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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NX-13 250mg IR
NX-13 500mg IR
NX-13 500mg MR
Placebo
Sponsored by
Landos Biopharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Avant Research Associates LLC
  • Om Research LLC
  • Allameh Medical Corporation
  • California Medical Research Associates, Inc.
  • Clinical Research of California
  • I.H.S Health LLC
  • University of Miami Crohn's and Colitis Center
  • Valencia Medical and Research Center
  • Care Access
  • Gastroenterology Associates of Pensacola, P.A.
  • Atlanta Center for Gastroenterology, P.C.
  • Care Access
  • Care Access
  • Optimed Research, LTD
  • Care Access
  • Galen Medical Group
  • Avant Research Associates, LLC
  • Biopharma Informatics, LLC
  • LinQ Research, LLC
  • Southern Star Research Institute, LLC
  • Victoria Gastroenterology
  • Care Access Research, Salt Lake City
  • Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont.
  • Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
  • Medical Center 'Ok!Clinic+' of Copmany with limited liability "International institue of Clinical Research"
  • Clinical Hospital "Feofaniya" of State Management of Affairs, Center of Gastroenterology and Endocrinology
  • Communal Non-commercial Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Department of Therapy
  • Communal Non-Commercial Enterprise of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council
  • Communal Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology
  • Medical Center of Limited Liability Company Gastroenterology Center IBD TEAM
  • Communal Non-commercial Enterprise O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

NX-13 250mg IR

NX-13 500mg IR

NX-13 500mg MR

Placebo

Arm Description

Oral

Oral

Oral

Oral

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2021
Last Updated
February 13, 2023
Sponsor
Landos Biopharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04862741
Brief Title
Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Official Title
A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Landos Biopharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NX-13 250mg IR
Arm Type
Experimental
Arm Description
Oral
Arm Title
NX-13 500mg IR
Arm Type
Experimental
Arm Description
Oral
Arm Title
NX-13 500mg MR
Arm Type
Experimental
Arm Description
Oral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral
Intervention Type
Drug
Intervention Name(s)
NX-13 250mg IR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NX-13 500mg IR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NX-13 500mg MR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC)
Description
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13
Time Frame
63 days
Secondary Outcome Measure Information:
Title
PK profile of NX-13 after multiple oral dose administration in subjects with active UC
Description
NX-13 concentrations in plasma, colonic tissue biopsies, and feces
Time Frame
63 days
Title
PK Parameters - Time to maximum concentration (tmax);
Description
NX-13 concentrations, time to maximum concentration
Time Frame
63 days
Title
PK Parameters- Maximum concentration (Cmax)
Description
NX-13 concentrations, maximum concentration
Time Frame
63 days
Title
PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast);
Description
NX-13 concentrations, area under the concentration-time curve from time 0 to last measurable
Time Frame
63 days
Title
PK Parameters-Terminal half-life (t1/2)
Description
NX-13 terminal half-life PK
Time Frame
63 days
Title
PK Parameters- clearance (CL);
Description
NX-13 clearance PK
Time Frame
63 days
Title
PK Parameters- Vz, apparent volume of distribution during terminal phase.
Description
NX-13 - Vz, apparent volume of distribution during terminal phase.
Time Frame
63 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Lichtiger, MD
Organizational Affiliation
Landos Biopharma Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Avant Research Associates LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Allameh Medical Corporation
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
California Medical Research Associates, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Clinical Research of California
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
I.H.S Health LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
University of Miami Crohn's and Colitis Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Valencia Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Care Access
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Gastroenterology Associates of Pensacola, P.A.
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Atlanta Center for Gastroenterology, P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Care Access
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Care Access
City
Lumberton
State/Province
North Carolina
ZIP/Postal Code
28538
Country
United States
Facility Name
Optimed Research, LTD
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Care Access
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Facility Name
Galen Medical Group
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Avant Research Associates, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78742
Country
United States
Facility Name
Biopharma Informatics, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
LinQ Research, LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Southern Star Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Victoria Gastroenterology
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
Care Access Research, Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont.
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
City
Ivano-Frankivs'k
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Medical Center 'Ok!Clinic+' of Copmany with limited liability "International institue of Clinical Research"
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Clinical Hospital "Feofaniya" of State Management of Affairs, Center of Gastroenterology and Endocrinology
City
Kyiv
ZIP/Postal Code
03143
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Department of Therapy
City
Kyiv
ZIP/Postal Code
04078
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprise of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company Gastroenterology Center IBD TEAM
City
Zaporizhzhya
ZIP/Postal Code
69121
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

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

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