Efficacy and safety of oral BT-11 in moderate to severe Crohn's disease

Phase 2

• Conditions: Crohn's Disease; Digestive System; Crohn Disease

• Registration Number: ISRCTN10684113
• Lead Sponsor: andos Biopharma, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-03
• Last Update Posted: 17 August 2021
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months
2. Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD scored =6 ( =4 for isolated ileitis) (centrally read)
3. Prior biologic must have stopped at least 8 weeks before study (or within 4 weeks prior to randomization, if no detectable drug levels by validated or commercial assay) and previous biologic treatment failure is limited to 1 class of biologic (if applicable)
4. 5 -aminosalicylates (max 4.8 g/day) and oral corticosteroids (max 20 mg/day prednisone or equivalent) must be stable for the duration of the 12-week induction period

Exclusion Criteria

1. Ulcerative colitis
2. Imminent risk of ileocolectomy, symptomatic bowel stricture, ostomy or ileoanal pouch, stenoses, or short gut syndrome
3. Recent (within 2 months) abscess, unless drained and treated at least 6 weeks before randomization
4. History of bowel resection or diversion within 3 months prior to screening
5. Use of apheresis =2 weeks prior to screening; treatment with an immunosuppressant within 25 days prior to randomization
6. Known current bacterial or parasitic pathogenic enteric infection, live virus vaccination within 12 weeks of screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical remission rate defined by a CDAI score of <150 measured at 12 weeks using patient records

Secondary Outcome Measures

Name	Time	Method
<br> 1. Clinical response measured by a CDAI reduction from baseline (=100 points or CDAI <150) at 12 weeks<br> 2. Endoscopic remission measured by SES-CD OF 0-2 or SES-CD =4, a =2-point improvement over baseline, and no sub-score >1 at 12 weeks<br> 3. Histologic remission measured by Geboes score <2B.1 (with absence of neutrophils in lamina propria) at 12 weeks<br> 4. Endoscopic response measured by SES-CD score (proportion of subjects achieving clinical remission defined as 50% reduction from baseline in SES-CD score at 12 weeks)<br>