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

Sponsor
Landos Biopharma Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04862741
Collaborator
(none)
40
Enrollment
31
Locations
4
Arms
13.9
Anticipated Duration (Months)
1.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NX-13 250mg IR
  • Drug: NX-13 500mg IR
  • Drug: NX-13 500mg MR
  • Drug: Placebo
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Actual Study Start Date :
May 5, 2021
Actual Primary Completion Date :
Jun 17, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC) [63 days]

Secondary Outcome Measures

  1. PK profile of NX-13 after multiple oral dose administration in subjects with active UC [63 days]

    - NX-13 concentrations in plasma, colonic tissue biopsies, and feces

  2. PK Parameters - Time to maximum concentration (tmax); [63 days]

  3. PK Parameters- Maximum concentration (Cmax) [63 days]

  4. PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast); [63 days]

  5. PK Parameters-Terminal half-life (t1/2) [63 days]

  6. PK Parameters- clearance (CL); [63 days]

  7. PK Parameters- Vz, apparent volume of distribution during terminal phase. [63 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Clinical Research of California Walnut Creek California United States 94598
6 I.H.S Health LLC Kissimmee Florida United States 34741
7 University of Miami Crohn's and Colitis Center Miami Florida United States 33136
8 Valencia Medical and Research Center Miami Florida United States 33165
9 Care Access Orlando Florida United States 32825
10 Gastroenterology Associates of Pensacola, P.A. Pensacola Florida United States 32503
11 Atlanta Center for Gastroenterology, P.C. Decatur Georgia United States 30033
12 Care Access New York New York United States 10065
13 Care Access Lumberton North Carolina United States 28538
14 Optimed Research, LTD Columbus Ohio United States 43235
15 Care Access Pottsville Pennsylvania United States 17901
16 Galen Medical Group Chattanooga Tennessee United States 37404
17 Avant Research Associates, LLC Austin Texas United States 78742
18 Biopharma Informatics, LLC Houston Texas United States 77084
19 LinQ Research, LLC Pearland Texas United States 77584
20 Southern Star Research Institute, LLC San Antonio Texas United States 78229
21 Victoria Gastroenterology Victoria Texas United States 77904
22 Care Access Research, Salt Lake City Salt Lake City Utah United States 84124
23 Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont. Dnipro Ukraine 49005
24 Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council Ivano-Frankivs'k Ukraine 76008
25 Medical Center 'Ok!Clinic+' of Copmany with limited liability "International institue of Clinical Research" Kyiv Ukraine 02091
26 Clinical Hospital "Feofaniya" of State Management of Affairs, Center of Gastroenterology and Endocrinology Kyiv Ukraine 03143
27 Communal Non-commercial Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Department of Therapy Kyiv Ukraine 04078
28 Communal Non-Commercial Enterprise of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council Vinnytsia Ukraine 21018
29 Communal Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology Vinnytsia Ukraine 21029
30 Medical Center of Limited Liability Company Gastroenterology Center IBD TEAM Zaporizhzhya Ukraine 69121
31 Communal Non-commercial Enterprise O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council Zhytomyr Ukraine 10002

Sponsors and Collaborators

  • Landos Biopharma Inc.

Investigators

  • Study Director: Simon Lichtiger, MD, Landos Biopharma Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Landos Biopharma Inc.
ClinicalTrials.gov Identifier:
NCT04862741
Other Study ID Numbers:
  • NX-13-1b
First Posted:
Apr 28, 2021
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer

Study Results

No Results Posted as of Jul 1, 2022