PRA023 for Crohn's Disease
(APOLLO-CD Trial)

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Prometheus Biosciences, Inc.

No Placebo Group

Prior Safety Data

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.

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

+1 more

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.

+7 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: PRA023Experimental Treatment2 Interventions

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