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

NCT05542355 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-10-10

No results posted yet for this study

Summary

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).

Conditions

  • Crohn Disease

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.

Sponsors & Collaborators

  • Alimentiv Inc.

    collaborator OTHER

  • Exeliom Biosciences

    lead INDUSTRY

Principal Investigators

  • Acting Chief Medical Officer · Exeliom Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2024-10-02
Completion
2024-10-02

Countries

  • Belgium
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05542355 on ClinicalTrials.gov