Inflammatory Bowel Disease (IBD)Phase 2NCT07368972
Study of DISC-0974-201 in Participants With IBD and Anemia
A Phase 2 study testing DISC-0974 in people with Inflammatory Bowel Disease (IBD) and Anemia, run by Disc Medicine, Inc at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Anemia, Inflammatory Bowel Disease (IBD); Anemia
- What is being tested?
- DISC-0974
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 15 sitesUnited States
- Study dates
- 20 Feb 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all the following criteria at screening (unless otherwise specified) to be eligible for enrollment in the study:
- 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.
- Baseline endoscopy at screening with modified Mayo Score for UC and CDAI for Crohn's Disease to include mild disease as defined below:
- 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).
- Are symptomatic from anemia as assessed by the Investigator despite optimized, stable conventional IBD-directed therapy for 3 months.
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- Hgb ≥7 AND <12 g/dL for females and ≥7 AND <13 g/dL for males (local lab) at screening.
- Have symptomatic anemia defined as:
- 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
- Hgb >10 g/dL and a minimum score of 4 on the Numeric Rating Scale for Fatigue.
- Serum ferritin ≥75 μg/L at screening (local lab).
- AST and ALT <2× upper limit of normal (ULN) at screening.
- Total and direct bilirubin <ULN at screening.
- Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.
- 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
- 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
- Able to understand and provide written informed consent.
- Able to comply with all study procedures.
Who cannot join
- Participants meeting any of the following criteria at screening are not eligible for study enrollment:
- 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.
- Moderate or severe IBD assessed during screening period. Defined as:
- CD/IBD-unclassified: participants with a CDAI score ≥220 or SES-CD ≥7
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- UC/IBD-unclassified: modified Mayo Score of ≥6 or endoscopic subscore of 3
- Fever, tachycardia, or anticipated need for surgery in the next 3 months
- Hospitalization within 30 days prior to screening.
- Positive direct antiglobulin test with reactive eluate at screening or medical history at screening of active hemolytic anemia.
- Gross gastrointestinal blood loss (eg, visible rectal bleeding, hematochezia, melena) within 4 weeks prior to screening.
- Active gastrointestinal bleeding requiring hospitalization, blood transfusion, or endoscopy hemostasis within 8 weeks prior to screening.
- Current use of Janus kinase (JAK) inhibitor.
- History of hereditary hemochromatosis.
- History of Primary Sclerosis Cholangitis.
- History of hemoglobinopathy or intrinsic RBC defect associated with anemia.
- History of total splenectomy.
- Hematopoietic stem cell or solid organ transplant within the past 10 years.
- Medical history of anemia from Vitamin B12 or folate deficiency or infection in the 3 months prior to screening.
- Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to screening.
- Medical history of clinically significant thrombotic disorder.
- If female, pregnant or breastfeeding.
- Any major surgery within 8 weeks before screening or incomplete recovery from any previous surgery.
- Current or recent systemic corticosteroid use (within 3 months of screening).
- Endoscopic abnormalities concerning for colon cancer on baseline endoscopy.
- 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.
- Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and/or therapeutic devices within 30 days of screening.
- A history or known allergic reaction to any investigational product excipients.
- History of ADA formation with anaphylaxis.
- 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%.
- Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement, despite appropriate treatment).
- Active infectious gastroenteritis including clostridium difficile colitis or viral enteritis (eg, cytomegalovirus).
- HIV positive, active hepatitis B virus surface antigen (HBV), or active hepatitis C virus antibody (HCV).
- Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study.
- Any condition or concomitant medication that would confound the ability to interpret data from the study.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Gastro Health- Birmingham
Birmingham, Alabama, 35235
Adrian Robnison, 1-888-909-0052, adrianrobinson@gastrohealth.com
Robert Shaffer, MD
- Recruiting
Gastro Health - Cincinnati
Cincinnati, Ohio, 45219
Shelia Richardson, 513-247-5947, srichardson@gastrohealth.com
Steven Gay
- Recruiting
Gastro Health - Blue Ash Care Center
Cincinnati, Ohio, 45242
Gisela Spear, 909-747-7503, giselaspear@gastrohealth.com
Robert Isfort, MD
- Recruiting
Dolphin Medical Research
Doral, Florida, 33172
Alicia Lopez, 305-510-3392, alopez@dolphinmedicalresearch.com
Ivette Cuevas, 305-870-5999, icuevas@dolphinmedicalresearch.com
- Recruiting
One of a Kind Clinical Research Center, LLC
Kingwood, Texas, 77339
Natalie Verduzco, 346-847-9375, natalie@1-oak.net
Brittney Calivoso, 346-847-9375, brittney@1-oak.net
- Recruiting
Clinical Research of Osceola, LLC
Kissimmee, Florida, 34741
Victor Sanchez, 407-954-4016, vsanchez@crosceola.com
Basher Atiquzzaman, MD
- Recruiting
UCLA Catche & Tamar Manoukian Division of Digestive Diseases
Los Angeles, California, 90095
Xiaoxiao Yin, 310-206-3778, xiaoxiaoyin@mednet.ucla.edu
Juliana Reist, 310-206-3778, jreist@mednet.ucla.edu
- Recruiting
Anchor Medical Research, LLC
Miami, Florida, 33176
Yoany Rodriguez, 786-384-7005, YRodriguez@anchormedicalresearch.com
Aslenys Garcia, 786-384-7005, agarcia@anchormedicalresearch.com
- Recruiting
Gastro Health - Galloway Care Center
Miami, Florida, 33176
Gisela Spear, 909-747-7503, giselaspear@gastrohealth.com
James Leavitt, MD
- Recruiting
Ezy Medical Research, Co
Miami Lakes, Florida, 33015
Priscilla Hernandez, 786-483-8162, phernandez@ezytrials.com
Katherine Torrado, 786-483-8162, ktorrado@ezytrials.com
- Recruiting
University Gastroenterology Clinical Research Department
Providence, Rhode Island, 02905
Katherine Marcil, 401-227-8393, Katherine.marcil@gialliance.com
Isabella Payne, 401-227-8393, Isabella.payne@gialliance.com
- Recruiting
One of a Kind Clinical Research Center, LLC
Scottsdale, Arizona, 85258
Dalena Tran, 602-820-6906, dalena@1-oak.net
Brittney Calivoso, 602-820-6906, brittney@1-oak.net
- Recruiting
KAD Clinical Research
St Louis, Missouri, 63123
Kristina Wriston, 1-314-254-3168, kwriston@kadclinicalresearch.com
Michael Tarvin, 1-314-254-3168, mtarvin@kadclinicalresearch.com
- Recruiting
Siena Research Network
Sugar Land, Texas, 77479
Shahin Mozaffari, 832 691 0205, shahin@srnus.com
Mehjabin Parkar, MD
- Recruiting
Guardian Angel Research, Inc
Tampa, Florida, 33614
Gabriela Morales, 813-512-7479, data2@garesearch.org
Claudia Rendon, 813-512-7479, reg02@garesearch.org
About this study
Official title: 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.
