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Study on the Effectiveness 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 for treating individuals with ulcerative colitis, a condition that causes inflammation and sores in the colon. The study aims to evaluate how effective and safe ABX464 is when taken once daily by people who have moderate to severe symptoms of this disease. Participants in the trial will receive either ABX464 or a placebo, which is a substance with no active medication, to compare the outcomes.

The trial will last for a period of eight weeks. During this time, participants will take the medication in the form of a hard capsule by mouth. The study will monitor the participants’ health and symptoms to see if there is an improvement in their condition. The main goal is to see how many participants achieve clinical remission, which means their symptoms significantly improve or disappear. Additionally, the study will look at other factors such as endoscopic improvement, which involves examining the inside of the colon to check for healing, and any changes in symptoms or side effects experienced by the participants.

Throughout the study, the safety of the participants will be closely monitored, including any adverse events or side effects that may occur. The trial will also assess any significant changes in laboratory tests, vital signs, and heart function. The results of this study will help determine the potential benefits and risks of using ABX464 as a treatment option for people with ulcerative colitis.

1 joining the study

Upon joining the study, you will be required to sign a written informed consent form. This form confirms that you understand the study and agree to participate.

If you are under 18, additional consent from a guardian may be required, depending on local regulations.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of ulcerative colitis and ensuring you meet the study criteria.

Your medical history and current health status will be reviewed, and you may undergo tests such as endoscopy and histology.

3 treatment assignment

You will be randomly assigned to receive either the study medication ABX464 or a placebo. A placebo is a substance with no active medication, used for comparison.

The study is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

4 medication administration

If assigned to the ABX464 group, you will take a hard capsule orally once daily. The dosage will be either 25 mg or 50 mg, as determined by the study protocol.

The treatment period lasts for 8 weeks, during which you will continue taking the medication daily.

5 regular monitoring

Throughout the study, you will attend regular visits to monitor your health and response to the treatment.

These visits may include physical examinations, laboratory tests, and questionnaires about your symptoms and overall well-being.

6 end of treatment evaluation

At the end of the 8-week treatment period, a final evaluation will be conducted to assess the effects of the treatment.

This evaluation will include a review of your symptoms, any side effects experienced, and the results of any tests performed.

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 meet the definition of Tanner Stage 5, which means you have reached full physical maturity.
  • You must understand and sign a written consent form before any study procedures begin. If you are under the legal age, your country’s consent requirements must also be met.
  • 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.
  • You must have active disease, 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 the treatment did not work well enough, 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 accepted.
  • 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 might 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 substance abuse or alcohol abuse.
  • Patients who have a known infection with HIV, hepatitis B, or hepatitis C.
  • Patients who have had a major surgery within the last 6 months.
  • Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
DRK Kliniken Berlin Berlin Germany
Centre Hospitalier Universitaire De Lille Lille France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Centre Hospitalier Universitaire De Nice Nice France
Santa Sp. z o.o. sp. K.Polimedica PTG Kielce Kielce Poland
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Centre Hospitalier Universitaire De Toulouse Toulouse France
Universita’ Campus Bio-medico Di Roma Rome Italy
Centre Hospitalier Regional Universitaire De Nancy Nancy France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
ASST Fatebenefratelli Sacco Milan Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
Charite Research Organisation GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Algemeen Ziekenhuis Delta Roeselare Belgium
Az Maria Middelares Gent Gent Belgium
AZ Sint-Lucas & Volkskliniek Gent Belgium
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Area Sanitaria De Ferrol Ferrol Spain
Siloah St Trudpert Klinikum Pforzheim Germany
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Mz Badania Slowik Zymla Sp. j. Knurow Poland
medius KLINIKEN gGmbH Kirchheim Unter Teck Germany
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hôpital Pontchaillou-CHU Rennes Rennes France
Cmdlci Hpmkapltowm Uorblhkokfbgq Akfcte Pwwxhvue Amiens France
Pkrhwy Suxh Gdynia Poland
Auquxcw Ojssmuwdevt Nyyorwkdd Sf Alvfhcq E Blynqv E C Aidbyl Autxiuxcmfb Alexandria Italy
Asjuicoajs Pyeqevlw Hozkrwqk Dv Mjcjlkxve Marseille France
Akmtmpm Utcsy Skmecuqyo Lpcwuj Di Broklfc Bologna Italy
Ulchkwjbzsvkkixxrqfgx Azsvtxbv Augsburg Germany
Unynovitnp Myfdc Gnsghoa Ox Cvygjxfzn Catanzaro Italy

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
15.02.2023
France France
Not yet recruiting
15.02.2023
Germany Germany
Not yet recruiting
15.02.2023
Italy Italy
Not yet recruiting
15.02.2023
Poland Poland
Not yet recruiting
15.02.2023
Spain Spain
Not yet recruiting
15.02.2023

Trial locations

Investigated drugs:

ABX464 is a medication being studied for its potential to help people with ulcerative colitis, which is 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, meaning the symptoms are reduced or disappear. The study is comparing the effects of ABX464 to a placebo to determine how effective it is in treating this condition.

Investigated diseases:

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:
2022-500536-11-00
Protocol code:
ABX464-106
NCT ID:
NCT05507216
Trial Phase:
Therapeutic confirmatory (Phase III)

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