PRA023 for Crohn's Disease

(APOLLO-CD Trial)

Recruiting at 37 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

55 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called PRA023 for people with moderately to severely active Crohn's Disease. The medication aims to reduce inflammation in the digestive tract, which should help relieve symptoms like pain and diarrhea. Participants will initially take the medication for a few months and may choose to continue for several more months.

Research Team

Prometheus Biosciences

Principal Investigator

Clinicaltrials Call Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+