PRA023 for Crohn's Disease

(APOLLO-CD Trial)

No longer recruiting at 41 trial locations

Overseen By Prometheus Biosciences

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Prometheus Biosciences, Inc.

Must be taking: Corticosteroids, Immunosuppressants, Anti-TNF

Disqualifiers: Ulcerative colitis, Abscess, Stoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

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 PRA023 (also known as Tulisokibart or MK-7240) for people with Crohn's Disease. Participants will receive the treatment through an IV (a tube into a vein) to determine its impact on symptoms. The trial targets individuals with moderately to severely active Crohn's Disease who haven't responded to other treatments like steroids or certain immune therapies. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from an innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have had no response or intolerance to certain therapies, which might imply some changes to your current treatment. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that PRA023 is likely to be safe for humans?

Research has shown that PRA023, also known as tulisokibart, is generally well tolerated by people with moderate to severe Crohn's disease. In a previous study, tulisokibart demonstrated promising safety results, with most participants not experiencing serious side effects. While no treatment is completely without risk, current evidence suggests that PRA023 is generally safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's Disease?

Unlike the standard treatments for Crohn's disease, which often involve anti-inflammatory drugs or immune suppressants, PRA023 is unique because it is administered through an intravenous (IV) infusion, potentially allowing for more direct and efficient delivery of the medication. This treatment targets specific pathways involved in inflammation, which could result in fewer side effects compared to traditional therapies. Researchers are excited about PRA023 because it represents a potential new mechanism of action that could provide relief for patients who haven't responded well to existing treatments.

What evidence suggests that PRA023 might be an effective treatment for Crohn's Disease?

Research has shown that PRA023, also known as tulisokibart, might help treat moderate to severe Crohn's disease. Previous studies suggest that this treatment could be effective for this condition. It targets proteins involved in the inflammation seen in Crohn's disease. Early findings indicate that PRA023 is generally well tolerated, meaning most patients can take it without many side effects. These initial results offer hope that PRA023 could effectively manage Crohn's disease symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Prometheus Biosciences

Principal Investigator

Clinicaltrials Call Center

Are You a Good Fit for This Trial?

This trial is for adults with Crohn's Disease who have not responded well to standard treatments like corticosteroids or immunosuppressants. Participants should be able to follow the study procedures and use two forms of contraception if they can have children. People with recent bowel surgery, extensive resections, high risk as per investigator's opinion, certain lab criteria, or specific types of colitis are excluded.

Inclusion Criteria

My Crohn's disease is moderate to severe, confirmed by tests.

I rely on corticosteroids or haven't responded well to certain treatments.

Able to provide written informed consent and understand and comply with the requirements of the study

Exclusion Criteria

I have or need a stoma for waste removal.

I agree to use two effective birth control methods during and up to 12 weeks after the study.

I might have an abscess in my abdomen or near my anus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive PRA023 administered by intravenous (IV) infusion to assess safety and efficacy

12 weeks

Regular visits for treatment and monitoring

Open-label extension

Participants have the option to continue receiving PRA023 for further assessment

38 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PRA023

Trial Overview The trial tests PRA023 IV, a new drug for Crohn's Disease. It includes a 12-week induction phase followed by an optional 38-week extension. The goal is to see how safe and effective PRA023 is in managing moderate to severe symptoms compared to previous therapies.

How Is the Trial Designed?

Group I: PRA023 Experimental Treatment 2 Interventions

Participants to receive PRA023 administered by intravenous (IV) infusion.

Who Is Running the Clinical Trial?

Prometheus Biosciences, Inc.

Lead Sponsor

Trials

6

Recruited

600+

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Lead Sponsor

Trials

6

Recruited

600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40456235/

Safety and efficacy of the anti-TL1A monoclonal antibody ... This proof-of-concept study showed that tulisokibart is potentially efficacious in moderately to severely active Crohn's disease and is well tolerated.

2. merck.com merck.com/news/merck-to-present-new-long-term-data-for-tulisokibart-mk-7240-an-investigational-anti-tl1a-monoclonal-antibody-in-inflammatory-bowel-disease-at-ueg-week-2024/

Merck to Present New Long-Term Data for Tulisokibart (MK ... Tulisokibart is now being evaluated in two Phase 3 studies in ulcerative colitis and Crohn's disease. 12-week data from the Phase 2 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06430801

A Study to Evaluate the Efficacy and Safety of Tulisokibart ... The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.

4. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(25)00071-8/abstract

Safety and efficacy of the anti-TL1A monoclonal antibody ... This proof-of-concept study showed that tulisokibart is potentially efficacious in moderately to severely active Crohn's disease and is well ...

5. msdclinicaltrials.com msdclinicaltrials.com/trial/nct06430801/

A Study to Evaluate the Efficacy and Safety of Tulisokibart in ... The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06430801

NCT06430801 | A Study to Evaluate the Efficacy and ... The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468125325000718

Safety and efficacy of the anti-TL1A monoclonal antibody ... This proof-of-concept study showed that tulisokibart is potentially efficacious in moderately to severely active Crohn's disease and is well tolerated.

8. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06430801/

Have you been diagnosed with Crohn's disease? Researchers are testing an investigational study medicine called tulisokibart in people diagnosed with moderately to severely active Crohn's disease (CD).