Safety and Efficacy of MBF-118 in Patients with Crohn Disease

NCT05940558 | Completed Phase 2

• 1 other identifier: MBF-118CT-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase IIa (proof of concept), single center clinical trial to evaluate the safety and efficacy of daily MBF-118 oral treatment during 28 days in Crohn's disease patients on top of standard of care.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events

  Evaluate the safety of MBF-118 administered for 28 days in subjects with Crohn's disease by assessing the number, severity, and type of adverse events.

  12 weeks

Study Arms (2)

MBF-118 100mg oral multiple dose

EXPERIMENTAL

Drug: MBF-118 100mg oral capsules. Single daily dose. One hard gelatin capsules during 28 days. Subjects who have previously completed 28 days treatment with 100 mg MBF-118 and did not show any serious adverse effects will have the option to participate to a 90-day treatment.

Drug: MBF-118 oral capsules

MBF-118 200mg oral multiple dose

EXPERIMENTAL

Drug: MBF-118 100mg oral capsules. Single daily dose. Two hard gelatin capsules during 28 days

Drug: MBF-118 oral capsules

Interventions

MBF-118 oral capsules DRUG

MBF-118 oral capsules PPAR gamma receptor partial agonist

MBF-118 100mg oral multiple dose; MBF-118 200mg oral multiple dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet each of the following criteria for enrolment into the study:
• Male or nonpregnant, nonlactating females, age 18-75. Males and females of childbearing potential must agree to use adequate birth control measures during the study. Females of childbearing potential must have a negative serum pregnancy test prior to Visit 2 and either be sexually abstinent or must use a hormonal (oral, implantable, or injectable) or double barrier method of birth control throughout the study, and until 60 days after the last dose of study drug. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or postmenopausal \[defined as a minimum of 1 year since the last menstrual period\]).
• Diagnosis of CD based on clinical, endoscopic, and histologic evidence established at least 3 months prior to Screening.
• Has mild to severe ileal and/or colonic CD.
• Participant has no more than 4 naïve or anastomotic small bowel strictures by MRE or IU in the terminal ileum at Screening. A stricture is defined as:
• localized luminal narrowing (luminal ≤ 50% relative to normal adjacent bowel); AND
• wall thickening (≥ 125% relative to adjacent bowel); AND
• length \< 20 cm
• If participants are using a treatment for CD, they should be on a stable dose for at least 3 months prior to study commencement. Acceptable treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and anti-inflammatory biologics.
• Ability to participate fully in all aspects of this clinical trial. Full comprehension of consent language and written informed consent must be obtained from the participant and documented.

You may not qualify if:

• Participants who exhibit any of the following conditions are to be excluded from the study:
• CD-related complications:
• Previous ileorectal anastomosis, or a proctocolectomy. Patients who have received colonic resection are allowed in this study.
• Short bowel syndrome
• Ileostomy, colostomy, small bowel stoma, or ileoanal pouch
• Fistulae in or adjacent to an ileal stenosis. Participants with perianal fistulae could be included if not septic. Participants with internally penetrating fistulae are excluded.
• Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated
• Toxic megacolon
• Use of corticosteroid treatment for symptoms of inflammatory bowel disease within the last 2 weeks. Corticosteroids should not be taken during the screening, treatment or follow-up periods of the trial.
• History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID)-induced colitis, idiopathic colitis (i.e., colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
• Uncontrolled primary sclerosing cholangitis.
• Malignancies or history of malignancy within 5 years of the initial screening visit (V1), except for adequately treated or completely excised non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
• Has a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, as determined by the investigator.
• Patients with cardiac failure or history of cardiac failure (New York Heart Association (NYHA) stages I to IV congestive heart failure) and patients with prior myocardial infarction or symptomatic coronary artery disease.
• Clinically significant abnormal clinical laboratory values, vital signs, physical examination, or 12-lead electrocardiogram (ECG) at Screening or Baseline \[PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradycardia (\<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval\].

Sponsors & Collaborators

• Medibiofarma S.L.: lead

Study Sites (1)

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Galicia, 15706, Spain

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 11, 2023
• Study Start: April 12, 2023
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)