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New treatment option for Ulcerative Colitis (UC)
Official title A Study of MB-001 in Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07374471
What this study is testing
What is MB-001?
MB-001 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ulcerative colitis (uc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- 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...
- Demonstrated, in the opinion of the investigator, an inadequate response, loss of response, or intolerance/medical contraindication to at least 1 of...
- Oral 5-ASA compounds or sulfasalazine
You likely can't join 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 \>...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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)
- An approved S1PR modulator (eg, ozanimod or etrasimod) Note: Participants who have had an inadequate response to more than 1 advanced therapy (eg, anti-integrin, anti-IL 12/23, IL-23 p19 antibody, or S1PR modulator) are...
- 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...
- 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:
- Is eligible to participate if not pregnant or breastfeeding, and the following conditions apply:
- Of childbearing potential and using an acceptable contraceptive method during treatment with the IMP and for a minimum until 28 days after the last dose of IMP. The investigator should evaluate the potential or...
- Must have a negative highly sensitive pregnancy test as required by local regulations within 24 hours before the first dose of IMP,
- Must agree not to donate eggs (ova, oocytes) for the purpose of assisted reproduction during the study and for a period of 28 days after receiving the last dose of IMP.
- Able to participate fully in all aspects of this clinical trial. Full comprehension of consent language and informed consent must be obtained from the participant, or the participant's legally acceptable representative.
What rules you out
- 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 \ 30 mm/h, or C-reactive protein \> 30 mg/l, or in...
- 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...
- 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...
- 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...
- 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.
- Increased risk of infectious complications (eg, recent pyogenic infection, any congenital or acquired immunodeficiency [eg, HIV infection], or past organ or stem cell transplantation).
- Systemic or opportunistic infections:
- A positive diagnostic TB test at Screening (defined as a positive QuantiFERON(R) test). In cases where the QuantiFERON(R) test is indeterminate, the participant may have the test repeated once and if their second test...
- A positive test for HBV, as defined by the presence of HBsAg or HBcAb test. Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if no HBV DNA is present...
- A positive test for HCV, as defined by a positive HCVAb test and detectable HCV RNA. Note: Participants who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or...
- Evidence of Clostridioides difficile toxin or treatment for C. difficile infection, or other intestinal bacterial pathogen, within 4 weeks prior to Screening.
- Clinically active cytomegalovirus infection.
- Any other clinically significant extra-intestinal infection or opportunistic, chronic, or recurring infection within 6 months prior to randomization, including, but not limited to infections requiring IV antibiotics...
- History of opportunistic infections.
- Autoimmune disorders that may require treatment with immunosuppressant therapy.
- Any of the following laboratory abnormalities during the screening period. If values are initially outside the prescribed limits, the evaluation may be repeated once within the screening period to determine eligibility:
- Hemoglobin level: \< 8.0 g/dL
- Absolute white blood cell count: \< 3.0 x 109/L
- Absolute lymphocyte count: \< 0.5 x 109/L
- Absolute neutrophil count: \< 1.5 x 109/L
- Platelet count: \ 1200 x 109/L
- Alanine aminotransferase or aspartate aminotransferase: \> 2.5 x ULN
- Alkaline phosphatase: \> 2.5 x ULN
- Bilirubin: \> 1.5 x ULN
- 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 JAK inhibitors.
- Participants taking the following medical therapies for UC:
- Any biologic therapy (eg, anti-integrins, anti-ILs) within 8 weeks or 5 half-lives (whichever is longer) prior to randomization
- S1PR modulators within 4 weeks or 5 half-lives (whichever is longer) prior to randomization
- IV antibiotics within 8 weeks prior to randomization or expected to receive IV antibiotics during the conduct of the study
- Any rectal therapy for treatment of UC within 2 weeks prior to Screening endoscopy
- NSAIDs as long-term treatment, defined as use for at least 4 days a week each month (\> 100 mg daily or acetaminophen and aspirin \> 325 mg daily)
- Any medicinal product, herbal medication, or natural health product which might interfere with peristalsis within 2 weeks prior to randomization.
- Participants unwilling to withhold protocol-prohibited medications during the study.
- Fecal microbiota transplant (includes human microbiota-based therapeutics) within 4 weeks prior to randomization.
- Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination during conduct of the study.
- Any major surgery, in the investigator's opinion, performed within 8 weeks prior to randomization or planned during the study (ie, any surgical procedure requiring general anesthesia).
- Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.
- Prior enrolment in the current study and had received IMP.
- History of excessive alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
- Known or suspected allergy, hypersensitivity or intolerance to the IMP or its' excipients.
- Participant is performing mandatory military service, deprived of liberty, in a residential care institution, or due to a judicial decision cannot take part in a clinical study.
- Participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling).
- Participant has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, IMP administration, study participation, or may...
The study team makes the final eligibility decision.
Where it's taking place
- Chisinau, Moldova
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chisinau, Moldova. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.