- Being tested
- DISC-0974, Placebo
- Medical subject headings
- Inflammatory Bowel Diseases, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISC-0974Drug
DISC-0974 is administered subcutaneously.
PlaceboDrug
Placebo is administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | DISC-0974 60 mg (n = 14) administered subcutaneously (SC) every 28 days for 3 doses Receives: Drug: DISC-0974 |
| Placebo | Placebo comparator | Placebo (n = 7) administered SC every 28 days for 3 doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal change from baseline in Hgb through Day 85
Measured: up to 85 days
Secondary outcomes (13)
Incidence of treatment-emergent adverse events
Measured: Up to 85 days
Incidence of clinically abnormal vital signs
Measured: Up to 85 days
Incidence of clinically abnormal physical exam
Measured: Up to 85 days
Incidence of clinically abnormal electrocardiograms
Measured: Up to 85 days
Incidence of abnormal laboratory test results
Measured: Up to 85 days
Change from baseline in concentration of iron laboratory parameters
Measured: Up to 85 days
Change from baseline of reticulocyte count
Measured: Up to 85 days
Change from baseline of reticulocyte hemoglobin content (CHr)
Measured: Up to 85 days
Change from baseline of red blood cell (RBC) count
Measured: Up to 85 days
Mean change in Hgb from baseline through Day 85
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)
Measured: Up to 85 days
Cmax-Maximum drug concentration measured in plasma
Measured: Up to 85 days
Tmax-Time of maximum drug concentration
Measured: Up to 85 days
AUC-Area under the drug concentration time curve
Measured: Up to 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start20 Feb 2026
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Disc Medicine, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Will Savage, MD, PhD, Study director, Disc Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368972
- Sponsor's protocol ID
- DISC-0974-201
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07368972
- Acronym / sponsor ID
- DISC-0974-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Disc Medicine, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: DISC-0974DISC-0974 60 mg (n = 14) administered subcutaneously (SC) every 28 days for 3 doses |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (n = 7) administered SC every 28 days for 3 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants must meet all the following criteria at screening (unless otherwise specified) to be eligible for enrollment in the study:
- 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.
- Baseline endoscopy at screening with modified Mayo Score for UC and CDAI for Crohn's Disease to include mild disease as defined below:
- Are symptomatic from anemia as assessed by the Investigator despite optimized, stable conventional IBD-directed therapy for 3 months.
Key exclusion criteria (35 listed)
- Participants meeting any of the following criteria at screening are not eligible for study enrollment:
- 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.
- Moderate or severe IBD assessed during screening period. Defined as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISC-0974DISC-0974 is administered subcutaneously. | Drug | Active |
| PlaceboPlacebo is administered subcutaneously | Drug | Placebo |
Primary outcome
Maximal change from baseline in Hgb through Day 85
Time frame: up to 85 days
13 secondary outcomes
Incidence of treatment-emergent adverse events
Time frame: Up to 85 days
Incidence of clinically abnormal vital signs
Time frame: Up to 85 days
Incidence of clinically abnormal physical exam
Time frame: Up to 85 days
Incidence of clinically abnormal electrocardiograms
Time frame: Up to 85 days
Incidence of abnormal laboratory test results
Time frame: Up to 85 days
Change from baseline in concentration of iron laboratory parameters
Time frame: Up to 85 days
Change from baseline of reticulocyte count
Time frame: Up to 85 days
Change from baseline of reticulocyte hemoglobin content (CHr)
Time frame: Up to 85 days
Change from baseline of red blood cell (RBC) count
Time frame: Up to 85 days
Mean change in Hgb from baseline through Day 85
Time frame: Up to 85 days
Cmax-Maximum drug concentration measured in plasma
Time frame: Up to 85 days
Tmax-Time of maximum drug concentration
Time frame: Up to 85 days
AUC-Area under the drug concentration time curve
Time frame: Up to 85 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Will Savage, MD, PhD study director
Disc Medicine
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DISC-0974 in people with Inflammatory Bowel Disease (IBD) and Anemia, run by Disc Medicine, Inc at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Disc Medicine Clinical Trials ((617) 674 9274, clinicaltrials@discmedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal change from baseline in Hgb through Day 85 (time frame: up to 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.