MB-001 for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- Nonpregnant, nonlactating adults (18 to 75 years of age, inclusive) 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\n- Moderately to severely active UC, defined as an mMS of 5 to 9, inclusive, with MES ≥ 2 and RB subscore ≥ 1\n- 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.\n- 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-aminosalicylic acid compounds or sulfasalazine; corticosteroids (eg, prednisone, budesonide); immunosuppressants (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]); an approved anti-integrin antibody (eg, vedolizumab); an approved anti-interleukin (IL)-12/23 antibody (eg, ustekinumab); an approved anti-IL-23 p19 antibody (eg, risankizumab, guselkumab, or mirikizumab); an approved sphingosine-1-phosphate receptor (S1PR) modulator (eg, ozanimod or etrasimod). Note: Participants who have had an inadequate response to > 1 advanced therapy (eg, anti integrin, anti-IL 12/23, IL-23 p19 antibody, or S1PR modulator) are not eligible.\n- Participant may be receiving a therapeutic dosage of the following drugs: oral 5-aminosalicylic acid (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 or equivalent (≤ 20 mg/day) or budesonide (≤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. Participants who enter the OLE will be required to undergo corticosteroid tapering; 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"}

Exclusion criteria

• {"criterion_text":"- The following complications: acute severe ulcerative colitis, defined by ³ 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 £ 6 months) of toxic megacolon or bowel perforation\n- Diagnosis of Crohn’s disease (CD) or the presence or history of a fistula consistent with CD, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug induced colitis, idiopathic colitis (ie, colitis not consistent with UC), radiation colitis, microscopic colitis, infectious colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption\n- Participants who had an inadequate response to > 1 of the following treatments: vedolizumab, ustekinumab, anti-IL-23 p19 antibodies, or S1PR modulators for UC.\n- Participants who had an inadequate response or loss of response to TNF inhibitors or Janus kinase inhibitors."}

Primary endpoints

• {"endpoint_text":"- Incidence of adverse events (AEs), treatment emergent AEs (TEAEs), serious AEs, AEs of special interest, and treatment discontinuation due to TEAEs through Week 12","definition_or_measurement_approach":"Incidence measured through Week 12, capturing AEs, TEAEs, serious AEs, AEs of special interest, and treatment discontinuations attributable to TEAEs."}
• {"endpoint_text":"- Changes in clinical laboratory parameters, physical examination findings, and vital signs through Week 12","definition_or_measurement_approach":"Assessment of changes from baseline in laboratory parameters, physical examination findings, and vital signs up to Week 12."}
• {"endpoint_text":"- Proportion of participants achieving clinical remission, defined by a modified Mayo Score (mMS) ≤ 2 with a Mayo endoscopic subscore (MES) ≤ 1, rectal bleeding (RB) subscore of 0, and stool frequency (SF) subscore ≤ 1, at Week 12","definition_or_measurement_approach":"Clinical remission defined exactly as mMS ≤ 2 AND MES ≤ 1 AND RB subscore = 0 AND SF subscore ≤ 1; measured at Week 12."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants achieving endoscopic improvement, defined as an MES ≤ 1, at Week 12","definition_or_measurement_approach":"Endoscopic improvement defined as MES ≤ 1 measured at Week 12."}
• {"endpoint_text":"- Proportion of participants achieving endoscopic remission, defined as an MES = 0, at Week 12","definition_or_measurement_approach":"Endoscopic remission defined as MES = 0 measured at Week 12."}
• {"endpoint_text":"- Proportion of participants achieving mMS clinical response, defined as a reduction from Baseline ≥ 2 points and ≥ 30% in mMS, with a reduction ≥ 1 in RB subscore or absolute RB subscore ≤ 1, at Week 12","definition_or_measurement_approach":"mMS clinical response defined as reduction ≥2 points and ≥30% from baseline in mMS, plus either reduction ≥1 in RB subscore or absolute RB ≤1; measured at Week 12."}
• {"endpoint_text":"- Proportion of participants achieving symptomatic remission, defined as a SF subscore of 0 and an RB subscore of 0, at Week 12","definition_or_measurement_approach":"Symptomatic remission = SF subscore 0 AND RB subscore 0 at Week 12."}
• {"endpoint_text":"- Proportion of participants achieving histologic remission, defined as a Geboes Score  2B.0, at Week 12","definition_or_measurement_approach":"Histologic remission per Geboes Score ≤ 2B.0 at Week 12."}
• {"endpoint_text":"- Proportion of participants achieving histologic remission, defined as Robarts Histopathology Index ≤ 3 with subscores of 0 for lamina propria neutrophils, neutrophils in the epithelium, and erosions/ulcers, at Week 12","definition_or_measurement_approach":"Histologic remission per Robarts Histopathology Index ≤3 with specified subscores = 0 at Week 12."}
• {"endpoint_text":"- Proportion of participants achieving histologic endoscopic mucosal improvement, defined as a Geboes Score ≤ 3.1 and MES ≤ 1, at Week 12","definition_or_measurement_approach":"Combined histologic and endoscopic improvement: Geboes ≤3.1 AND MES ≤1 at Week 12."}
• {"endpoint_text":"- Proportion of participants achieving mucosal healing, defined as a Geboes Score ≤ 2B.1 and MES ≤ 1, at Week 12","definition_or_measurement_approach":"Mucosal healing defined as Geboes ≤2B.1 AND MES ≤1 at Week 12."}

Poland

Earliest CTIS Part Ii Submission Date

26-03-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

34

Number Of Sites

3

Number Of Participants

30

Primary sponsor

Full Name

Mage Biologics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Almac Clinical Services (Ireland) Limited

Responsibilities

IoR

Name

Alimentiv B.V.

Responsibilities

Clinical study management/site payments and other site management responsibilities

Name

Almac Group Limited

Responsibilities

Secondary packaging and distribution, EU QP release

Third parties

• {"country":"United States","full_name":"Acelabio (US) Inc.","duties_or_roles":"Specialty Lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Nespat Corp.","duties_or_roles":"Participant reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Tillotts Pharma AG","duties_or_roles":"Manufacturer bulk clinical trial medication","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"IoR","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"Secondary packaging and distribution, EU QP release","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Tillotts Pharma AG","duties_or_roles":"testing (except microbiological quality)","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Amsterdam UMC Research B.V.","duties_or_roles":"Specialty Lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Biovalorem LLC","duties_or_roles":"Quality Assurance, DPO","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Alimentiv B.V.","duties_or_roles":"site payments (other duties listed by internal codes in CTIS record)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"Central laboratory","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Specialty Lab","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Chimera Biotec GmbH","duties_or_roles":"PK and ADA analysis","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"SocraTec R&D Concepts in Drug Research and Development GmbH","duties_or_roles":"PK evaluation","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Eurofins BioPharma Product Testing Switzerland AG","duties_or_roles":"IP testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Switzerland","full_name":"SGS Analytics Switzerland AG","duties_or_roles":"IP testing","organisation_type":"Pharmaceutical company"}