Clinical trial NCT05785715: Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis
moderate
severe
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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;

Primary outcomes:
measure: To assess the clinical activity of oral NX-13 vs placebo
timeFrame: 365 days
Secondary outcomes:
measure: Safety and Tolerability-AE/SAE - Hematology
timeFrame: 365 days
measure: Safety and Tolerability-AE/SAE - Chemistry
timeFrame: 365 days
measure: Safety and Tolerability-AE/SAE - Vital Signs
timeFrame: 365 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research
state: Florida
city: Chesterfield
country: United States
facility: Digestive Health Center of Michigan
state: Michigan
city: Troy
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Oklahoma City
country: United States
facility: Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center
state: Oklahoma
city: Garland
country: United States
facility: Digestive Health Associates of Texas-GI Alliance Research-Garland
state: Texas
city: Mansfield
country: United States
facility: Digestive Health Associates of Texas-GI Alliance
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants-GI Alliance Research
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Milan
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
city: Roma
country: Italy
facility: Azienda Ospedaliera - Universitaria Sant' Andrea
city: Rozzano
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Bydgoszcz
country: Poland
facility: ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy
city: Bydgoszcz
country: Poland
facility: Przychodnia Vitamed NFZ
city: Jelenia Gora
country: Poland
facility: AmiCare Centrum Medyczne
city: Katowice
country: Poland
facility: VITA LONGA Clinic - Katowice
city: Kraków
country: Poland
facility: Krakowska Przychodnia FutureMeds
city: Lodz
country: Poland
facility: AmiCare Sp. z o.o. Sp.k.
city: Opoczno
country: Poland
facility: Amicare Sp z o.o. S.K
city: Opole
country: Poland
facility: Twoja Przychodnia Opolskie Centrum Medyczne
city: Poznan
country: Poland
facility: RiverMED Poradnie Specjalistyczne Poznań
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Szczecin
country: Poland
facility: Sonomed Sp. z o.o. Centrum Medyczne
city: Szczecin
country: Poland
facility: Twoja Przychodnia Szczecińskie Centrum Medyczne
city: Toruń
country: Poland
facility: Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
city: Tychy
country: Poland
facility: H-T Centrum Medyczne
city: Warszawa
country: Poland
facility: Office of Jaroslaw Kierkus, Dr N Med
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno - Lecznicze Barska
city: Wrocław
country: Poland
facility: Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
city: Wrocław
country: Poland
facility: Zabobrze Centrum Medyczne
Study officials:
affiliation: AbbVie
name: AbbVie
role: STUDY_DIRECTOR
References: