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

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

Detailed Description
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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).

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: NX-13 250mg
* Drug: NX-13 750mg
* Drug: NX-13 Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NX-13 250mg<br>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. | Drug: NX-13 250mg<br>* NX-13 250mg tablet, plus 2 placebo tablets<br>|
| Experimental: NX-13 750mg<br>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. | Drug: NX-13 750mg<br>* NX-13 250mg tablets times 3 to equal 750mg<br>|
| Placebo Comparator: NX-13 Placebo<br>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. | Drug: NX-13 Placebo<br>* NX-13 Placebo tablets times 3 for blinding purposes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis, moderate, severe