Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Lead Sponsor:
Landos Biopharma Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 r...
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. E...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04862741
Start Date
May 5 2021
End Date
October 5 2022
Last Update
February 15 2023
Active Locations (31)
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1
Avant Research Associates LLC
Huntsville, Alabama, United States, 35802
2
Om Research LLC
Lancaster, California, United States, 93534
3
Allameh Medical Corporation
Mission Viejo, California, United States, 92691
4
California Medical Research Associates, Inc.
Northridge, California, United States, 91324