Study of DISC-0974-201 in Participants With IBD and Anemia
Trial Parameters
Brief Summary
This is a Phase 2, multicenter, randomized, double-blind placebo-controlled study of DISC-0974 to evaluate safety, tolerability, and efficacy in participants with IBD and anemia of inflammation.
Eligibility Criteria
Inclusion Criteria: Participants must meet all the following criteria at screening (unless otherwise specified) to be eligible for enrollment in the study: 1. Aged ≥18 years at the time of signing informed consent. 2. Established diagnosis of IBD (CD, UC, or IBD-unclassified) based on documented findings on both endoscopy and histopathology. 3. Baseline endoscopy at screening with modified Mayo Score for UC and CDAI for Crohn's Disease to include mild disease as defined below: a. CDAI of \<220 and SES-CD of 0 to 6 (CD/IBD-unclassified) modified Mayo Score of \<5 points and Mayo endoscopic subscore of 0 to 1 (UC/IBD-unclassified). 4. Are symptomatic from anemia as assessed by the Investigator despite optimized, stable conventional IBD-directed therapy for 3 months. 5. Hgb ≥7 AND \<12 g/dL for females and ≥7 AND \<13 g/dL for males (local lab) at screening. 6. Have symptomatic anemia defined as: 1. Hgb ≤10 g/dL and symptomatic as assessed by Investigator (fatigue, shortness of breath at