2025-524719-35-00
Recruiting
Phase 2
A Phase 1b/2a, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MB-001 in Participants With Moderately to Severely Active Ulcerative Colitis
Mage Biologics Inc.0 sites30 target enrollmentStarted: March 31, 2026Last updated:
ConditionsUlcerative Colitis
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Mage Biologics Inc.
- Enrollment
- 30
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Moderately to severely active UC, defined as an mMS of 5 to 9, inclusive, with MES ≥ 2 and RB subscore ≥ 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-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.
- •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
- •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
- •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
- •Participants who had an inadequate response to > 1 of the following treatments: vedolizumab, ustekinumab, anti-IL-23 p19 antibodies, or S1PR modulators for UC.
- •Participants who had an inadequate response or loss of response to TNF inhibitors or Janus kinase inhibitors.
Investigators
Johannes Spleiss
Scientific
Mage Biologics Inc.
Similar Trials
Not yet recruiting
Not Applicable
MHB018A Treatment in Patients With Chronic Thyroid Eye DiseaseNCT07257185Minghui Pharmaceutical (Hangzhou) Ltd150
Recruiting
Phase 2
A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS) (FUSION)2022-502552-31-00Biogen Idec Research Limited195
Active, not recruiting
Phase 3
An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis2022-502361-15-00Bristol Myers Squibb International Corporation664
Recruiting
Phase 1
A Study of MB-001 in Moderately to Severely Active Ulcerative ColitisNCT07374471Mage Biologics100
Recruiting
Phase 2
Study to Assess Efficacy and Safety of Tozorakimab in Adults with Uncontrolled Asthma on Medium-to-High Dose Inhaled CorticosteroidsCTRI/2025/08/092776AstraZeneca AB540