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DISC-0974-201 for adults with IBD-related anemia

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

Phase 2 Interventional Disc Medicine, Inc · NCT07368972

This Phase 2 trial will test whether DISC-0974-201 helps adults with inflammatory bowel disease who have anemia driven by inflammation.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment21 (estimated)
Ages18 Years and up
SexAll
SponsorDisc Medicine, Inc Industry-sponsored
Locations9 sites (Scottsdale, Arizona and 8 other locations)
Trial IDNCT07368972 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial enrolling adults with confirmed Crohn's disease, ulcerative colitis, or IBD-unclassified who have symptomatic anemia of inflammation. Participants will be randomized to receive DISC-0974 or placebo and will be followed for safety, tolerability, and signs of improved anemia. Key eligibility includes endoscopy- and histology-confirmed IBD with mild endoscopic/clinical activity, symptomatic anemia despite stable IBD therapy, and hemoglobin within protocol-specified ranges. The study compares hemoglobin and clinical symptom outcomes between groups while monitoring adverse events.

Who should consider this trial

Good fit: Adults (≥18) with endoscopy- and histology-confirmed IBD (CD, UC, or IBD-unclassified), mild disease activity per CDAI or modified Mayo, symptomatic anemia despite ≥3 months of stable IBD therapy, and hemoglobin within the protocol-specified ranges are the intended participants.

Not a fit: People with severe active IBD, anemia due primarily to bleeding or non-inflammatory causes, or who do not meet the hemoglobin or stability-on-therapy criteria are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, DISC-0974 could raise hemoglobin levels and reduce anemia symptoms in people with IBD-related anemia.

How similar studies have performed: Some early-phase programs targeting anemia of inflammation have shown promising signals, but DISC-0974's effectiveness specifically is not yet established and is being tested in this Phase 2 trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 endoscopic subscore of 0 to 1 (UC/IBD-unclassified).
4. Are symptomatic from anemia as assessed by the Investigator despite optimized, stable conventional IBD-directed therapy for 3 months.
5. Hgb ≥7 AND \<12 g/dL for females and ≥7 AND \<13 g/dL for males (local lab) at screening.
6. Have symptomatic anemia defined as:

   1. Hgb ≤10 g/dL and symptomatic as assessed by Investigator (fatigue, shortness of breath at rest or on minimal exertion, palpitations, tachycardia, orthostatic hypotension or dizziness), or
   2. Hgb \>10 g/dL and a minimum score of 4 on the Numeric Rating Scale for Fatigue.
7. Serum ferritin ≥75 μg/L at screening (local lab).
8. AST and ALT \<2× upper limit of normal (ULN) at screening.
9. Total and direct bilirubin \<ULN at screening.
10. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.
11. If female, then EITHER postmenopausal (defined as at least 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) \>40 mIU/mL, or at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) during the study and for at least 8 weeks after the last dose of study drug:

    * Stable hormonal contraceptive (≥3 months)
    * Intrauterine device in place for at least 3 months
    * Tubal ligation or single male partner with vasectomy
12. If a male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:

    * Stable hormonal contraceptive (≥3 months; female partner)
    * Intrauterine device in place for at least 3 months (female partner)
    * Surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)
    * Confirmed successful vasectomy
13. Able to understand and provide written informed consent.
14. Able to comply with all study procedures.

Exclusion Criteria:

Participants meeting any of the following criteria at screening are not eligible for study enrollment:

1. 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.
2. 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.
3. Planned change in IBD directed therapy within 3 months of screening.
4. Moderate or severe IBD assessed during screening period. Defined as:

   1. CD/IBD-unclassified: participants with a CDAI score ≥220 or SES-CD ≥7
   2. UC/IBD-unclassified: modified Mayo Score of ≥6 or endoscopic subscore of 3
   3. Fever, tachycardia, or anticipated need for surgery in the next 3 months
5. Hospitalization within 30 days prior to screening.
6. Positive direct antiglobulin test with reactive eluate at screening or medical history at screening of active hemolytic anemia.
7. Gross gastrointestinal blood loss (eg, visible rectal bleeding, hematochezia, melena) within 4 weeks prior to screening.
8. Active gastrointestinal bleeding requiring hospitalization, blood transfusion, or endoscopy hemostasis within 8 weeks prior to screening.
9. Current use of Janus kinase (JAK) inhibitor.
10. History of hereditary hemochromatosis.
11. History of Primary Sclerosis Cholangitis.
12. History of hemoglobinopathy or intrinsic RBC defect associated with anemia.
13. History of total splenectomy.
14. Hematopoietic stem cell or solid organ transplant within the past 10 years.
15. Medical history of anemia from Vitamin B12 or folate deficiency or infection in the 3 months prior to screening.
16. Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to screening.
17. Medical history of clinically significant thrombotic disorder.
18. If female, pregnant or breastfeeding.
19. Any major surgery within 8 weeks before screening or incomplete recovery from any previous surgery.
20. Current or recent systemic corticosteroid use (within 3 months of screening).
21. Endoscopic abnormalities concerning for colon cancer on baseline endoscopy.
22. History of malignancy within the last 3 years. The following history/concurrent conditions are allowed: basal or squamous cell carcinoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis clinical staging system). A history of completed treatment (medical or surgical) of Stage 1-2 cancers may be permitted with prior Sponsor agreement.
23. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and/or therapeutic devices within 30 days of screening.
24. A history or known allergic reaction to any investigational product excipients.
25. History of ADA formation with anaphylaxis.
26. History of inadequately controlled heart failure (New York Heart Association Classification 3 or 4) and/or have a history of left ventricular ejection fraction \<35%.
27. Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement, despite appropriate treatment).
28. Active infectious gastroenteritis including clostridium difficile colitis or viral enteritis (eg, cytomegalovirus).
29. HIV positive, active hepatitis B virus surface antigen (HBV), or active hepatitis C virus antibody (HCV).
30. Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study.
31. Any condition or concomitant medication that would confound the ability to interpret data from the study.

Where this trial is running

Scottsdale, Arizona and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Inflammatory Bowel DiseaseAnemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.