EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease

Study Purpose

A Phase 1, 2-part, multicentre study to evaluate the safety and preliminary efficacy of the oral administration of EXL01 in the maintenance of corticosteroid-induced clinical response/remission in participants with mild to moderate Crohn's Disease (CD).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

Must meet all of the following criteria at the start of the Induction Period:

- Male or female aged ≥18 years and <75 years at the time of providing informed consent.

- A diagnosis of CD with ileal involvement for at least 3 months prior to Screening.

- A CDAI score >180 and <350.

- Active mucosal inflammation.

Key

Exclusion Criteria:

- Stricture with obstructive syndrome <3 months prior to Screening.

- Stenosis making endoscopic access to the terminal ileum difficult.

- Received treatment with high dose corticosteroid (≥40 mg prednisone daily) for >5 weeks within 3 months prior to Screening.

- Received ≥2 prior biologic treatments for CD including infliximab, ustekinumab, vedolizumab, adalimumab, and certolizumab.

- Major surgery or significant trauma ≤4 weeks prior to Screening.

- Small bowel resection >1 m in total or clinical manifestations of short bowel syndrome.

- Current stoma (ileostomy or a colostomy) or had a stoma in the last 6 months or any other intraabdominal surgery within 3 months prior to Screening.

- Started or stopped immunosuppressive therapy (thiopurine, methotrexate, tacrolimus, or other classical immunosuppressant) within 3 months prior to Screening.

- Received faecal microbial transplant within 3 months prior to Screening.

- Systemic infection or other serious infection requiring systemic treatment within 30 days prior to Screening.

- Pregnant, breastfeeding, or expecting to conceive during the study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05542355
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Exeliom Biosciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Acting Chief Medical Officer
Principal Investigator Affiliation	Exeliom Biosciences
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	Belgium, Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn Disease

Additional Details

Initially, all participants will received standard of care (SoC) corticosteroid induction therapy for 3 to 7 weeks. Participants who meet the protocol defined criteria for response after corticosteroid therapy will enter a Maintenance Period. Participants not in clinical response/remission at the end of the Induction Period will discontinue the study without further study treatment. In the Maintenance Period, participants will receive oral EXL01 or placebo in combination with corticosteroid treatment (that is progressively tapered) and be monitored for safety and efficacy. The study will be conducted in 2 parts:

- Part A: Participants eligible for maintenance treatment will receive open-label oral EXL01 for up to 24 weeks.

- Part B: Participants eligible for maintenance treatment will be randomised 2:1 to receive double blind oral EXL01 or placebo for up to 24 weeks.

Participants will be monitored for 30 days after end-of-treatment.

Arms & Interventions

Arms

Experimental: Part A (Open-Label EXL01 Maintenance Therapy)

Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Experimental: Part B (EXL01 Maintenance Therapy)

Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Placebo Comparator: Part B (Placebo Maintenance Therapy)

Oral EXL01 matched placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Interventions

Drug: - EXL01

Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Drug: - Placebo

Oral EXL01 matching placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Other: - SoC corticosteroid - Induction Period

Oral prednisone 40 mg or budesonide 9 mg once daily for 3 to 7 weeks, as assigned by the investigator

Other: - SoC corticosteroid - Tapering

Same product as the Induction Period. Oral prednisone: 30 mg for 1 week, 25 mg for 1 week, 20 mg for 1 week, 15 mg for 1 week, 10 mg for 1 week, 5 mg for 1 week and stop. OR Oral budesonide: 6 mg for 3 weeks, 3 mg for 3 weeks, stop.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.