Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Landos Biopharma Inc.

Criteria

Key Inclusion Criteria:

• male and female subjects aged 18 to 75 years (inclusive) with a diagnosis of UC ≥ 90 days before screening;

• active UC defined as a total Mayo Score of 4 to 10 (inclusive), at baseline, with a Mayo endoscopic subscore (MES) ≥ 2 confirmed by a central reader;

• baseline fecal calprotectin ≥ 250 μg/g;

• biologic-naïve or having stopped biologic therapy ≥ 8 weeks before the start of the study;

• 5-aminosalicylates must be stable for ≥ 1 month prior to randomization.

Key Exclusion Criteria:

• Crohn's disease (CD), indeterminate colitis, or presence or history of fistula with CD;

• a history of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma;

• history of or at imminent risk of colectomy;

• history of or current colonic dysplasia ;

• recent history (within 2 years prior to randomization) or current adenomatous colonic polyps;

• treatment with an immunosuppressant within 3 months of randomization;

• bacterial or parasitic pathogenic enteric infection;

• live virus vaccination within 1 month prior to screening.