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 obefazimod, also known by its code name ABX464. This treatment is being tested to see how effective and safe it is for people with moderately to severely active Crohn’s disease who have not responded well to other treatments.
The purpose of the study is to compare the effects of obefazimod with a placebo in managing Crohn’s disease symptoms. Participants will take the medication in the form of a hard capsule, which is taken orally. The study will be conducted in phases, including an induction phase to start the treatment, a maintenance phase to continue the treatment, and an extension phase to further evaluate safety and tolerability. The study will last for a period of up to 100 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment.
Throughout the study, researchers will assess various aspects of the treatment, such as its ability to reduce disease activity and improve symptoms. They will also monitor for any side effects or adverse events to ensure the safety of the participants. The ultimate goal is to determine if obefazimod can be a beneficial treatment option for those living with Crohn’s disease.
1induction phase
During this phase, the effectiveness of obefazimod is compared to a placebo. The goal is to see how well the treatment works for those with moderate to severe Crohn’s disease.
Participants will take obefazimod in the form of a hard capsule, administered orally. The specific dosage and frequency will be determined by the study protocol.
This phase lasts for 12 weeks, during which changes in the Crohn’s Disease Activity Index (CDAI) score will be monitored.
2maintenance phase
Following the induction phase, the maintenance phase continues to evaluate the long-term effectiveness of obefazimod compared to a placebo.
Participants will continue taking the medication as prescribed, with the same form and route of administration.
This phase extends to 52 weeks, with ongoing assessments of CDAI scores and other health indicators.
3extension phase
In this phase, the focus shifts to assessing the safety and tolerability of obefazimod over a longer period.
Participants who continue into this phase will maintain their treatment regimen, with regular monitoring for any adverse effects.
The duration of this phase is not specified, but it aims to provide additional data on the long-term use of the medication.
Who Can Join the Study?
Must be a male or female, aged between 18 to 75 years old.
Must understand, sign, and date a written voluntary informed consent form, and be able and willing to attend study visits and follow procedures as outlined in the study plan.
Must have a confirmed and documented diagnosis of Crohn’s disease based on tests called endoscopy and histology reports. If there is no documented diagnosis, it must be confirmed during the screening with local tests.
Must have moderately to severely active Crohn’s disease, which is measured by specific scores: a CDAI score between 220 and 450, and a SES-CD score of 6 or more for certain types of the disease, or 4 or more for another type, as determined by a central reading.
Must have a documented inadequate response, meaning no response, loss of response, or intolerance, to at least one of the following treatments: corticosteroids, immunosuppressants, biologic or biosimilar therapies, janus kinase inhibitors, or new drugs approved for Crohn’s disease during the study. Note that failure to only 5-ASA is not accepted.
Women who can have children and men with partners who can have children must agree to follow contraception requirements as stated in the study plan.
Must be affiliated with a health insurance policy if required by the country or state participating in the study.
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 experiencing moderately to severely active symptoms of Crohn’s disease are excluded. This means their symptoms are not severe enough to qualify.
Patients who have had an adequate response to conventional or advanced therapies are not eligible. This means if their current treatments are working well, they cannot join.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Both male and female patients are eligible, but those who do not meet other criteria will be excluded.
Patients who are part of a vulnerable population, such as those unable to give consent, are not included in the study.
Obefazimod is a medication being studied for its potential to help people with moderately to severely active Crohn’s disease. This medication is being tested to see if it can effectively reduce the symptoms of Crohn’s disease in patients who have not had success with other treatments. The study aims to determine how well obefazimod works in both the initial treatment phase and the longer-term maintenance phase. Additionally, the study will assess the safety and tolerability of obefazimod for those who continue using it in an extended phase of the trial.
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 active phases, 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 is unpredictable, with some people experiencing long periods of remission and others having frequent flare-ups.
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