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Crohn DiseasePhase 2NCT05940558

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

A Phase 2 study testing MBF-118 oral capsules in people with Crohn Disease, run by Medibiofarma S.L. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn Disease
What is being tested?
MBF-118 oral capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSpain
Study dates
12 Apr 2023to 10 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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].
  • Systemic or opportunistic infections including:
  • Patients with active tuberculosis (TB) determined at Screening, defined as a positive QuantiFERON test, or a purified protein derivative (PPD) skin test. Patients who test positive and show symptoms of TB (abnormal chest x-ray, or positive sputum smear or culture, active TB bacteria in his/her body, usually feels sick and may have symptoms such as coughing, fever, and weight loss) will be excluded. Patients positive for TB who develop symptoms during the study period will be removed from the trial. An exception is made for subjects with a history of latent TB who are currently receiving treatment for latent TB, will initiate treatment for latent TB before the first dose of study treatment, or have documentation of completing appropriate treatment for latent TB within 3 years prior to the first dose of study treatment). Patients who test positive for TB during the study period but who do not show symptoms will be allowed to continue the study.
  • Active infection with HIV.
  • Evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). NOTE: if a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if no presence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.
  • Chronic hepatitis C (HCV) (positive HCVAb and HCV RNA). Note: Participants who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured).
  • Evidence of Clostridioides difficile toxin or treatment for C. difficile infection, or other intestinal bacterial pathogen, within 30 days prior to Screening.
  • History of invasive fungal infections such as Candida or Aspergillus within 6 months prior to randomization.
  • History of herpes (simplex type 1, simplex type 2, or zoster) infection or reactivation within 12 weeks prior to randomization, or frequent recurrence of herpes (more than 2 times per year).
  • Evidence of active cytomegalovirus (CMV) infection at Screening.
  • Any other clinically significant extraintestinal infection or opportunistic, chronic, or recurring infection within 6 months before Screening. Examples include, but are not limited to, infections requiring intravenous (IV) antibiotics, hospitalization, or prolonged treatment.
  • Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Screening. Fecal microbiota transplant (includes human microbiota-based therapeutics) within 4 weeks prior to Screening are allowed.
  • Any major surgery, in the investigator's opinion, performed within 8 weeks prior to randomization or planned during the study (i.e., any surgical procedure requiring general anesthesia).
  • Unwillingness to withhold protocol-prohibited medications during the trial.
  • History of excessive alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
  • Known or suspected allergy, anaphylaxis, hypersensitivity or intolerance to the study drug(s) or its' excipients.
  • Prior enrolment in the current study and had received study treatment.
  • The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, Galicia, 15706

Other trials in Spain

About this study

Official title: A Phase IIa, Open Label, Single-centre Study to Assess the Initial Antifibrotic Efficacy, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of MBF-118 in Crohn's Disease Patients with Stenosis

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.

Read the detailed description

This is a Phase 2a study to evaluate the safety, tolerability and exploratory efficacy of daily oral treatment with either 100 mg or 200 mg MBF-118 during 28 days in Crohn's disease patients diagnosed with stenosis, in order to provide reliable safety, tolerability, and PK data that will guide drug dose and therapeutic regimen choices in subsequent clinical studies.

The study design is a single-center, open-label group consisting of two cohorts, one dosed with 100 mg MBF-118 daily for 28 days and one dosed with 200 mg MBF-118 daily for 28 days, in approximately 5 subjects per cohort without placebo control. No randomisation is required. The first five patients to start initiate the trial will be dosed with 100 mg. The subsequent five patients initiating the trial will be dosed with 200 mg.

For each subject, the study duration will last a total of approximately 14-16 weeks consisting of a screening period of 2-4 weeks, a treatment period of 4 weeks and a follow-up period of 8 weeks.

The 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 an open-label 90-day extension phase. The extension phase will last approximately 19-21 weeks consisting of up to 21 days screening, 90 treatment days and 42 follow-up days.

Conditions
Crohn Disease
Being tested
MBF-118 oral capsules
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBF-118 oral capsulesDrug

    MBF-118 oral capsules PPAR gamma receptor partial agonist

Study groups in NCT05940558
Study groupRoleWhat they receive
MBF-118 100mg oral multiple doseExperimentalDrug: 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.
Receives: Drug: MBF-118 oral capsules
MBF-118 200mg oral multiple doseExperimentalDrug: MBF-118 100mg oral capsules. Single daily dose. Two hard gelatin capsules during 28 days
Receives: Drug: MBF-118 oral capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start12 Apr 2023
  3. Primary completion10 Sep 2024
  4. Study completion10 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05940558
Sponsor's protocol ID
MBF-118CT-02
Status last verified
Feb 2025
First submitted
29 Jun 2023
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MBF-118 oral capsules in people with Crohn Disease, run by Medibiofarma S.L. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05940558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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