Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

This is an interventional treatment trial for Crohn's Disease Read More

Inclusion Criteria:

1. Male and female subjects age 18 to 75 years, inclusive.
2. Diagnosis of CD for at least 6 weeks prior to screening
3. A history of right colonic and/or distal ileal CD confirmed by ileo-colonoscopy, magnetic resonance imaging (MRI) or computed tomograph (CT)

4. Moderate to severely active CD as defined by all of the following:

   • CDAI score of 220-450
   • PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
   • SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader
5. If participants have previously received TNF antagonist therapy, ustekinumab, or vedolizumab, they must have washout period of 8 weeks or (5 half-lives, whichever is longer) prior to randomization.
6. If participants are receiving the following CD treatments, they must be receiving a stable dose for at least one month prior to randomization: 5-ASAs (not exceeding 4.8 g/day) or corticosteroids (not exceeding 20 mg prednisone or equivalent)
7. If participants are receiving any non-prohibited CD medications, they agree to maintain stable doses of concomitant medications for CD for the duration of the trial.

8. Participant is unlikely to conceive, as defined by one of the following:

   1. participant is surgically sterilized female,
   2. subject is post-menopausal female ≥ 45 years of age with clinical documentation of menopause, or
   3. subject is male or subject is woman of child bearing potential (WOCBP), and agrees to abstain from heterosexual activity, use adequate hormonal contraception or use double barrier contraception.
9. For WOCBP, participant must have a negative pregnancy test at screening and within 24 hours prior to first dose of study medication
10. Participant is able and willing to participate and be fully compliant to all aspects of this clinical trial.
11. Written informed consent must be obtained and documented

Exclusion Criteria:

1. Participant has ulcerative colitis
2. Participant is at imminent risk of ileo-colectomy
3. Participant has known or suspected strictures, stenoses, short gut syndrome or any other manifestation that precludes or confounds the assessment of response to therapy (CDAI and endoscopic evaluation)
4. Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to randomisation and are not anticipated to require surgery. Subjects with active fistulas may be included provided there is no anticipated need for surgery and there are currently no abscesses present.
5. Any history of bowel resection or diversion within 6 months prior to screening,

6. Adalimumab treatment with:

   • Total parenteral nutrition within 2 weeks of screening
   • TNF antagonist therapy or approved biologic (e.g., infliximab, Adalimumab, vedolizumab, certolizumab, ustekinumab, natalizumab) ≤8 weeks (or 5 half-lives, whichever is longer) prior to the first administration of study medication (or ≤ 4 weeks prior to randomization, if no detectable drug levels)
   • Approved nonbiologic therapies for CD (e.g., cyclosporine, mycophenolate, tacrolimus, tofacitinib, sirolimus) within 4 weeks prior to randomization.
   • Natalizumab, efalizumab, or agents that deplete B or T cells (e.g. rituximab, alemtuzumab, or visilizumab) within 6 months of screening, or if after receiving these agents evidence is available at screening of persistent depletion of the targeted lymphocyte population
   • Any investigational drug within the previous 30 days or 5 times the half-life of the investigational agent prior to randomization, whichever is longer
   • Regular daily use of opioids for medical or non-medical reasons within 3 months prior to randomization
   • Rectal 5-ASA compounds, parenteral or rectal corticosteroids within 4 weeks prior to randomization
   • Oral corticosteroids prednisone equivalent dose > 20 mg/day, or > 6 mg/day of budesonide, or any changes to dose within the 4 weeks prior to randomization.
   • Oral immunosuppressants (methotrexate, azathioprine, 6-MP) within 4 weeks prior to randomization.
   • Antibiotics for CD within 4 weeks prior to screening
7. Use of apheresis (e.g., Adacolumn apheresis) ≤2 weeks prior to screening.
8. Any live bacterial or viral vaccination ≤12 weeks prior to randomization. Patients must agree not to receive a live virus or bacterial vaccination during the study or up to 12 months after the last administration of study drug.
9. Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
10. Current signs or symptoms of infection, including any infection requiring hospitalization, IV antibiotics, or draining, for 2 months prior to screening
11. History of chronic or recurrent infection
12. Evidence of active herpes zoster infection ≤8 weeks of screening
13. Stool culture or other examination positive for an enteric pathogen, including Clostridium (Clostridioides) difficile toxin, in the past 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
14. History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
15. Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
16. Established non-serious infections (e.g. acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator.
17. Recent history (≤ 2 years) or current evidence of colonic dysplasia or adenomatous colonic polyps
18. Participant has a concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, 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 participant
19. History of myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure requiring hospitalization, congestive heart failure (NYHA Class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of screening
20. Clinically meaningful laboratory abnormalities at screening suggestive of underlying liver abnormalities, cardiovascular abnormalities or infection.
21. Pregnant or lactating females
22. Any surgical procedure requiring general anesthesia within one month prior to screening, or planned elective surgery during the study
23. History of malignant neoplasms or carcinoma in situ within 5 years prior to screening

24. Current or recent history of alcohol dependence or illicit drug use that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures.

    Participant is mentally or legally incapacitated at the time of screening visit or has a history of clinically significant psychiatric disorders that would impact the participant's ability to participate in the trial according to the investigator

25. Unable to attend study visits or comply with procedures
26. Concurrent participation in any other interventional study.
27. Patient has been previously exposed to omilancor (BT-11).
28. History of sensitivity to any of the study treatments (omilancor, adalimumab) or any component.
29. Prior enrolment in the current study and had received study treatment.