Ulcerative Colitis
Conditions
Brief 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.
Detailed 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).
Interventions
DRUGNX-13 250mg IR
Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
DRUGNX-13 500mg IR
Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
DRUGNX-13 500mg MR
Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
DRUGPlacebo
Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
Sponsors
Landos Biopharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC) | 63 days | Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameters - Time to maximum concentration (tmax); | 63 days | NX-13 concentrations, time to maximum concentration |
| PK Parameters- Maximum concentration (Cmax) | 63 days | NX-13 concentrations, maximum concentration |
| PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast); | 63 days | NX-13 concentrations, area under the concentration-time curve from time 0 to last measurable |
| PK profile of NX-13 after multiple oral dose administration in subjects with active UC | 63 days | NX-13 concentrations in plasma, colonic tissue biopsies, and feces |
| PK Parameters- clearance (CL); | 63 days | NX-13 clearance PK |
| PK Parameters- Vz, apparent volume of distribution during terminal phase. | 63 days | NX-13 - Vz, apparent volume of distribution during terminal phase. |
| PK Parameters-Terminal half-life (t1/2) | 63 days | NX-13 terminal half-life PK |
Countries
Ukraine, United States
Outcome results
None listed