A multi-center exploratory study to evaluate the efficacy of colchicine in inflammatory bowel disease

JRCT ID: jRCTs061240020

Registered date:06/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Inflammatory bowel disease
• Date of first enrollment: 05/08/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Colchicine taken orally

Outcome(s)

• Primary Outcome: Proportion of patients with a clinical response by Patient-Reported Outcome 2 (PRO2) score 14 days after study drug administration

Secondary Outcome

Proportion of patients with clinical response by PRO2 score 14 days after study drug administration for each UC and CD
Proportion of patients with clinical response by partial Mayo score or Harvey Bradshaw index after 14 days after study drug administration
Proportion of patients with clinical response by PRO2 score 14 days after increasing the dose of the study drug (28 days after starting the study drug)
Proportion of patients with clinical remission by PRO2 score and partial Mayo score or HBI at 28, 56, and 84 days after study drug administration
Proportion of patients with endoscopic remission 84 days after study drug administration
Proportion of patients with improvement in extraintestinal complications after study drug administration
Association between patient background and therapeutic efficacy of the study drug
Safety
Exploration of predictive factors for efficacy of study drug using multi-omics analysis

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with mild or moderate IBD who are untreated or non-responsive or intolerant to treatment with 5-ASA
Patients 16 years and older
Patients with preserved function of major organs such as heart, lungs, liver, and kidneys.
Patients who have obtained written consent from the study subjects themselves. In the case of minors, consent must also have been obtained from a surrogate.

Exclude criteria

Patients who have received treatment for IBD other than 5-ASA within the previous month.
Patients with liver or kidney damage who are taking drugs that inhibit the hepatic metabolic enzyme CYP3A4 or P-glycoprotein.
Patients whose dosage, administration, or formulation of 5-ASA has been changed within 2 weeks prior to the administration of the study drug.
Patients with bleeding tendency or on antithrombotic drugs
Patients with cancer
Patients with hypersensitivity to colchicine
Patients with serious infections
Patients taking other study drugs.
Pregnant or lactating women, or women of childbearing potential.
Patients deemed ineligible by the principal investigator or subinvestigator of the study

Related Information

• Primary Sponsor: Nakase Hiroshi