Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis

NCT05915104 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: REB22-1240
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to compare how well two formulations of budesonide (budesonide MMX \[Cortiment\] and budesonide CR \[Entocort\]) work for treating patients with microscopic colitis.

Conditions

Microscopic Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  Hjortswang criteria defines clinical remission as a daily average \<3 loose/watery bowel movements per 24 hours in the week preceding the final assessment (loose/watery stool consistency will be measured using the Bristol Stool Chart (types 6 and 7)

  Week 8

Secondary Outcomes (4)

• Histologic remission

  Week 8

• Histologic response

  Week 8

• Clinical response

  Week 8

• Patient-reported symptom improvement

  Week 8

Study Arms (2)

Budesonide MMX®

EXPERIMENTAL

Participant received 9 mg delayed and extended-release tablet, once daily, oral administration, for 8 weeks

Drug: Budesonide MMX®

Budesonide controlled ileal release (CR) capsules

ACTIVE COMPARATOR

Participant received three 3 mg capsules, daily oral administration, for 8 weeks

Drug: Budesonide controlled ileal release (CR) capsules

Interventions

Budesonide MMX® DRUG

9 mg delayed and extended-release tablet once daily

Also known as: Cortiment®

Budesonide MMX®

Budesonide controlled ileal release (CR) capsules DRUG

three 3 mg capsules daily oral administration for 8 weeks

Also known as: Entocort®

Budesonide controlled ileal release (CR) capsules

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating females, 18-80 years old years of age
• Females of childbearing potential must be taking adequate contraceptive precautions (i.e., implants, injectables, hormonal intrauterine devices, combined hormonal contraceptives, having a vasectomized partner or total abstinence from heterosexual relations with no plans of becoming pregnant through insemination or in vitro fertilization) and have a negative urine pregnancy test prior to randomization.
• Active symptoms of MC defined by non-bloody, watery diarrhea or loose bowel movements for at least 12 weeks (for patients with newly diagnosed MC) or a history of clinical relapse for at least one week before randomization in patients with previously established MC, and with \>=28 stools within 7 days preceding randomization, of which \>=20 were watery/soft stools
• Colonoscopy or flexible sigmoidoscopy with histologically confirmed MC, defined by signs of inflammation of the lamina propria and either:
• lymphocytic colitis: ≥20 IELs/100 surface epithelial cells
• collagenous colitis: subepithelial collagen band \>10 micrometers in diameter
• Ability of subject to participate fully in all aspects of this clinical trial
• Written informed consent must be obtained and documented

You may not qualify if:

• Evidence of infectious diarrhea (proved by stool culture or colonic biopsy), diarrhea due to other organic diseases of the gastrointestinal tract including Crohn's disease, ulcerative colitis, ischemic colitis, Celiac disease (ruled out by either duodenal biopsy or serum antibodies), radiation colitis, or polyps \>2cm, suspicion of drug-induced MC
• History of partial or total colonic resection
• Previous exposure to \>7 days of any budesonide formulation for treatment of MC
• Unwillingness to withhold protocol-proscribed medications during the trial
• Received any of: aminosalicylates, corticosteroids (other than budesonide), immunosuppressants (including thiopurines and methotrexate), bismuth subsalicylate, cholestyramine, biological treatments, or antibiotics (except for up to a 7-day course for conditions unrelated to microscopic colitis) within 8 weeks of randomization
• Use of loperamide or diphenoxylate/atropine as an anti-diarrheal agent is not permitted during the screening period
• Serious underlying disease other than MC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study, including a history of:
• Severe anaemia (haemoglobin \< 90 g/L) or leukopenia (white blood cell count \< 2.5 x 109 cells/L)
• Known infection with hepatitis B, hepatitis C, or human immunodeficiency virus not on effective anti-viral therapy
• Active malignancy
• Cirrhosis or significant hepatic or renal insufficiency
• Poorly controlled type 1 or type 2 diabetes
• Glaucoma
• History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
• Pregnant or lactating women

Sponsors & Collaborators

• University of Calgary: lead
• Ferring Pharmaceuticals: collaborator

MeSH Terms

Conditions

Colitis, Microscopic

Interventions

Capsules; Budesonide

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Christopher Ma, MD MPH

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Ma, MD MPH

CONTACT

403-592-5013; christopher.ma@ucalgary.ca

Katherine Buhler

CONTACT

kaewert@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All qualified participants will be randomly assigned in a 1:1 ratio to receive budesonide MMX® or budesonide CR. Blocked randomization (block size of 8) will be stratified on disease subtype (collagenous colitis vs. lymphocytic colitis). Randomization will be conducted through the REDCap® clinical trials randomization module, which will generate a random, blinded allocation sequence that will be concealed to both investigators and participants. An independent pharmacist will prepare all treatment packages. Budesonide will be packaged into 4-week increments (two packages per 8-week treatment course). These treatment packages will be identical in appearance and size and labelled with a randomly generated study identification number. Investigators will not know the contents of each treatment package. At the randomization visit, eligible participants will be randomized and be given the corresponding treatment package. Participants will not be blinded to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This phase 2a trial is a prospective, randomized, single-blinded (investigator-blinded), active comparator clinical study. Eligible participants with active Microscopic Colitis will be randomized 1:1 to receive either budesonide MMX® or budesonide CR 9 mg daily for 8 weeks.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available and stored for 15 years after the study completion