promed P.Lach R.Glowacki Sp. j.	Cracow	Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
Sonomed Sp. z o.o.	Szczecin	Poland
Eb Group Sp. z o.o.	Warsaw	Poland
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.	Staszow	Poland
Centrum Medyczne Oporow	Wroclaw	Poland
Hospital Universitario De Fuenlabrada	Fuenlabrada	Spain
Szpital Miejski Sw. Jana Pawla II W Elblagu	Elblag	Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.	Santa Maria Da Feira	Portugal
Endoskopia Sp. z o.o.	Sopot	Poland
Planetmed Sp. z o.o.	Wroclaw	Poland
Poliklinika Borzan d.o.o.	Osijek	Croatia
Rivermed Sp. z o.o.	Poznan	Poland
Tvm Med Serv S.R.L.	Cluj Napoca	Romania
Mz Badania Slowik Zymla Sp. j.	Knurow	Poland
Fakultna Nemocnica S Poliklinikou Nove Zamky	Nove Zamky	Slovakia
Abawi spol. s r.o.	Vrakuna	Slovakia
Ospedale San Raffaele S.r.l.	Milan	Italy
IRCCS Policlinico San Donato	San Donato Milanese	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Semmelweis University	Budapest	Hungary
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove	Czechia
KM Management spol. s r.o.	Nitra	Slovakia
Centre Medico Chirurgical Ambroise Pare Hartmann	Neuilly-Sur-Seine	France
Medrise Sp. z o.o.	Lublin	Poland
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Vrije Universiteit Brussel	Jette	Belgium
Universita Degli Studi Di Brescia	Brescia	Italy
Krajska zdravotni a.s.	Teplice	Czechia
University Hospital Ostrava	Ostrava	Czechia
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
Endomedix Kft.	Budapest	Hungary
Medical Centre Futuremeds EOOD	Plovdiv	Bulgaria
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.	Panagyurishte	Bulgaria
EMC Instytut Medyczny S.A.	Poznan	Poland
Piotr Walczak Gabinet Endoskopii Przewodu Pokarmowego	Cracow	Poland
Gastroenterologische Spezialpraxis-Berlin-Karlshorst	Berlin	Germany
Gydzabrfa Knjbrgz Rgfedhortw Syzkhbgarx Sqk jw	Bialystok	Poland
Cvjzzjlhy Uqrwjlllnvkcmp Sxmwkvehb	Woluwe-Saint-Lambert	Belgium
Obcjquixyvlygm Lbuv Gexp	Linz	Austria
Ibikvlvul Fmx Cguzfwji Ahb Euuweodqnaxg Muoqqvxs	Prague	Czechia
Aruyeuw Spjthpatb Lokwtb Mludxs	Matera	Italy
Odvqgnr Bsylo Kxtsgsrwtrv Bq Rqmuciyh Spp z oqgy	Ilawa	Poland
Vbqkfui Kquf	Szombathely	Hungary
Capmwr Hwcfwnbgnoc En Ujmpophskobbh Dk Lzciqri	Limoges	France
Axrxrgaubu Pctxpujp Hzokmnzx Dh Pvutq	Paris	France
Chenzg Hbzbnrdzyrv Rweewlfw Utngovwygxhrv Dr Tpjul	Tours	France
Cbdw Dj Nifwd	Vandoeuvre Les Nancy	France
Axaeusd Uswie Sddckrnij Lfglim Dr Bhflidi	Bologna	Italy
Cazmqgwn Hnkonhxv Dtxztqm	Zagreb	Croatia

Trial status

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

Trial locations

Investigated drugs:

Ro7790121

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

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