Study of DISC-0974-201 in Participants With IBD and Anemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDisc Medicine, Inc
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 groupsSponsors and collaborators
Source ClinicalTrials.gov