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).
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. Due to the low recruitment rate into Part A, the study was discontinued early; Part B did not start.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).
Oral EXL01 matching placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy).
Oral prednisone 40 mg or budesonide 9 mg once daily for 3 to 7 weeks, as assigned by the investigator
CHU de Liege
Liège, Belgium
Zespół Poradni Specjalistycznych REUMED
Lublin, Poland
Centrum Medyczne "Medyk" Sp. zo.o. Sp.K
Rzeszów, Poland
Endoskopia Sp. z o. o., Ul. B.Chrobrego 6/8
Sopot, Poland
The systemic and intestinal safety and tolerability of orally administered EXL01
Number of participants with adverse events (AE\[s\]). Number of participants with treatment discontinuations due to an AE. AEs assessed by CTCAE v5.0
Time frame: Up to 43 weeks
Proportion of participants in steroid-free clinical remission at Week 24
Endpoints: Crohn's disease activity index (CDAI) score (higher scores indicate more active/severe disease) and use of corticosteroids
Time frame: Maintenance Period Week 24
Proportion of participants in steroid-free clinical remission and mucosal healing at Week 24
This is a composite measure. Endpoints: CDAI score, simple endoscopic score for Crohn's Disease (SES-CD; higher scores indicate more severe disease), and use of corticosteroids
Time frame: Maintenance Period Week 24
Proportion of participants in steroid free clinical remission and mucosal healing and normal inflammatory markers at Week 24
This is a composite measure. Endpoints: CDAI score, SES-CD score, C-reactive protein (CRP) level (a marker of inflammation), faecal calprotectin level (a marker of intestinal inflammation), and use of corticosteroids
Time frame: Maintenance Period Week 24
Proportion of participants with an endoscopic response at Week 24
Endpoint: SES-CD score
Time frame: Maintenance Period Week 24
Time to clinical relapse in participants with CD treated with EXL01 to participants treated with placebo (Part B only)
Time to clinical relapse, defined as the time from first dose of EXL01 or placebo to first documented clinical relapse (Part B only)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
PlanetMed Sp.z.o.o. Gastroenterology, Ul.Lubinowa 12/8
Wroclaw, Poland
Time frame: Maintenance Period Baseline to Week 24
Comparison of the SES-CD and histology of the intestinal mucosa in participants with CD treated with EXL01 to participants treated with placebo (Part B only)
This is a composite measure. Endpoints: SES-CD score, Robarts Histopathology Index score (measures histological disease activity; higher scores indicate more severe disease activity)
Time frame: Maintenance Period Baseline to Week 24
Comparison of the evolution of the faecal and mucosa-associated microbiota in participants with CD treated with EXL01 to participants treated with placebo (Part B only)
This is a composite measure. 16S sequencing / shotgun metagenomics and specific quantitative polymerase chain reaction (qPCR)/digital droplet (dd)PCR
Time frame: Maintenance Period Baseline to Week 24