A Study of MB-001 in Moderately to Severely Active Ulcerative Colitis

NCT07374471 | Recruiting Phase 1 DMC

• 2 other identifiers: MB-001-1022025-524719-35-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if MB-001, an oral biologic, is able to treat patients with ulcerative colitis. Participants will be asked to take MB-001 or a matching placebo once-daily for a period of 12 weeks. Researchers will compare MB-001 to placebo to investigate its effects on clinical symptoms as well as endoscopic and histopathological findings. Patients will be offered open-label extension for another 12 weeks following the double-blind, placebo-controlled part of the study. Participants will keep a daily diary to record their symptoms and will have up to nine clinic visits.

Conditions

Ulcerative Colitis (UC)

Keywords

Efficacy study; Oral biologic; Ulcerative Colitis; IBD

Outcome Measures

Primary Outcomes (9)

• Incidence of adverse events

  All adverse events and serious adverse events will be collected from the signing of the ICF until the safety follow-up visit

  From study start until 4 weeks after end of treatment

• Changes in laboratory parameters: Platelet count

  Week 12

• Changes in laboratory parameter: Hemoglobin

  Week 12

• Changes in laboratory parameter: Hematocrit

  Week 12

• Changes in laboratory parameter: Red Blood Cell (RBC) count

  Week 12

• Changes in laboratory parameter: Prothrombin time

  Week 12

• Number of participants with abnormal laboratory tests results

  Blood urea nitrogen, potassium, creatinine, creatinine phosphokinase, sodium, calcium, glucose, uric acid, AST/serum glutamic-oxaloacetic transaminase, ALT/serum glutamic-pyruvic transaminase, Gamma-glutamyl transferase/transpeptidase, alkaline phosphatase, bilirubin, protein, triglycerides, cholesterol, high-density lipoprotein, low-density lipoprotein

  Week 12

• Number of participants with abnormal urinalysis results

  Specific gravity, pH, colour, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase

  Week 12

• Proportion of participants achieving clinical remission

  Defined by a modified Mayo Score (mMS) of not more than 2 with a Mayo endoscopic subscore (MES) not more than 1, rectal bleeding (RB) subscore of 0, and stool frequency (SF) subscore not more than 1. The mMS ranges from 0 to 9. Higher values are worse.

  Week 12

Secondary Outcomes (5)

• Proportion of participants achieving endoscopic improvement

  Week 12

• Proportion of participants achieving endoscopic remission

  Week 12

• Proportion of participants achieving histologic remission

  Week 12

• Proportion of participants achieving histologic-endoscopic mucosal improvement

  Week 12

• Proportion of participants achieving mucosal healing

  Week 12

Other Outcomes (2)

• Area under the plasma concentration-time curve

  Week 12

• Levels of Anti-Drug Antibodies (ADAs)

  Week 12

Study Arms (2)

MB-001 capsules

EXPERIMENTAL

oral capsule formulation

Biological: MB-001

Matching placebo

PLACEBO COMPARATOR

Biological: Matching placebo to MB-001

Interventions

MB-001 BIOLOGICAL

oral capsule formulation

MB-001 capsules

Matching placebo to MB-001 BIOLOGICAL

oral capsule formulation

Matching placebo

Eligibility Criteria

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

You may qualify if:

• Nonpregnant, nonlactating adults with a diagnosis of UC extending ≥ 15 cm from the anal verge, established at least 3 months prior to Screening by clinical and endoscopic evidence of UC (colonoscopy or flexible sigmoidoscopy) and confirmed by histology.
• Moderately to severely active UC, defined as an mMS of 5 to 9, inclusive, with MES of at least 2 and RB subscore of at least 1.
• At Screening, a colonoscopy will be required if the participant has had extensive colitis or pancolitis of \> 8 years duration or left-sided colitis of \> 12 years duration but has not had a colonoscopy within 1 year of the initial Screening visit. If the participant has had a colonoscopy within 1 year of the initial Screening date, a flexible sigmoidoscopy may be used instead.
• Demonstrated, in the opinion of the investigator, an inadequate response, loss of response, or intolerance/medical contraindication to at least 1 of the following treatments at doses approved for the treatment of UC:
• Oral 5-ASA compounds or sulfasalazine
• Oral corticosteroids (eg, prednisone, budesonide)
• Immunosuppressants (eg, AZA, 6-MP, MTX)
• An approved anti-integrin antibody (eg, vedolizumab)
• An approved anti-IL-12/23 antibody (eg, ustekinumab)
• An approved anti-IL-23 p19 antibody (eg, risankizumab, guselkumab, or mirikizumab)
• Participant may be receiving a therapeutic dosage of the following drugs:
• Oral 5-ASA compounds or sulfasalazine, prescribed dose must be stable for at least 2 weeks before Screening endoscopy or stopped at least 2 weeks prior to Screening endoscopy
• Oral corticosteroids - prednisone (max. 20 mg/day) (or equivalent) or budesonide (max. 9 mg/day) and have been at a stable dose for at least 2 weeks prior to Screening endoscopy or stopped at least 2 weeks prior to Screening endoscopy
• Immunosuppressants (AZA, 6-MP, MTX) if the prescribed dose has been stable for at least 8 weeks before Screening endoscopy or stopped at least 8 weeks prior to Screening endoscopy
• POCBP:

You may not qualify if:

• The following complications:
• Acute severe ulcerative colitis, defined by at least 6 bloody diarrhea/day AND any 1 of the following criteria: pulse \> 90 beats/min, temperature \> 37.8°C, hemoglobin \< 105 g/l, erythrocyte sedimentation rate \> 30 mm/h, or C-reactive protein \> 30 mg/l, or in the investigator's opinion, hospitalization for the treatment of UC may be imminent
• Previous extensive colonic resection (subtotal or total colectomy)
• Short bowel syndrome
• Ileostomy, colostomy, ileoanal pouch, fistulae, or known fixed symptomatic stenosis of the intestine
• Toxic megacolon or recent history (within less than 6 months) of toxic megacolon or bowel perforation
• Diagnosis of CD or the presence or history of a fistula consistent with CD, indeterminate colitis, ischemic colitis, NSAID-induced colitis, idiopathic colitis (ie, colitis not consistent with UC), radiation colitis, microscopic colitis, infectious colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
• Primary sclerosing cholangitis with uncontrolled liver function
• Malignancies or history of malignancy within 5 years of Screening (including solid tumors and hematological malignancies), except for adequately treated or completely excised nonmetastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
• History of adenomatous polyps, unless removed.
• History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
• Class III or IV cardiovascular morbidity.
• Clinically significant abnormal vital signs, physical examination, or 12-lead ECG at Screening or Day 1 (prolonged QTc using Fredericia's formula \[\> 460 ms for males and \> 470 ms for females\]), or conditions leading to additional risk for QT prolongation (eg, congenital long-QT syndrome). Participants with electrolyte abnormalities such as hypokalemia and hypomagnesemia that would increase the risk of QT prolongation should be corrected prior to randomization (an ECG may be repeated after electrolyte correction for determining eligibility, if needed).
• History of bleeding disorders (eg, complement disorders, hemophilia, history of uncontrolled bleeding).
• History of any major neurological disorders including stroke, epilepsy, or demyelinating or neurodegenerative disease.

Sponsors & Collaborators

• Mage Biologics: lead

Study Sites (1)

Site 3001

Chisinau, Moldova

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Johannes Spleiss, MSc

CONTACT

+41 78 6478662; johannes.spleiss@magebiologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 28, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: from 2019 onwards
• Access Criteria: Researches based on a synopsis as well as evidence of funding

Locations

MO (1)