Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring ulcerative colitis, moderate, severe
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;
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
Experimental
Experimental
Placebo Comparator
NX-13 250mg
NX-13 750mg
NX-13 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.
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.