Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Gastrointestinal, Stomach, Esophageal
Enrollment Eligibility
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.