Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study With Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants w/ Moderate to Severe Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785715
• Other study ID #: NX-13-201
• Status: Recruiting
• Phase: Phase 2
• Start date: April 24, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Landos Biopharma Inc.
• Contact: Claudia Lopez, DVM
• Phone: 540-218-2232
• Email: clinicaloperations[@]landosbiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

Description:

This is a randomized, multicenter, double-blind, placebo-controlled, multiple dose exploratory Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult subjects aged 18 to 75 years (inclusive)
• Diagnosis of UC = 90 days before screening confirmed by histologic evidence
• Active UC defined as a total Mayo Score (MMS) of = 5 (inclusive) at baseline
• ES = 2 within 14 days prior to randomization
• RBS = 1.

Exclusion Criteria:

• Severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization;
• Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation
• Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD
• Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis
• Bacterial or parasitic pathogenic enteric infection;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• NX-13 250mg
NX-13 250mg tablet, plus 2 placebo tablets
• NX-13 750mg
NX-13 250mg tablets times 3 to equal 750mg
• NX-13 Placebo
NX-13 Placebo tablets times 3 for blinding purposes

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven
Italy	Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele	Milan
Italy	Azienda Ospedaliera - Universitaria Sant' Andrea	Roma
Italy	Azienda Ospedaliera San Camillo Forlanini	Rome
Italy	Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas	Rozzano
Italy	IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo	San Giovanni Rotondo
Italy	Azienda Ospedaliera Ordine Mauriziano di Torino	Torino
Poland	ClinSante - Osrodek Badan Klinicznych w Bydgoszczy	Bydgoszcz
Poland	Przychodnia Vitamed NFZ	Bydgoszcz
Poland	VITA LONGA Clinic - Katowice	Katowice
Poland	Krakowska Przychodnia FutureMeds	Kraków
Poland	Uniwersytet Medyczny w Lodzi	Lodz
Poland	RiverMED Poradnie Specjalistyczne Poznan	Poznan
Poland	Twoja Przychodnia Opolskie Centrum Medyczne	Poznan
Poland	Centrum Medyczne SOPMED	Sopot
Poland	Niepubliczny Zaklad Opieki Zdrowotnej SONOMED	Szczecin
Poland	Twoja Przychodnia Szczecinskie Centrum Medyczne	Szczecin
Poland	Torunskiego Centrum Gastrologii I Endoskopii - Gastromed	Torun
Poland	H-T Centrum Medyczne	Tychy
Poland	Office of Jaroslaw Kierkus, Dr N Med	Warszawa
Poland	Centrum Diagnostyczno - Lecznicze Barska	Wloclawek
Poland	Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.	Wroclaw
Poland	Zabobrze Centrum Medyczne	Wroclaw
United States	Digestive Health Center of Michigan	Chesterfield	Michigan
United States	GI Alliance Research - Garland	Garland	Texas
United States	GI Alliance - Texas Digestive Disease Consultants	Mansfield	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
United States	Orlando Health, Inc.	Orlando	Florida
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	GI Alliance Research	Southlake	Texas
United States	GCP Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Landos Biopharma Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the clinical activity of oral NX-13 vs placebo	Change from baseline in mean Modified Mayo Score (MMS) vs placebo. Total score Modified Mayo score 0-9, with higher scores representing more severe disease activity.	365 days
Secondary	Safety and Tolerability-AE/SAE - Hematology	Treatment Emergent Adverse Event/Serious Adverse Event (TEAEs/SAEs) related to hematology. Assessment will be made by summarizing the percentage of subjects with changes from baseline through routine hematology panel (white blood cells, red blood cells, Hemoglobin, Hematocrit, and platelets). All biomarkers are exploratory objectives.	365 days
Secondary	Safety and Tolerability-AE/SAE - Chemistry	Treatment Emergent Adverse Event/Serious Adverse Event (TEAEs/SAEs) related to chemistry. Assessment will be made by summarizing the percentage of subjects with changes from baseline through routine chemistry panel (Blood Urea Nitrogren creatinine, Creatine Kinase bilirubin, Aspartate aminotransferase (AST), Alanine transaminase (ALT), Alkaline phosphatase (ALP), Sodium (Na), Potassium (K), Chloride (CL), bicarb, Calcium (CA), Magnesium (MG), Phosphorus, uric acid, total protein, albumin, glucose, Gamma-glutamyl transferase (GGT), total cholesterol, Low-density lipoprotein (LDL), High-density lipoprotein (HDL), and triglycerides) urinalysis, Estimated Glomerular filtration rate (eGFR). All biomarkers are exploratory objectives.	365 days
Secondary	Safety and Tolerability-AE/SAE - Vital Signs	Treatment Emergent Adverse Event/Serious Adverse Event (TEAEs/SAEs) related to vital signs. Assessment will be made by summarizing the percentage of subjects with changes from baseline through (sitting blood pressure, resting heart rate, and temperature). Changes from baseline deemed clinically significant or associates with AEs (heart rate, pulse rate, QRS, QT, and correct QT).	365 days