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Study of DISC-0974-201 in Participants With IBD and Anemia

ConditionsInflammatory Bowel Disease (IBD)AnemiaInflammatory Bowel Disease (IBD); 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • DISC-0974

    Drug

    DISC-0974 is administered subcutaneously.

  • Placebo

    Drug

    Placebo is administered subcutaneously

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: ActiveExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximal change from baseline in Hgb through Day 85

Time frame
up to 85 days

Secondary outcomes

1

Incidence of treatment-emergent adverse events

Time frame
Up to 85 days
2

Incidence of clinically abnormal vital signs

Time frame
Up to 85 days
3

Incidence of clinically abnormal physical exam

Time frame
Up to 85 days
4

Incidence of clinically abnormal electrocardiograms

Time frame
Up to 85 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Disc Medicine, Inc

Lead sponsor

Source ClinicalTrials.gov
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