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Monoclonal Antibodies

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

Phase 2

Waitlist Available

Research Sponsored by Prometheus Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy

Confirmed diagnosis of Crohn's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

APOLLO-CD Trial Summary

This trial is testing a new drug for Crohn's Disease to see if it is safe and effective. Participants will take the drug for 12 weeks and then can choose to continue taking it for an additional 38 weeks.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the specific side effects of PRA023 are not listed here, similar drugs often cause immune system reactions, infusion-related discomforts, potential infections due to lowered immunity, gastrointestinal issues and possible allergic responses.

APOLLO-CD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

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I have been diagnosed with Crohn's disease.

APOLLO-CD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Adverse Events Leading to Discontinuation

Endoscopic Improvement

+1 more

Secondary outcome measures

Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)

Clinical Remission

Clinical Response

+8 more

Other outcome measures

Endoscopic Improvement and clinical remission by companion diagnostic (CDx) status

APOLLO-CD Trial Design

1Treatment groups

Experimental Treatment

Group I: PRA023Experimental Treatment2 Interventions

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Prometheus Biosciences, Inc.Lead Sponsor

5 Previous Clinical Trials

544 Total Patients Enrolled

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

5 Previous Clinical Trials

544 Total Patients Enrolled

Prometheus BiosciencesStudy DirectorClinicaltrials Call Center

3 Previous Clinical Trials

379 Total Patients Enrolled

Media Library

PRA023 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05013905 — Phase 2

Crohn's Disease Research Study Groups: PRA023

Crohn's Disease Clinical Trial 2023: PRA023 Highlights & Side Effects. Trial Name: NCT05013905 — Phase 2

PRA023 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05013905 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability to join this scientific research?

"According to the information on clinicaltrials.gov, this particular trial is not recruiting at present; it was initially posted July 28th 2021 and revised August 10th 2022. Despite that, there are over 250 other medical trials seeking participants as we speak."

Answered by AI

What outcomes is this research endeavor attempting to realize?

"This trial aims to measure endoscopic improvement at Week 12, with secondary objectives including PRO-2 remission rates, SES-CD assessment changes and the proportion of patients achieving clinical remission."

Answered by AI

Are there any venues other than this location where the trial is being conducted in the state?

"This medical trial is currently actively recruiting from 16 different sites, distributed across Halifax, San Antonio and Chesterfield among other cities. Prospective participants should consider choosing the closest location to them in order to reduce any travel-related complications that may arise while enrolled."

Answered by AI

Has the FDA accepted Companion diagnostic (CDx) as a safe and effective medical tool?

"Our team at Power has assessed the safety of Companion Diagnostics (CDx) to be a 2 due to its Phase 2 status, with partial evidence for safety but no proof confirming efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

2021. "A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05013905.

All > Crohns Disease