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

Launched by LANDOS BIOPHARMA INC. · Apr 23, 2021

Keywords

ClinConnect Summary

Following screening period (up to 28 days in length), a total of 40 subjects are planned to be enrolled into this study from multiple sites in the United States, Australia, New Zealand, and Moldova. Eligible 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) or placebo via a computer-generated interactive web response system (IWRS). Each of the NX-13 treatment groups will comprise 12 subjects and 4 subjects will be randomized to receive placebo. The study will include a maximum of 25% of subjects who have had pri...

Gender

ALL

Eligibility 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.