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

Ulcerative Colitis Clinical Trial

Official title:

A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862741
• Other study ID #: NX-13-1b
• Status: Completed
• Phase: Phase 1
• Start date: May 5, 2021
• Est. completion date: October 5, 2022

Study information

• Verified date: February 2023
• Source: Landos Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 5, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Ukraine	Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont.	Dnipro
Ukraine	Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council	Ivano-Frankivs'k
Ukraine	Clinical Hospital "Feofaniya" of State Management of Affairs, Center of Gastroenterology and Endocrinology	Kyiv
Ukraine	Communal Non-commercial Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Department of Therapy	Kyiv
Ukraine	Medical Center 'Ok!Clinic+' of Copmany with limited liability "International institue of Clinical Research"	Kyiv
Ukraine	Communal Non-Commercial Enterprise of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council	Vinnytsia
Ukraine	Communal Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology	Vinnytsia
Ukraine	Medical Center of Limited Liability Company Gastroenterology Center IBD TEAM	Zaporizhzhya
Ukraine	Communal Non-commercial Enterprise O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council	Zhytomyr
United States	Avant Research Associates, LLC	Austin	Texas
United States	Galen Medical Group	Chattanooga	Tennessee
United States	Optimed Research, LTD	Columbus	Ohio
United States	Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia
United States	Biopharma Informatics, LLC	Houston	Texas
United States	Avant Research Associates LLC	Huntsville	Alabama
United States	I.H.S Health LLC	Kissimmee	Florida
United States	Om Research LLC	Lancaster	California
United States	Care Access	Lumberton	North Carolina
United States	University of Miami Crohn's and Colitis Center	Miami	Florida
United States	Valencia Medical and Research Center	Miami	Florida
United States	Allameh Medical Corporation	Mission Viejo	California
United States	Care Access	New York	New York
United States	California Medical Research Associates, Inc.	Northridge	California
United States	Care Access	Orlando	Florida
United States	LinQ Research, LLC	Pearland	Texas
United States	Gastroenterology Associates of Pensacola, P.A.	Pensacola	Florida
United States	Care Access	Pottsville	Pennsylvania
United States	Care Access Research, Salt Lake City	Salt Lake City	Utah
United States	Southern Star Research Institute, LLC	San Antonio	Texas
United States	Victoria Gastroenterology	Victoria	Texas
United States	Clinical Research of California	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Landos Biopharma Inc.

Countries where clinical trial is conducted

United States,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC)	Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13	63 days
Secondary	PK profile of NX-13 after multiple oral dose administration in subjects with active UC	NX-13 concentrations in plasma, colonic tissue biopsies, and feces	63 days
Secondary	PK Parameters - Time to maximum concentration (tmax);	NX-13 concentrations, time to maximum concentration	63 days
Secondary	PK Parameters- Maximum concentration (Cmax)	NX-13 concentrations, maximum concentration	63 days
Secondary	PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast);	NX-13 concentrations, area under the concentration-time curve from time 0 to last measurable	63 days
Secondary	PK Parameters-Terminal half-life (t1/2)	NX-13 terminal half-life PK	63 days
Secondary	PK Parameters- clearance (CL);	NX-13 clearance PK	63 days
Secondary	PK Parameters- Vz, apparent volume of distribution during terminal phase.	NX-13 - Vz, apparent volume of distribution during terminal phase.	63 days