Study of DISC-0974-201 in Participants With IBD and Anemia (NCT07368972) | Clinical Trial Compass
RecruitingPhase 2
Study of DISC-0974-201 in Participants With IBD and Anemia
United States21 participantsStarted 2026-02-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximal change from baseline in Hgb through Day 85
. 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
. 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.