Efficacy and safety of oral BT-11 in mild to moderate ulcerative colitis

Phase 2

• Conditions: lcerative colitis; Digestive System; Ulcerative colitis

• Registration Number: ISRCTN14296856
• Lead Sponsor: andos Biopharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Last Update Posted: 24 January 2022
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 195

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified