Study on BI 706321 and Ustekinumab 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 is testing a new treatment approach using a medication called BI 706321, which is taken orally as a film-coated tablet. This medication is being tested in combination with another treatment called ustekinumab, which is already used to help manage Crohn’s Disease. Ustekinumab is given as a solution for infusion or injection. The trial will also include a group of participants who will receive a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of this study is to evaluate the safety and effectiveness of the combination of BI 706321 and ustekinumab over a period of 12 weeks. Participants will be randomly assigned to receive either the combination treatment or the placebo, along with ustekinumab. 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 main goal is to see if the combination treatment can improve the condition of the digestive tract as observed through a procedure called endoscopy, which allows doctors to look inside the digestive tract.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their symptoms. The study will also look at how the body processes the medication and any potential side effects. By the end of the 12-week period, researchers hope to gather enough information to determine if the combination of BI 706321 and ustekinumab is a safe and effective treatment option for people with moderate to severe Crohn’s Disease. This trial is an important step in finding new ways to help manage this challenging condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of Crohn’s Disease for at least three months, checking for elevated C-reactive protein (CRP) or fecal calprotectin levels, and ensuring the presence of mucosal ulcers in the ileum or colon.

2 baseline evaluation

A baseline evaluation is performed to measure the Simple Endoscopic Score for Crohn’s Disease (SES-CD). This score helps in assessing the severity of the disease.

3 medication administration

The trial involves the administration of BI 706321 in the form of film-coated tablets taken orally. This medication is combined with ustekinumab, which is provided as a concentrate for solution for infusion and a solution for injection in a pre-filled pen.

The treatment period lasts for 12 weeks, during which the efficacy and safety of the medication are evaluated.

4 mid-trial assessment

At the midpoint of the trial, an assessment is conducted to monitor the patient’s response to the treatment. This includes checking for any adverse effects and measuring changes in the SES-CD score.

5 final evaluation

At the end of the 12-week treatment period, a final evaluation is performed. This includes measuring the absolute change from baseline in the SES-CD score and assessing for endoscopic and biological remission.

The trial also evaluates clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) score of less than 150.

6 follow-up

After the treatment period, a follow-up is conducted to monitor any treatment-emergent adverse events and to assess the residual effects of the medication.

Who Can Join the Study?

Must have been diagnosed with Crohn’s Disease (CD) for at least 3 months before the first visit. This diagnosis should have been confirmed in the past through procedures like endoscopy (a test that looks inside your digestive tract) or radiology (imaging tests), and supported by histology (examining tissue samples).
Must have elevated levels of CRP (C-reactive protein) which is a marker of inflammation in the blood, at least 5 mg/L, or elevated fecal calprotectin (a marker of inflammation in the stool), at least 250 micrograms per gram.
Must have symptomatic CD, which means a CDAI (Crohn’s Disease Activity Index) score of 150 or higher. This score measures the severity of symptoms.
Must have mucosal ulcers (sores in the lining of the intestine) in at least one part of the ileum (part of the small intestine) or colon, and a SESCD (Simple Endoscopic Score for Crohn’s Disease) score of 7 or higher. For patients with only ileitis (inflammation of the ileum), the score should be 4 or higher.
Must have experience with at least one tumor necrosis factor (TNF) antagonist at a dose approved for CD. This means having used a specific type of medication for CD, even if it was stopped due to lack of response, intolerance, or other reasons.
May be taking a therapeutic dose of certain medications such as oral 5-ASA compounds (used to reduce inflammation), oral corticosteroids (a type of steroid medication), AZA (azathioprine), MP (mercaptopurine), 6-TG (thioguanine), or MTX (methotrexate).
Women who can have children must be willing and able to use highly effective methods of birth control.
Other criteria may also apply.

Who Cannot Join the Study?

Patients who do not have Crohn’s Disease cannot participate. Crohn’s Disease is a condition that causes inflammation in the digestive tract.
Patients who are not in the age range specified for the study cannot participate. The study is for certain age groups only.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who are taking certain medications that might interfere with the study cannot participate.
Patients who have a history of substance abuse or alcohol abuse cannot participate.
Patients who have a history of non-compliance with medical treatments cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
University Hospital Ostrava	Ostrava	Czechia
Ospedale San Raffaele S.r.l.	Milan	Italy
Semmelweis University	Budapest	Hungary
Clinexpert Kft.	Budapest	Hungary
Gyongyosi Bugat Pal Korhaz	Gyongyos	Hungary
Uvjbvjgctj Oe Dxwbzlmc	Debrecen	Hungary
Ceuinnk Uznnqsabvulqjepykayb Bnrwmd Khf	Berlin	Germany
Utakrwdbkfnfbausawvra Hpakfzrxux Aqg	Heidelberg	Germany
Iveglecz fhws Kjnpsbwlw Txckcojhhpzcphphxom ugd Izequyygysfd Uoh grvtf	Ulm	Germany
Uxzacaxyjjxmgfwllexvz Siocaywmaqwhhpegek Arl	Kiel	Germany
Hbrjshiy Uakleazeznagz Dr Lv Pprlxksu	Madrid	Spain
Pzyf Tbhsd Hdjayrlp Uslvjnjsehqh	Sabadell	Spain
Iuilt Oedevzni Susuk Cwrih Dcy Ciwujvni	Negrar di Valpolicella	Italy
Fdjiifat Nhaidpsgx U Sh Avrq V Brlk	Brno-Stred	Czechia
Pazinfqcm Imyyjjot Mjrvshfd Mmcfipglbqck Sxflq Wmsfjeegilrr I Arwealsnhlazd	Warsaw	Poland
Tnlad Pzirlfshgnp Sgjguxznlogq Cyjxynb Mfwtewxh Sqs z ofqw	Szczecin	Poland
Cpnpxue Oqrtzy Zszpxdmqly Ocvxcvpnx Spom &sqggnk Mvrhvyzdd Slf jz	Ksawerow	Poland
Csselvy Mpbnmfmp Kpuymp Rjeosa Bbayujgjbucujz I Eqd Kskqwqwwgc Sgy jy	Bydgoszcz	Poland
Sgpbpap Stt z ozfh	Szczecin	Poland
Mr Bskudfx Skdomd Zhajg Sih jq	Knurow	Poland
Grolfpavdvvfyagvz snekdw	Hradec Kralove	Czechia
Ssmjqmr Sjni	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	15.10.2021
Germany	Not recruiting	15.10.2021
Hungary	Not recruiting	15.10.2021
Italy	Not recruiting	15.10.2021
Poland	Not recruiting	15.10.2021
Spain	Not recruiting	15.10.2021

Trial locations

Investigated Drugs:

BI 706321 is an experimental medication being tested for its potential to help treat Crohn’s Disease. In this trial, it is taken orally for 12 weeks. The goal is to see if it can improve symptoms and help heal the gut lining when used alongside another treatment.

Ustekinumab is a medication already used to treat Crohn’s Disease. It works by targeting specific proteins in the immune system to reduce inflammation. In this trial, it is used as an induction treatment, meaning it helps to start the process of reducing disease activity. The study is testing how well it works in combination with BI 706321.

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 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 can vary greatly among individuals, with some experiencing mild symptoms and others facing more severe challenges.

Trial ID:

2024-512756-38-00

Protocol code:

1425-0003

NCT ID:

NCT04978493

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on BI 706321 and Ustekinumab for Patients with Moderate to Severe Crohn’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?