Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
Study Details
Study Description
Brief Summary
Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NX-13 250mg 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
NX-13 250mg tablet, plus 2 placebo tablets
|
| Experimental: NX-13 750mg 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
NX-13 250mg tablets times 3 to equal 750mg
|
| Placebo Comparator: 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. |
Drug: NX-13 Placebo
NX-13 Placebo tablets times 3 for blinding purposes
|
Outcome Measures
Primary Outcome Measures
- To assess the clinical activity of oral NX-13 vs placebo [365 days]
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 [365 days]
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 [365 days]
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 [365 days]
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).
Eligibility Criteria
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;
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Landos Biopharma Inc.
Investigators
- Principal Investigator: Fabio Catalidi, MD, Landos Biopharma Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NX-13-201