Study on the Effects of Obefazimod for Patients with Moderate to Severe Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called ABX464 on individuals with moderately to severely active ulcerative colitis. Ulcerative colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine. The medication being tested, ABX464, is taken in the form of a hard capsule and contains an active substance known as obefazimod. The study will also include a comparison with a placebo, which is a substance with no active medication.

The purpose of this study is to evaluate the effectiveness and safety of ABX464 in helping patients achieve clinical remission, which means a reduction or disappearance of symptoms. Participants in the study will take the medication once daily for a period of eight weeks. During this time, researchers will monitor the participants to see how well the medication works in reducing the symptoms of ulcerative colitis and to ensure it is safe for use.

Throughout the study, participants will undergo regular check-ups to assess their health and the progress of their condition. The study aims to determine the proportion of participants who experience significant improvement in their symptoms, as well as any potential side effects. This research is important for understanding how ABX464 can be used to treat ulcerative colitis and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, you will be required to sign a written informed consent form. This document confirms your understanding and agreement to participate in the trial.

You must meet specific criteria, such as being at least 16 years old and having a documented diagnosis of moderately to severely active ulcerative colitis.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests, such as endoscopy and histology, to confirm your condition.

3 randomization

You will be randomly assigned to receive either the study medication, ABX464, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

4 medication administration

You will take the assigned medication orally in the form of a hard capsule once daily. The dosage will be either 25 mg or 50 mg, depending on the group you are assigned to.

The treatment will last for a specified period, with regular monitoring to assess your response and any side effects.

5 regular monitoring

Throughout the trial, you will attend regular study visits. These visits are essential for monitoring your health, assessing the effectiveness of the treatment, and identifying any side effects.

You will undergo various assessments, including clinical evaluations and laboratory tests, to ensure your safety and the study’s integrity.

6 end of treatment evaluation

At the end of the treatment period, a final evaluation will be conducted. This will include a comprehensive assessment of your condition and any changes observed during the trial.

The primary goal is to determine the proportion of participants who achieve clinical remission at week 8, as well as other secondary outcomes.

Who Can Join the Study?

Men or women who are at least 16 years old. If you are under 18, you must weigh at least 40 kg (about 88 pounds) and have reached Tanner Stage 5, which means you have completed physical development.
You must understand and sign a written consent form before any study procedures begin. If you are under the legal age, your parent or guardian must also give consent according to national requirements.
You must have a documented diagnosis of ulcerative colitis (UC) for more than 90 days before starting the study. This diagnosis should be confirmed by a procedure called endoscopy and a tissue examination called histology.
Your disease must be active, which is measured by a modified Mayo score (MMS) of 5 or more, with a rectal bleeding subscore (RBS) of at least 1, and an endoscopy subscore (MES) of 2 or 3. These scores will be confirmed by a central reader.
You must have had an inadequate response, meaning your condition did not improve, got worse, or you could not tolerate at least one of the following treatments: corticosteroids, immunosuppressants, biologic therapies, S1P receptor modulators, JAK inhibitors, or any new drugs approved during the study. Note that failure to respond only to 5-ASA is not enough to qualify.
If you are a woman who can become pregnant or a man with a partner who can become pregnant, you must agree to use highly effective birth control methods as described in the study protocol.
You must be able and willing to attend study visits and follow the study procedures as outlined in the protocol.
You should have health insurance if it is required by the country or state where the study is taking place.

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 a history of severe allergic reactions.
Patients who are currently pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain medications that could affect the study results.
Patients who have had surgery related to ulcerative colitis within the last 6 months.
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
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
IRCCS Policlinico San Donato	San Donato Milanese	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Sint-Lucas General Hospital	Brugge	Belgium
CHC MontLegia	Liege	Belgium
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universita’ Di Pisa	Pisa	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Algemeen Ziekenhuis Klina	Brasschaat	Belgium
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
CHU Saint Pierre	Brussels	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Vrije Universiteit Brussel	Jette	Belgium
Cabinet Medical Van Houte Cornejo Montero	Yvoir	Belgium
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Centrum Medyczne Kuba-Med 2 Sp. z o.o.	Zamosc	Poland
National Institute Of Gastroenterology Saverio De Bellis Research Hospital	Castellana Grotte	Italy
Appletreeclinics Network Sp. z o.o.	Lodz	Poland
Bonifraterskie Centrum Medyczne Sp. z o.o.	Lodz	Poland
Hopital Saint Eloi	Montpellier	France
Centre Hospitalier De Pau	Pau	France
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
Awuuhuavjx Pzeylyzs Hszylkoo Do Pfjxz	Le Kremlin-Bicetre	France
Cqwvmh Hpmsqvurfzs Uiboxwlaybmqg De Diojw	Dijon	France
Eg Gejrd Skj z ovgo	Warsaw	Poland
Auhteji Osegjkshowu Ooycoaif Rciwkds Vxlxk Stmvu Cixnkkvd	Palermo	Italy
Nmsbibv Ryrdfr Ktlkkpl	Bytom	Poland
Biamtlyf Uemiqhlocm Hzpvjaro Crbjpg	Besançon	France
Cwpmuy Hkaqukblvfl Uaqqpznnaewqd Rbhyx	Reims	France
Hfyvpxv Hgeia Manxjm &njhezb 1 rsu Geebshn Eyljnm	Creteil	France
Itlhplju dc Cpywmkmxujdd Hyoullejuii Uurklotwpgvwk dg Shubk Ecbifrl (gbtiwtn	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	31.01.2023
France	Not yet recruiting	31.01.2023
Germany	Not yet recruiting	31.01.2023
Italy	Not yet recruiting	31.01.2023
Poland	Not yet recruiting	31.01.2023
Spain	Not yet recruiting	31.01.2023

Trial locations

Investigated drugs:

Obefazimod

ABX464 is a medication being studied for its potential to help people with ulcerative colitis, a condition that causes inflammation and sores in the colon. This medication is taken once a day and is being tested to see if it can help reduce the symptoms of ulcerative colitis and bring about clinical remission, which means that the symptoms of the disease are reduced or disappear. The study is designed to compare the effects of ABX464 with a placebo to determine its effectiveness and safety for people with moderately to severely active ulcerative colitis.

Investigated diseases:

Colitis ulcerative

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to the formation of ulcers. The disease typically begins in the rectum and may extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can cause frequent and urgent bowel movements. Over time, the condition can lead to complications such as severe bleeding or colon damage.

Trial ID:

2022-500535-36-00

Protocol code:

ABX464-105

NCT ID:

NCT05507203

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Obefazimod for Patients with Moderate to Severe Ulcerative Colitis

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