Ulcerative colitis Digestive System Ulcerative colitis
Conditions
Interventions
A total of 195 subjects with mild to moderate UC (total Mayo Score 4-10
MES 2:2) are planned to be enrolled into this study from approximately 46 centers in Europe and the United States. Eligible subjects will be randomized in a 1:1:1 ratio to receive BT-11 low- dose (500
Sponsors
Landos Biopharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 65 years, inclusive 2. Diagnosis of UC for at least 3 months before screening 3. Mild to moderate UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with an MES 2 (confirmed by the central reader) 4. If subjects have previously received biologic therapy for UC (i.e., tumor necrosis factor [TNF] antagonists, vedolizumab or ustekinumab), they must have a washout period of 8 weeks before randomization 5. If subjects are receiving the following UC treatments, they must be on a stable dose for at least I month before randomization: 5- aminosalicylates (5-ASAs), oral corticosteroids 6. If subjects are receiving bile-salt sequestrant, they must be on a stable dose for at least 3 months before randomization 7. If subjects are receiving any non-prohibited medications, they must agree to maintain stable doses of concomitant medication s for UC for the duration of the trial 8. Unlikely to conceive, as defined by 1 of the following: (a) subject is surgically sterilized female, (b) subject is postmenopausal female 2: 45 years of age with clinical documentation of menopause (i.e., 12 months without menses), or c) matter is male or subject is woman of childbearing potential (WOCBP), and agrees to abstain from heterosexual activity, use adequate hormonal contraception, or use double barrier contraception 9. For WOCBP, the subject must have a negative pregnancy test at screening and within 24 hours before the first dose of study drug. 10. Able to participate fully in all aspects of this clinical trial 11. Written informed consent must be obtained and documented
Exclusion criteria
Exclusion criteria: 1. A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD 2. Severe UC as per modified Truelove and Witts criteria 3. Disease activity limited to the distal 15 cm (proctitis) 4. Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine [6-MP]) within 25 days before randomization 5. History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; history or is at imminent risk of colectomy 6. History or current evidence of colonic dysplasia or adenomatous colonic polyps 7. Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile, known infection with hepatitis B or C virus, known infection with human immunodeficiency virus, infection requiring hospitalization or intravenous s antimicrobial therapy, or opportunistic infection within 6 months prior to screening, any infection requiring antimicrobial therapy within 2 weeks prior to screening, history of more than 1 episode of herpes zoster or any episode of disseminated zoster 8. Live virus vaccination within 1 month prior to screening 9. Treatment with cyclosporine, mycophenolate, tacrolimus, or tofacitinib within 4 weeks prior to randomization 10. Treatment with intravenous corticosteroids, rectal corticosteroids, or rectal 5-ASA within 2 weeks before randomization 11. Fecal microbiota transplantation within 1 month prior to screening 12. A concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, Gl, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results or poses additional risk to the subject 13. Known primary or secondary immunodeficiency 14. History of myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure requiring hospitalization, congestive heart failure (New York Health Association [NYHA] Class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of screening 15. Laboratory abnormalities at screening, as determined and documented by the investigator 16. Pregnant or lactating females 17. Any surgical procedure anesthesia within I month prior to screening, or planned elective surgery during the study 18. History of malignant neoplasms or carcinoma in situ within 5 years prior to screening 19. Current or recent history of alcohol dependence or illicit drug use that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures 20. Mental or legal incapacitation at the time of screening visit or a history of clinically significant psychiatric disorders that would impact the ability to participate in the trial according to the investigator 21. Unable to attend study visits or comply with procedures 22. Concurrent participation in any other interventional study 23. Received any investigational therapy within 30 days of initiation of study drug 24. Underlying severe dise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate at Week 12 as defined by total Mayo score less than or equal to 2 with all sub-scores less than or equal to 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Endoscopic remission rate at Week 12 (Mayo endoscopic sub-score [MES] of 0 or 1) 2. Mucosal healing rate at Week 12 as defined by an MES of 0 or 1 and a Geboes Histologic Index score of less than 3 3. Mean change in fecal calprotectin measured by enzyme-linked immunosorbent assay (ELISA) from baseline to Weeks 2, 6, and 12 4. Concentration of BT-11 in feces measured by high-performance liquid chromatography (HPLC) assay at Weeks 2, 6, and 12 5. Number of participants with treatment-related adverse events at Week 12 | — |
Countries
Belarus, Bosnia and Herzegovina, Croatia, Georgia, Hungary, Moldova, Poland, Russian Federation, Serbia, Ukraine, United States of America
Outcome results
None listed