Clinical trial
A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Name
NX-13-1b
Description
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.
Trial arms
Trial start
2021-05-05
Estimated PCD
2022-06-17
Trial end
2022-10-05
Status
Completed
Phase
Early phase I
Treatment
NX-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.
Arms:
NX-13 250mg IR
NX-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.
Arms:
NX-13 500mg IR
NX-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.
Arms:
NX-13 500mg MR
Placebo
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.
Arms:
Placebo
Size
39
Primary endpoint
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC)
63 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 39, 'type': 'ACTUAL'}}
Updated at
2023-02-15
1 organization
2 products
1 indication
Organization
Landos BiopharmaProduct
NX-13Indication
ulcerative colitisProduct
Placebo