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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: NX-13 250mg IR; Drug: NX-13 500mg IR; Drug: NX-13 500mg MR; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Ukraine
  • Dnipro, Ukraine, 49005
    • Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont.
  • Ivano-Frankivs'k, Ukraine, 76008
    • Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
  • Kyiv, Ukraine, 02091
    • Medical Center 'Ok!Clinic+' of Copmany with limited liability "International institue of Clinical Research"
  • Kyiv, Ukraine, 03143
    • Clinical Hospital "Feofaniya" of State Management of Affairs, Center of Gastroenterology and Endocrinology
  • Kyiv, Ukraine, 04078
    • Communal Non-commercial Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Department of Therapy
  • Vinnytsia, Ukraine, 21018
    • Communal Non-Commercial Enterprise of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council
  • Vinnytsia, Ukraine, 21029
    • Communal Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology
  • Zaporizhzhya, Ukraine, 69121
    • Medical Center of Limited Liability Company Gastroenterology Center IBD TEAM
  • Zhytomyr, Ukraine, 10002
    • Communal Non-commercial Enterprise O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • Avant Research Associates LLC
  • California
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • Mission Viejo, California, United States, 92691
      • Allameh Medical Corporation
    • Northridge, California, United States, 91324
      • California Medical Research Associates, Inc.
    • Walnut Creek, California, United States, 94598
      • Clinical Research of California
  • Florida
    • Kissimmee, Florida, United States, 34741
      • I.H.S Health LLC
    • Miami, Florida, United States, 33136
      • University of Miami Crohn's and Colitis Center
    • Miami, Florida, United States, 33165
      • Valencia Medical and Research Center
    • Orlando, Florida, United States, 32825
      • Care Access
    • Pensacola, Florida, United States, 32503
      • Gastroenterology Associates of Pensacola, P.A.
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta Center for Gastroenterology, P.C.
  • New York
    • New York, New York, United States, 10065
      • Care Access
  • North Carolina
    • Lumberton, North Carolina, United States, 28538
      • Care Access
  • Ohio
    • Columbus, Ohio, United States, 43235
      • Optimed Research, LTD
  • Pennsylvania
    • Pottsville, Pennsylvania, United States, 17901
      • Care Access
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Galen Medical Group
  • Texas
    • Austin, Texas, United States, 78742
      • Avant Research Associates, LLC
    • Houston, Texas, United States, 77084
      • Biopharma Informatics, LLC
    • Pearland, Texas, United States, 77584
      • LinQ Research, LLC
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute, LLC
    • Victoria, Texas, United States, 77904
      • Victoria Gastroenterology
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Care Access Research, Salt Lake City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Oral	Drug: 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.
Experimental: NX-13 250mg IR; Oral	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.
Experimental: NX-13 500mg IR; Oral	Drug: 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.
Experimental: NX-13 500mg MR; Oral	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
PK Parameters - Time to maximum concentration (tmax);	NX-13 concentrations, time to maximum concentration	63 days
PK Parameters- Maximum concentration (Cmax)	NX-13 concentrations, maximum concentration	63 days
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
PK Parameters-Terminal half-life (t1/2)	NX-13 terminal half-life PK	63 days
PK Parameters- clearance (CL);	NX-13 clearance PK	63 days
PK Parameters- Vz, apparent volume of distribution during terminal phase.	NX-13 - Vz, apparent volume of distribution during terminal phase.	63 days

Collaborators and Investigators

• Sponsor: Landos Biopharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: NX-13-1b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No