About this trial

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

Qualifiers

Aged ≥18 years at the time of signing informed consent.

Established diagnosis of IBD (CD, UC, or IBD-unclassified) based on documented findings on both endoscopy and histopathology.

Are symptomatic from anemia as assessed by the Investigator despite optimized, stable conventional IBD-directed therapy for 3 months.

Hgb ≥7 AND <12 g/dL for females and ≥7 AND <13 g/dL for males (local lab) at screening.

Disqualifiers

Treatment within 2 days prior to screening with oral iron or iron-containing supplements. Participants may be considered for the study if they undergo a 2-day washout period prior to screening labs for oral iron or iron-containing supplements. Between screening and 2 days prior to Day 1 visit, participants may continue oral iron or iron-containing supplements at the discretion of the Investigator, but any study-related lab draws will require a 48-hour washout from oral iron.

Treatment within 30 days prior to screening with any of the following anemia treatments: blood transfusion, EPO-stimulating agent (ESA), or IV iron. Participants may be considered for the study if they undergo a 30-day washout period for ESAs or IV iron prior to screening labs.

Planned change in IBD directed therapy within 3 months of screening.

CD/IBD-unclassified: participants with a CDAI score ≥220 or SES-CD ≥7

Trial design

Treatments tested in this trial

  • DISC-0974
  • Placebo

Treatment groups

21 Participants
are divided into 2 treatment groups

Locations

13
Arizona
One of a Kind Clinical Research Center, LLC85258, Scottsdale United States
Florida
Dolphin Medical Research33172, Doral United States
Clinical Research of Osceola, LLC34741, Kissimmee United States
Anchor Medical Research, LLC33176, Miami United States

Sponsors and collaborators

Disc Medicine, Inc

Lead sponsor