Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: NX-13 250mg IRDrug: NX-13 500mg IRDrug: NX-13 500mg MRDrug: Placebo
- Registration Number
- NCT04862741
- Lead Sponsor
- Landos Biopharma Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NX-13 250mg IR NX-13 250mg IR Oral NX-13 500mg IR NX-13 500mg IR Oral NX-13 500mg MR NX-13 500mg MR Oral Placebo Placebo Oral
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC) 63 days Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13
- Secondary Outcome Measures
Name Time Method 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
PK Parameters - Time to maximum concentration (tmax); 63 days NX-13 concentrations, time to maximum concentration
PK Parameters- Maximum concentration (Cmax) 63 days NX-13 concentrations, maximum concentration
PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast); 63 days NX-13 concentrations, area under the concentration-time curve from time 0 to last measurable
PK Parameters-Terminal half-life (t1/2) 63 days NX-13 terminal half-life PK
PK Parameters- clearance (CL); 63 days NX-13 clearance PK
PK Parameters- Vz, apparent volume of distribution during terminal phase. 63 days NX-13 - Vz, apparent volume of distribution during terminal phase.
Trial Locations
- Locations (28)
Allameh Medical Corporation
🇺🇸Mission Viejo, California, United States
Avant Research Associates, LLC
🇺🇸Austin, Texas, United States
Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont.
🇺🇦Dnipro, Ukraine
Care Access
🇺🇸Pottsville, Pennsylvania, United States
Clinical Hospital "Feofaniya" of State Management of Affairs, Center of Gastroenterology and Endocrinology
🇺🇦Kyiv, Ukraine
Medical Center 'Ok!Clinic+' of Copmany with limited liability "International institue of Clinical Research"
🇺🇦Kyiv, Ukraine
Communal Non-Commercial Enterprise of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council
🇺🇦Vinnytsia, Ukraine
Om Research LLC
🇺🇸Lancaster, California, United States
I.H.S Health LLC
🇺🇸Kissimmee, Florida, United States
Optimed Research, LTD
🇺🇸Columbus, Ohio, United States
Galen Medical Group
🇺🇸Chattanooga, Tennessee, United States
Biopharma Informatics, LLC
🇺🇸Houston, Texas, United States
University of Miami Crohn's and Colitis Center
🇺🇸Miami, Florida, United States
Valencia Medical and Research Center
🇺🇸Miami, Florida, United States
Avant Research Associates LLC
🇺🇸Huntsville, Alabama, United States
Clinical Research of California
🇺🇸Walnut Creek, California, United States
Gastroenterology Associates of Pensacola, P.A.
🇺🇸Pensacola, Florida, United States
Atlanta Center for Gastroenterology, P.C.
🇺🇸Decatur, Georgia, United States
California Medical Research Associates, Inc.
🇺🇸Northridge, California, United States
Victoria Gastroenterology
🇺🇸Victoria, Texas, United States
LinQ Research, LLC
🇺🇸Pearland, Texas, United States
Care Access Research, Salt Lake City
🇺🇸Salt Lake City, Utah, United States
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
Southern Star Research Institute, LLC
🇺🇸San Antonio, Texas, United States
Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
🇺🇦Ivano-Frankivs'k, Ukraine
Communal Non-commercial Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Department of Therapy
🇺🇦Kyiv, Ukraine
Communal Non-commercial Enterprise O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council
🇺🇦Zhytomyr, Ukraine