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Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
Sponsor: AbbVie
Summary
Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
81
Start Date
2023-04-24
Completion Date
2025-05-30
Last Updated
2026-06-15
Healthy Volunteers
No
Conditions
Interventions
NX-13 250mg
NX-13 250mg tablet, plus 2 placebo tablets
NX-13 750mg
NX-13 250mg tablets times 3 to equal 750mg
NX-13 Placebo
NX-13 Placebo tablets times 3 for blinding purposes
Locations (35)
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
St 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
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
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 Góra, Poland
VITA LONGA Clinic - Katowice
Katowice, Poland
Krakowska Przychodnia FutureMeds
Krakow, 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
RiverMED Poradnie Specjalistyczne Poznań
Poznan, 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
Torun, Poland
H-T Centrum Medyczne
Tychy, Poland
Office of Jaroslaw Kierkus, Dr N Med
Warsaw, Poland
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
Wroclaw, Poland
Zabobrze Centrum Medyczne
Wroclaw, Poland
Centrum Diagnostyczno - Lecznicze Barska
Włocławek, Poland