Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: NX-13 250mgDrug: NX-13 750mgDrug: NX-13 Placebo
- Registration Number
- NCT05785715
- Lead Sponsor
- AbbVie
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NX-13 250mg 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. NX-13 750mg 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. NX-13 Placebo 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
Trial Locations
- Locations (35)
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
🇮🇹Milan, Italy
Azienda Ospedaliera - Universitaria Sant' Andrea
🇮🇹Roma, Italy
Miami Clinical Research
🇺🇸Miami, Florida, United States
Orlando Health, Inc.
🇺🇸Orlando, Florida, United States
GCP Clinical Research
🇺🇸Tampa, Florida, United States
Digestive Health Center of Michigan
🇺🇸Chesterfield, Michigan, United States
Clinical Research Institute of Michigan
🇺🇸Troy, Michigan, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Digestive Health Associates of Texas-GI Alliance Research-Garland
🇺🇸Garland, Texas, United States
Digestive Health Associates of Texas-GI Alliance
🇺🇸Mansfield, Texas, United States
Texas Digestive Disease Consultants-GI Alliance Research
🇺🇸Southlake, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
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, Italy
ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Przychodnia Vitamed NFZ
🇵🇱Bydgoszcz, Poland
AmiCare Centrum Medyczne
🇵🇱Jelenia Gora, Poland
VITA LONGA Clinic - Katowice
🇵🇱Katowice, Poland
Krakowska Przychodnia FutureMeds
🇵🇱Kraków, Poland
RiverMED Poradnie Specjalistyczne Poznań
🇵🇱Poznan, Poland
AmiCare Sp. z o.o. Sp.k.
🇵🇱Lodz, Poland
Amicare Sp z o.o. S.K
🇵🇱Opoczno, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
🇵🇱Opole, Poland
Endoskopia Sp. z o.o.
🇵🇱Sopot, Poland
Sonomed Sp. z o.o. Centrum Medyczne
🇵🇱Szczecin, Poland
Twoja Przychodnia Szczecińskie Centrum Medyczne
🇵🇱Szczecin, Poland
Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
🇵🇱Toruń, Poland
H-T Centrum Medyczne
🇵🇱Tychy, Poland
Office of Jaroslaw Kierkus, Dr N Med
🇵🇱Warszawa, Poland
Centrum Diagnostyczno - Lecznicze Barska
🇵🇱Wloclawek, Poland
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
🇵🇱Wrocław, Poland
Zabobrze Centrum Medyczne
🇵🇱Wrocław, Poland