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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT05785715

Run by

AbbVie

People needed

81

Starts

2023-04-24

Expected to finish

2025-05-30

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• 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

Full record on ClinicalTrials.gov

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