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

Inclusion criteria

• . 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.

Exclusion criteria