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

April 30, 2026 updated by: Disc Medicine, Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • One of a Kind Clinical Research Center, LLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florin Gaidici, MD
    • Florida
      • Doral, Florida, United States, 33172
      • Kissimmee, Florida, United States, 34741
        • Recruiting
        • Clinical Research of Osceola, LLC
        • Contact:
        • Principal Investigator:
          • Basher Atiquzzaman, MD
      • Miami, Florida, United States, 33176
      • Miami Lakes, Florida, United States, 33015
        • Recruiting
        • Ezy Medical Research, Co
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Paoli-Bruno, MD, MBA, FACHE, CPE, FAAFP
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Guardian Angel Research, Inc
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mario F Hernandez, MD
    • Missouri
    • Texas
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • One of a Kind Clinical Research Center, LLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sushovan Guha, MD, MA, PhD, FASGE, AGAF
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Siena Research Network
        • Contact:
        • Principal Investigator:
          • Mehjabin Parkar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
DISC-0974 60 mg (n = 14) administered subcutaneously (SC) every 28 days for 3 doses
Drug: DISC-0974
DISC-0974 is administered subcutaneously.
Placebo Comparator: Placebo
Placebo (n = 7) administered SC every 28 days for 3 doses
Drug: Placebo
Placebo is administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal change from baseline in Hgb through Day 85
Time Frame: up to 85 days
up to 85 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events
Time Frame: Up to 85 days
Up to 85 days
Incidence of clinically abnormal vital signs
Time Frame: Up to 85 days
Up to 85 days
Incidence of clinically abnormal physical exam
Time Frame: Up to 85 days
Up to 85 days
Incidence of clinically abnormal electrocardiograms
Time Frame: Up to 85 days
Up to 85 days
Incidence of abnormal laboratory test results
Time Frame: Up to 85 days
Up to 85 days
Change from baseline in concentration of iron laboratory parameters
Time Frame: Up to 85 days
Up to 85 days
Change from baseline of reticulocyte count
Time Frame: Up to 85 days
Up to 85 days
Change from baseline of reticulocyte hemoglobin content (CHr)
Time Frame: Up to 85 days
Up to 85 days
Change from baseline of red blood cell (RBC) count
Time Frame: Up to 85 days
Up to 85 days
Mean change in Hgb from baseline through Day 85
Time Frame: Up to 85 days
Proportion of participants that achieve Hgb increase ≥1 g/dL and ≥ 2 g/dL through Day 85. Proportion of participants that hit dose holding criteria (Hgb increase of ≥2 g/dL from baseline or absolute Hgb of ≥15 g/dL)
Up to 85 days
Cmax-Maximum drug concentration measured in plasma
Time Frame: Up to 85 days
Up to 85 days
Tmax-Time of maximum drug concentration
Time Frame: Up to 85 days
Up to 85 days
AUC-Area under the drug concentration time curve
Time Frame: Up to 85 days
Up to 85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Disc Medicine, Inc

Investigators

  • Study Director: Will Savage, MD, PhD, Disc Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DISC-0974-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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