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

NCT04862741 | Completed Phase 1 FDA Drug

• 1 other identifier: NX-13-1b
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 31

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• PK profile of NX-13 after multiple oral dose administration in subjects with active UC

  63 days

• PK Parameters - Time to maximum concentration (tmax);

  63 days

• PK Parameters- Maximum concentration (Cmax)

  63 days

• PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast);

  63 days

• PK Parameters-Terminal half-life (t1/2)

  63 days

Study Arms (4)

NX-13 250mg IR

EXPERIMENTAL

Oral

Drug: NX-13 250mg IR

NX-13 500mg IR

EXPERIMENTAL

Oral

Drug: NX-13 500mg IR

NX-13 500mg MR

EXPERIMENTAL

Oral

Drug: NX-13 500mg MR

Placebo

PLACEBO COMPARATOR

Oral

Drug: Placebo

Interventions

NX-13 250mg IR 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 250mg IR

NX-13 500mg IR 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

NX-13 500mg MR 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

Placebo 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• aminosalicylates must be stable for ≥ 1 month prior to randomization.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Landos Biopharma Inc.: lead

Study Sites (31)

Avant Research Associates LLC

Huntsville, Alabama, 35802, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

Allameh Medical Corporation

Mission Viejo, California, 92691, United States

Location

California Medical Research Associates, Inc.

Northridge, California, 91324, United States

Location

Clinical Research of California

Walnut Creek, California, 94598, United States

Location

I.H.S Health LLC

Kissimmee, Florida, 34741, United States

Location

University of Miami Crohn's and Colitis Center

Miami, Florida, 33136, United States

Location

Valencia Medical and Research Center

Miami, Florida, 33165, United States

Location

Care Access

Orlando, Florida, 32825, United States

Location

Gastroenterology Associates of Pensacola, P.A.

Pensacola, Florida, 32503, United States

Location

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, 30033, United States

Location

Care Access

New York, New York, 10065, United States

Location

Care Access

Lumberton, North Carolina, 28538, United States

Location

Optimed Research, LTD

Columbus, Ohio, 43235, United States

Location

Care Access

Pottsville, Pennsylvania, 17901, United States

Location

Galen Medical Group

Chattanooga, Tennessee, 37404, United States

Location

Avant Research Associates, LLC

Austin, Texas, 78742, United States

Location

Biopharma Informatics, LLC

Houston, Texas, 77084, United States

Location

LinQ Research, LLC

Pearland, Texas, 77584, United States

Location

Southern Star Research Institute, LLC

San Antonio, Texas, 78229, United States

Location

Victoria Gastroenterology

Victoria, Texas, 77904, United States

Location

Care Access Research, Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont.

Dnipro, 49005, Ukraine

Location

Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council

Ivano-Frankivsk, 76008, Ukraine

Location

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

Kyiv, 02091, Ukraine

Location

Clinical Hospital "Feofaniya" of State Management of Affairs, Center of Gastroenterology and Endocrinology

Kyiv, 03143, Ukraine

Location

Communal Non-commercial Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Department of Therapy

Kyiv, 04078, Ukraine

Location

Communal Non-Commercial Enterprise of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council

Vinnytsia, 21018, Ukraine

Location

Communal Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology

Vinnytsia, 21029, Ukraine

Location

Medical Center of Limited Liability Company Gastroenterology Center IBD TEAM

Zaporizhzhya, 69121, Ukraine

Location

Communal Non-commercial Enterprise O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council

Zhytomyr, 10002, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 37952114 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

NX-13

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Simon Lichtiger, MD

  Landos Biopharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: April 28, 2021
• Study Start: May 5, 2021
• Primary Completion: June 17, 2022
• Study Completion: October 5, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

UA (9); US (22)