21 Participants NeededMy employer runs this trial

DISC-0974 for IBD and Anemia

Recruiting at 14 trial locations
DM
Overseen ByDisc Medicine Clinical Trials
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called DISC-0974 for individuals with inflammatory bowel disease (IBD) who also have anemia due to inflammation. The study includes two groups: one receiving the actual treatment and another receiving a placebo for comparison. Suitable participants have been diagnosed with IBD and experience symptoms from anemia, such as fatigue or shortness of breath, despite stable IBD treatment for the past three months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires a 2-day break from oral iron supplements before certain lab tests and a 30-day break from treatments like blood transfusions, EPO-stimulating agents, or IV iron before screening. Other medications are not specifically mentioned, so it's best to discuss with the study team.

Is there any evidence suggesting that DISC-0974 is likely to be safe for humans?

Research has shown that DISC-0974 has been safe and well-tolerated in earlier studies. For instance, when tested in smaller doses, participants experienced manageable side effects.

DISC-0974 is an experimental treatment targeting a protein called hemojuvelin, which influences iron levels in the body. By increasing iron levels, it helps treat anemia (a low red blood cell count) caused by inflammation.

Additionally, the FDA granted DISC-0974 Fast Track status for treating anemia related to chronic kidney disease, indicating it as a promising treatment option.

While these results are promising, new trials are necessary to confirm safety and effectiveness in different conditions and larger groups.12345

Why do researchers think this study treatment might be promising for IBD and anemia?

Most treatments for inflammatory bowel disease (IBD) and anemia focus on reducing inflammation or supplementing iron. But DISC-0974 works differently, targeting a protein involved in regulating iron in the body. This innovative approach could help improve iron levels without the need for traditional iron supplements, which often come with side effects. Researchers are excited because DISC-0974 is administered subcutaneously every 28 days, providing a potentially more convenient and better-tolerated option compared to current treatments.

What evidence suggests that DISC-0974 might be an effective treatment for IBD and anemia?

Research shows that DISC-0974, which participants in this trial may receive, may help treat anemia linked to inflammation in inflammatory bowel disease (IBD). Anemia occurs when there aren't enough healthy red blood cells. In earlier studies, DISC-0974 lowered levels of hepcidin, a protein that can cause anemia if elevated. Lowering hepcidin benefits the body by promoting the production of more red blood cells. Animal studies also demonstrated that DISC-0974 improved anemia in conditions similar to IBD. Previous trials in other types of anemia found that DISC-0974 was safe and well-tolerated. These results suggest it could help people with anemia related to IBD.16789

Who Is on the Research Team?

WS

Will Savage, MD, PhD

Principal Investigator

Disc Medicine

Are You a Good Fit for This Trial?

This trial is for adults (18+) with inflammatory bowel disease (Crohn's, ulcerative colitis, or unclassified IBD) who have anemia causing symptoms like fatigue or shortness of breath, despite stable treatment. Participants must have certain blood test results and generally healthy liver and kidney function.

Inclusion Criteria

I feel tired or weak from anemia despite 3 months of treatment for my bowel disease.
I have been diagnosed with IBD confirmed by endoscopy and biopsy results.
I am 18 years old or older.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DISC-0974 or placebo subcutaneously every 28 days for 3 doses

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DISC-0974

Trial Overview

The study compares a new drug called DISC-0974 to a placebo in people with IBD-related anemia. It is randomized and double-blind, meaning participants are randomly assigned to groups and neither they nor the researchers know which treatment they're getting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Disc Medicine, Inc

Lead Sponsor

Trials
6
Recruited
580+

Citations

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

This is a Phase 2, multicenter, randomized, double-blind placebo-controlled study of DISC-0974 to evaluate safety, tolerability, and efficacy in ...

Disc Medicine to Present Data from Phase 1b Trial of DISC ...

The poster presentation will provide a data update from the Phase 1b, randomized, placebo-controlled study of DISC-0974 in patients with non- ...

P1559: DISC-0974, A FIRST-IN-HUMAN ANTI ... - PMC - NIH

Summary/Conclusion: Preliminary analysis of data from the 7 mg IV and 14 mg SC DISC-0974 cohorts shows an acceptable safety and tolerability profile, as well as ...

INTRODUCTION AIM METHODS RESULTS CONCLUSIONS

DISC-0974-103 is a Phase 1b, double-blind, placebo-controlled study. (NCT05745883) to assess safety, tolerability, PK, PD, and efficacy of.

Disc Medicine's RALLY-IBD Trial Puts a Spotlight on ...

The trial tests DISC-0974, an injectable drug given under the skin. It is designed to improve anemia of inflammation in people with IBD, ...

6.

discmedicine.com

discmedicine.com/disc-0974

DISC-0974 (Anti-HJV mAb) Anemia of Inflammation

DISC-0974 is an investigational anti-hemojuvelin (HJV) monoclonal antibody designed to suppress the production of hepcidin and enhance iron levels to treat ...

First‐in‐Human Phase 1 Study Evaluating the Safety ...

DISC-0974 decreased the expression of Hamp, the gene encoding hepcidin, in a mouse model of heat-killed Brucella abortus-triggered inflammation ...

FDA Gives Fast Track Designation to Anemia Treatment for ...

The FDA has granted Fast Track designation DISC-0974 for the treatment of anemia in patients with nondialysis-dependent chronic kidney ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38515275/

First-in-Human Phase 1 Study Evaluating the Safety, ...

DISC-0974 is a monoclonal antibody that binds to hemojuvelin and blocks bone morphogenetic protein signaling, thereby suppressing hepcidin production.