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

Landos Biopharma

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: NX-13 250mg IR; Drug: NX-13 500mg MR; Drug: NX-13 500mg IR; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04862741

NX-13-1b

Details and patient eligibility

About

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.

Full description

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 prior exposure to biologic therapy for UC.

Dosing will extend over a 28-day period at each dose level. Subjects will receive the first dose of study drug in clinic on Day 1 (Visit 2) and Day 28 (Visit 4/EOT) but will self-administer IP at home once daily for the remaining dosing days. The study duration will be approximately 63 days: Screening Period (28 days) + Treatment Period (28 days) + Safety Follow-up (7 days after last dose). There will be a follow-up visit on Day 35 (Visit 5).

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 4 patient groups, including a placebo group

NX-13 250mg IR

Experimental group

Description:

Oral

Treatment:

Drug: NX-13 250mg IR

NX-13 500mg IR

Experimental group

Description:

Oral

Treatment:

Drug: NX-13 500mg IR

NX-13 500mg MR

Experimental group

Description:

Oral

Treatment:

Drug: NX-13 500mg MR

Placebo

Placebo Comparator group

Description:

Oral

Treatment:

Drug: Placebo