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

NCT ID: NCT04862741

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2022-10-05

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).

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NX-13 250mg IR

Oral

Group Type: EXPERIMENTAL

NX-13 250mg IR

Intervention Type: DRUG

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

Oral

Group Type: EXPERIMENTAL

NX-13 500mg IR

Intervention Type: DRUG

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

Oral

Group Type: EXPERIMENTAL

NX-13 500mg MR

Intervention Type: DRUG

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

Oral

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Landos Biopharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Lichtiger, MD

Role: STUDY_DIRECTOR

Landos Biopharma Inc.

Locations

Avant Research Associates LLC

Huntsville, Alabama, United States

Om Research LLC

Lancaster, California, United States

Allameh Medical Corporation

Mission Viejo, California, United States

California Medical Research Associates, Inc.

Northridge, California, United States

Clinical Research of California

Walnut Creek, California, United States

I.H.S Health LLC

Kissimmee, Florida, United States

University of Miami Crohn's and Colitis Center

Miami, Florida, United States

Valencia Medical and Research Center

Miami, Florida, United States

Care Access

Orlando, Florida, United States

Gastroenterology Associates of Pensacola, P.A.

Pensacola, Florida, United States

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, United States

Care Access

New York, New York, United States

Care Access

Lumberton, North Carolina, United States

Optimed Research, LTD

Columbus, Ohio, United States

Care Access

Pottsville, Pennsylvania, United States

Galen Medical Group

Chattanooga, Tennessee, United States

Avant Research Associates, LLC

Austin, Texas, United States

Biopharma Informatics, LLC

Houston, Texas, United States

LinQ Research, LLC

Pearland, Texas, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

Victoria Gastroenterology

Victoria, Texas, United States

Care Access Research, Salt Lake City

Salt Lake City, Utah, United States

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-Frankivsk, , Ukraine

Medical Center 'Ok!Clinic+' of Copmany with limited liability "International institue of Clinical Research"

Kyiv, , 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

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, , Ukraine

Countries

United States; Ukraine

References

Verstockt B, Vermeire S, Peyrin-Biroulet L, Mosig R, Feagan BG, Colombel JF, Siegmund B, Rieder F, Schreiber S, Yarur A, Panaccione R, Dubinsky M, Lichtiger S, Cataldi F, Danese S. The Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study. J Crohns Colitis. 2024 May 31;18(5):762-772. doi: 10.1093/ecco-jcc/jjad192.

Reference Type: DERIVED

PMID: 37952114 (View on PubMed)

Other Identifiers

NX-13-1b

Identifier Type: -

Identifier Source: org_study_id