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

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NX-13 250mg
NX-13 750mg
NX-13 Placebo
Sponsored by
Landos Biopharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring ulcerative colitis, moderate, severe

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Orlando Health, Inc.Recruiting
  • GCP Clinical ResearchRecruiting
  • Digestive Health Center of MichiganRecruiting
  • Washington University School of Medicine in St. LouisRecruiting
  • INTEGRIS Baptist Medical CenterRecruiting
  • GI Alliance Research - GarlandRecruiting
  • GI Alliance - Texas Digestive Disease ConsultantsRecruiting
  • GI Alliance ResearchRecruiting
  • Medical College of Wisconsin
  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
  • Azienda Ospedaliera - Universitaria Sant' Andrea
  • Azienda Ospedaliera San Camillo Forlanini
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
  • IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
  • Azienda Ospedaliera Ordine Mauriziano di Torino
  • ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy
  • Przychodnia Vitamed NFZ
  • VITA LONGA Clinic - Katowice
  • Uniwersytet Medyczny w Łodzi
  • RiverMED Poradnie Specjalistyczne Poznań
  • Twoja Przychodnia Opolskie Centrum Medyczne
  • Centrum Medyczne SOPMED
  • Niepubliczny Zakład Opieki Zdrowotnej SONOMED
  • Twoja Przychodnia Szczecińskie Centrum Medyczne
  • H-T Centrum Medyczne
  • Office of Jaroslaw Kierkus, Dr N Med
  • Centrum Diagnostyczno - Lecznicze Barska
  • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
  • Zabobrze Centrum Medyczne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

NX-13 250mg

NX-13 750mg

NX-13 Placebo

Arm Description

Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.

Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.

Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
February 13, 2023
Last Updated
September 14, 2023
Sponsor
Landos Biopharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05785715
Brief Title
Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Landos Biopharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
ulcerative colitis, moderate, severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NX-13 250mg
Arm Type
Experimental
Arm Description
Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.
Arm Title
NX-13 750mg
Arm Type
Experimental
Arm Description
Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.
Arm Title
NX-13 Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.
Intervention Type
Drug
Intervention Name(s)
NX-13 250mg
Intervention Description
NX-13 250mg tablet, plus 2 placebo tablets
Intervention Type
Drug
Intervention Name(s)
NX-13 750mg
Intervention Description
NX-13 250mg tablets times 3 to equal 750mg
Intervention Type
Drug
Intervention Name(s)
NX-13 Placebo
Intervention Description
NX-13 Placebo tablets times 3 for blinding purposes
Primary Outcome Measure Information:
Title
To assess the clinical activity of oral NX-13 vs placebo
Description
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.
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Safety and Tolerability-AE/SAE - Hematology
Description
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.
Time Frame
365 days
Title
Safety and Tolerability-AE/SAE - Chemistry
Description
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.
Time Frame
365 days
Title
Safety and Tolerability-AE/SAE - Vital Signs
Description
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).
Time Frame
365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Lopez, DVM
Phone
540-218-2232
Email
clinicaloperations@landosbiopharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn Louro, VP
Phone
540-218-2232
Email
clinicaloperations@landosbiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Catalidi, MD
Organizational Affiliation
Landos Biopharma Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Health, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
GCP Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Health Center of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
INTEGRIS Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance Research - Garland
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance - Texas Digestive Disease Consultants
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76003
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance Research
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
City
Leuven
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera - Universitaria Sant' Andrea
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Rome
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
City
San Giovanni Rotondo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Ordine Mauriziano di Torino
City
Torino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy
City
Bydgoszcz
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Przychodnia Vitamed NFZ
City
Bydgoszcz
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
VITA LONGA Clinic - Katowice
City
Katowice
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Uniwersytet Medyczny w Łodzi
City
Lodz
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
RiverMED Poradnie Specjalistyczne Poznań
City
Poznan
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Twoja Przychodnia Opolskie Centrum Medyczne
City
Poznan
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Medyczne SOPMED
City
Sopot
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej SONOMED
City
Szczecin
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Twoja Przychodnia Szczecińskie Centrum Medyczne
City
Szczecin
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
H-T Centrum Medyczne
City
Tychy
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Office of Jaroslaw Kierkus, Dr N Med
City
Warszawa
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Diagnostyczno - Lecznicze Barska
City
Wloclawek
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
City
Wrocław
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Zabobrze Centrum Medyczne
City
Wrocław
Country
Poland
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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