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Keep this study
Lead
AbbVie
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).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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;
Clareo Health | Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
