RALLY-IBD: A Phase 2 Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of DISC-0974 in Participants With Inflammatory Bowel Disease and Anemia of Inflammation
Disc Medicine, Inc
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 endoscopi…
Interventions
- DrugDISC-0974
DISC-0974 is administered subcutaneously.
- DrugPlacebo
Placebo is administered subcutaneously
Locations (9)
- One of a Kind Clinical Research Center, LLCScottsdale, Arizona
- Dolphin Medical ResearchDoral, Florida
- Clinical Research of Osceola, LLCKissimmee, Florida
- Anchor Medical Research, LLCMiami, Florida
- Ezy Medical Research, CoMiami Lakes, Florida
- Guardian Angel Research, IncTampa, Florida