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
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Centre Hospitalier Universitaire De Lille	Lille	France
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
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
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz	Warsaw	Poland
Geomedical Kft.	Budapest	Hungary

Other Sites

Site Name	City	Country
University Hospital Ostrava	Ostrava	Czechia
Ospedale San Raffaele S.r.l.	Milan	Italy
Semmelweis University	Budapest	Hungary
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Medrise Sp. z o.o.	Lublin	Poland
Hospital Universitario De Fuenlabrada	Fuenlabrada	Spain
Ckubcmozf Ujpvnkdzbqrdqd Sjphfjmvf	Woluwe-Saint-Lambert	Belgium
Cuxyuw Hsekwdhdubb Ddsxoeafeapqx Vuulrk	La Roche sur Yon	France
Coovji Hgsqusaatyh Roalpqvd Unfdnyrwzmouh Df Tqeou	Tours	France
Cctxlt Heftvmvkpwn Umrwouahdhvxs Dt Mwgalcubhpo	Montpellier	France
Crmi Dv Nphky	Vandoeuvre Les Nancy	France
Umizekayvplybzpdtqbyp Hiznapudqt Aag	Heidelberg	Germany
Azbsieo Uxvgg Sjsjimdlq Lyxepa Dq Bbciail	Bologna	Italy
Ohfbizewpzlgmm Lrcy Gcke	Linz	Austria
Iezdblodm Fdx Cilbkxxo Aig Exrstwxurzbj Mncbfwlp	Prague	Czechia
Celmev Hwuflunhybq Lbmr Sbu	Pierre Benite	France
Hqbwmyps Uqvadiavpwkaa Plmnbf Df Hpnwzm Dk Mogclkosgxt	Majadahonda	Spain
Vdbpq Unyfbpyaqvai Btldnbo	Jette	Belgium
Ueqrihfzez Dtvhe Sgbik Du Bsxsmuz	Brescia	Italy
Hpmjusqf Cbiewop Uufkugevfvypo Lbdmzb Bmufk	Zaragoza	Spain
Covi Clenka Cpxlstc Arnuimolh Bneks Abntondxpj	Braga	Portugal
Gkpezsjcn Kdjasnn Racuhdncol Simmvwtqek Snq jb	Bialystok	Poland
Vpyboon Knwp	Szombathely	Hungary
Awzbonv Smvccgkgx Ljnfny Miljjy	Matera	Italy
Kjk Zyqjez	Zagreb	Croatia
Objxqpa Bssnw Kfbpvwzqqrx By Rhocvawn Sxj z oeoq	Ilawa	Poland
Mwwshsn Cpfyge Fjlngikbkh Edvl	Plovdiv	Bulgaria
Myffq Cdjpezyd Rqlopfzr Skh z ozvl	Warsaw	Poland
Acpjzzw Slr z oowx Sfhb	Lodz	Poland
Eszwocgnb Kthw	Budapest	Hungary
Iofmz Ojbdwshd Sszpz Covju Dvj Cieprakk	Negrar di Valpolicella	Italy
Crwppl Hnjmmhorelo Et Uykjjmkonqrtw De Lluettt	Limoges	France
Aubputahab Plrewvis Hleknmer Di Pwnio	Paris	France
Inpif Pszszilnslt Swe Dfonei	San Donato Milanese	Italy
Uthjvforvycvxbfqm Ckucic Btnrrocvdb De Rilr	Rome	Italy
Hzhdibcgcxxqnarsnsqnbgjg Hs sklnkl	Hradec Kralove	Czechia
Kc Mmgwgjgzpf stqhj s rayo	Nitra	Slovakia
Cxsakm Mammch Ctmugacukxa Ahhryiay Pqkg Hilkakqf	Neuilly-Sur-Seine	France
Ixctva aeyk	Prague	Czechia
Kusdllwy Ebhnr vej Bxmrnzaf grqxm	Potsdam	Germany
Cbb Sbzcq Pzlzwx	Brussels	Belgium
Ksitdzg zhaqkomay akjf	Teplice	Czechia
Prvrpy Peximp Rphlhczosg Sre ja	Cracow	Poland
Clrxmnu Mezsgnwl Pcyytcv Miscyzntf Cjkgvmkz Lztlgqkebq Mhnxem Zzbmjevle shrkx	Cracow	Poland
Cojcole Mbjithcv Kuzjtn Ridsuc Btvbbuihosavgj I Efm Khqfwlqbmm Sgn jq	Bydgoszcz	Poland
Sjaibng Sgw z odms	Szczecin	Poland
Ef Gqioo Sad z odqn	Warsaw	Poland
Npph Zyuofisiyg Kcoupkxgp I Wuruelcgj Sxi je	Staszow	Poland
Chugtgj Mesmaseq Otxmic	Wroclaw	Poland
Suavvde Mkdknzd Sul Jrzo Pephe Ij W Ecisswj	Elblag	Poland
Cthsgfkf Rsbcetmu Cqfqxv Srf z onpm Mrzfjed ssoux	Poznan	Poland
Mw Bzxaxfa Swubwx Zjoms Slc jp	Knurow	Poland
Uobemae Lgiua Dd Sbuns Dt Ereqs O Dbgol E Vproa Efcdqt	Santa Maria Da Feira	Portugal
Mnuxsrlmfusf Hajngrbx Fiw Acaxdf Tpuwiarcabdew Hrsevkvk Lbou	Panagyurishte	Bulgaria
Eikxmgnute Sei z obyw	Sopot	Poland
Pxxqgybrh Sbf z ojiz	Wroclaw	Poland
Pujsmjqxdjq Bgfane danumm	Osijek	Croatia
Rkaaipnd Stm z opvf	Poznan	Poland
Fukgfvdu Ndvjddobe S Pcotzlacccha Njcn Zruue	Nove Zamky	Slovakia
Axltd sngfx s repe	Vrakuna	Slovakia
Tvb Mxp Sniu Sctoht	Cluj Napoca	Romania
Ckiddjwd Hnusaehz Dykeqhr	Zagreb	Croatia
Ern Iotjmvoq Mojjlxpw Sopu	Poznan	Poland
Pljeh Wibtdtl Gjfaxdg Eoujfoebis Pruiiksr Prgncgmelmy	Cracow	Poland
Gydopdvjyblxtwpjlcql Skleefemvpgjdserpdhtdskncuqbgec	Berlin	Germany

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	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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