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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Disc Medicine, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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