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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the United States.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Landos Biopharma Inc.

Criteria

Key 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.

Key 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.