Actively Recruiting
Study of DISC-0974-201 in Participants With IBD and Anemia
Led by Disc Medicine, Inc · Updated on 2026-05-04
21
Participants Needed
9
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of DISC-0974-201 in Participants With IBD and Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at consent
- Established diagnosis of IBD (Crohn's disease, ulcerative colitis, or IBD-unclassified) confirmed by endoscopy and histopathology
- Mild disease activity measured by CDAI <220 and SES-CD 0-6 for Crohn's or modified Mayo Score <5 and Mayo endoscopic subscore 0-1 for ulcerative colitis
- Symptomatic anemia despite stable conventional IBD therapy for 3 months
- Hemoglobin ≥7 and <12 g/dL for females or ≥7 and <13 g/dL for males at screening
- Symptomatic anemia defined by hemoglobin ≤10 g/dL with symptoms or hemoglobin >10 g/dL with fatigue score ≥4
- Serum ferritin ≥75 µg/L at screening
- AST and ALT less than 2 times the upper limit of normal
- Total and direct bilirubin below upper limit of normal
- Estimated glomerular filtration rate ≥30 mL/min/1.73 m2
- Females must be postmenopausal, surgically sterile, or agree to use effective contraception during and 8 weeks after study
- Males with female partners of childbearing potential must agree to use effective contraception during and 8 weeks after study
- Able to understand and provide written informed consent
- Able to comply with all study procedures
You will not qualify if you...
- Use of oral iron or iron-containing supplements within 2 days prior to screening without washout
- Treatment with blood transfusion, ESA, or IV iron within 30 days prior to screening without washout
- Planned change in IBD therapy within 3 months of screening
- Moderate or severe IBD defined by CDAI ≥220 or SES-CD ≥7 for Crohn's, or modified Mayo Score ≥6 or endoscopic subscore 3 for ulcerative colitis
- Fever, tachycardia, or planned surgery within 3 months
- Hospitalization within 30 days prior to screening
- Active hemolytic anemia or positive direct antiglobulin test
- Recent significant gastrointestinal bleeding within 4 to 8 weeks prior to screening
- Current use of Janus kinase (JAK) inhibitors
- History of hereditary hemochromatosis, primary sclerosing cholangitis, hemoglobinopathy, or intrinsic red blood cell defect
- History of total splenectomy
- Stem cell or organ transplant within past 10 years
- Anemia due to Vitamin B12 or folate deficiency or infection within 3 months
- Recent thrombotic events or significant thrombotic disorders
- Pregnant or breastfeeding females
- Major surgery within 8 weeks or incomplete recovery
- Recent systemic corticosteroid use within 3 months
- Endoscopic findings concerning for colon cancer
- History of malignancy within last 3 years except certain skin and in situ cancers
- Participation in other investigational studies within 30 days
- Allergic reaction to investigational product excipients
- History of antibody formation with anaphylaxis
- Inadequately controlled heart failure or low ejection fraction
- Uncontrolled infections or active infectious gastroenteritis
- Positive for HIV, active hepatitis B or C
- Significant medical, laboratory, or psychiatric conditions preventing participation
- Conditions or medications confounding study data interpretation
AI-Screening
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Trial Site Locations
Total: 9 locations
1
One of a Kind Clinical Research Center, LLC
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Dolphin Medical Research
Doral, Florida, United States, 33172
Actively Recruiting
3
Clinical Research of Osceola, LLC
Kissimmee, Florida, United States, 34741
Actively Recruiting
4
Anchor Medical Research, LLC
Miami, Florida, United States, 33176
Actively Recruiting
5
Ezy Medical Research, Co
Miami Lakes, Florida, United States, 33015
Actively Recruiting
6
Guardian Angel Research, Inc
Tampa, Florida, United States, 33614
Actively Recruiting
7
KAD Clinical Research
St Louis, Missouri, United States, 63123
Actively Recruiting
8
One of a Kind Clinical Research Center, LLC
Kingwood, Texas, United States, 77339
Actively Recruiting
9
Siena Research Network
Sugar Land, Texas, United States, 77479
Actively Recruiting
Research Team
D
Disc Medicine Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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