A Study to Test a New Drug in Adults With Moderate to Severe Ulcerative Colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Mage Biologics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

22 May 2026 → ongoing

Decision date (initial)

2026-04-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Mage Biologics Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the safety and tolerability of MB-001 in participants with moderately to severely active UC.
To evaluate the efficacy of MB-001 in participants with moderately to severely active UC.

Secondary objectives 1

1. To evaluate the efficacy of MB-001 on clinical, symptoms, endoscopic, and histologic outcomes in participants with moderately to severely active UC

Conditions and MedDRA coding

Ulcerative Colitis

Regulatory references

Scientific advice from competent authorities

Medicines Evaluation Board

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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
2. Moderately to severely active UC, defined as an mMS of 5 to 9, inclusive, with MES ≥ 2 and RB subscore ≥ 1
3. 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.
4. 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.
5. 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 4

1. 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
2. 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
3. Participants who had an inadequate response to > 1 of the following treatments: vedolizumab, ustekinumab, anti-IL-23 p19 antibodies, or S1PR modulators for UC.
4. Participants who had an inadequate response or loss of response to TNF inhibitors or Janus kinase inhibitors.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Incidence of adverse events (AEs), treatment emergent AEs (TEAEs), serious AEs, AEs of special interest, and treatment discontinuation due to TEAEs through Week 12
2. Changes in clinical laboratory parameters, physical examination findings, and vital signs through Week 12
3. 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

Secondary endpoints 8

1. Proportion of participants achieving endoscopic improvement, defined as an MES ≤ 1, at Week 12
2. Proportion of participants achieving endoscopic remission, defined as an MES = 0, at Week 12
3. 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
4. Proportion of participants achieving symptomatic remission, defined as a SF subscore of 0 and an RB subscore of 0, at Week 12
5. Proportion of participants achieving histologic remission, defined as a Geboes Score  2B.0, at Week 12
6. 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
7. Proportion of participants achieving histologic endoscopic mucosal improvement, defined as a Geboes Score ≤ 3.1 and MES ≤ 1, at Week 12
8. Proportion of participants achieving mucosal healing, defined as a Geboes Score ≤ 2B.1 and MES ≤ 1, at Week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mage Biologics Inc.

Sponsor organisation

Mage Biologics Inc.

Address

200 Continental Drive Suite 401

City

Newark

Postcode

19713-4337

Country

United States

Scientific contact point

Organisation

Mage Biologics Inc.

Contact name

Johannes Spleiss

Public contact point

Organisation

Mage Biologics Inc.

Contact name

Johannes Spleiss

Third parties 15

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications