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Monoclonal Antibodies

PRA023 for Ulcerative Colitis (ARTEMIS-UC Trial)

Phase 2

Waitlist Available

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

Eligibility Criteria Checklist

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

Must have

Confirmed diagnosis of ulcerative colitis (UC)

Moderately to severely active UC as defined by 3-component Modified Mayo score

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

ARTEMIS-UC Trial Summary

This trial is testing a potential new Ulcerative Colitis treatment, PRA023. It will assess how safe and effective it is in people with moderate to severe Ulcerative Colitis.

Who is the study for?

This trial is for people with moderate to severe Ulcerative Colitis who haven't responded well to, or can't tolerate, certain UC treatments like steroids or immunosuppressants. Participants must have a confirmed diagnosis and be able to follow the study's procedures. Those with Crohn's disease, at high risk per investigator's opinion, or unable/unwilling to use effective contraception are excluded.Check my eligibility

What is being tested?

The trial is testing PRA023 in two ways: directly through IV administration and by assessing its safety and effectiveness in those who test positive on companion diagnostic tests. After an initial 12-week period, participants can choose to continue treatment for another 38 weeks.See study design

What are the potential side effects?

While specific side effects of PRA023 aren't listed here, common ones for similar drugs include infusion reactions (like pain or discomfort at the injection site), gastrointestinal symptoms (nausea, diarrhea), potential liver issues, and increased infection risk.

ARTEMIS-UC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with ulcerative colitis.

Select...

My ulcerative colitis is moderate to severe.

ARTEMIS-UC 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

Induction of clinical remission

Safety and tolerability

Secondary outcome measures

Change in IBDQ

Change in IBDQ in CDx+ participants

Clinical remission in CDx+ vs. CDx- participants

+12 more

ARTEMIS-UC Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 1 PRA023Experimental Treatment1 Intervention

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

Group II: CDx+ Expansion Cohort PRA023Experimental Treatment2 Interventions

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

Group III: Cohort 1 PlaceboPlacebo Group1 Intervention

Participant randomized to receive placebo administered by intravenous (IV) infusion.

Group IV: CDx+ Expansion Cohort PlaceboPlacebo Group2 Interventions

Participant randomized to receive placebo administered by intravenous (IV) infusion.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

5 Previous Clinical Trials

421 Total Patients Enrolled

Prometheus Biosciences, Inc.Lead Sponsor

5 Previous Clinical Trials

421 Total Patients Enrolled

Prometheus BiosciencesStudy DirectorClinicaltrials Call center

3 Previous Clinical Trials

256 Total Patients Enrolled

Media Library

PRA023 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04996797 — Phase 2

Ulcerative Colitis Research Study Groups: Cohort 1 PRA023, Cohort 1 Placebo, CDx+ Expansion Cohort PRA023, CDx+ Expansion Cohort Placebo

Ulcerative Colitis Clinical Trial 2023: PRA023 Highlights & Side Effects. Trial Name: NCT04996797 — Phase 2

PRA023 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04996797 — Phase 2

Frequently Asked Questions

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

Are people still being accepted into this experiment?

"This clinical trial is actively recruiting patients, as indicated on the website clinicaltrials.gov. The listing for this study was first posted on July 14th, 2021 and last updated on May 23rd, 2022."

Answered by AI

What goals does this research hope to achieve?

"The primary goal of this study, to be completed within 12 weeks, is to evaluate the safety and tolerability of the medication. Additionally, researchers will investigate if the drug has an effect on CDx+ participants achieving clinical remission, mucosal healing, and histologic remission."

Answered by AI

Is there any danger associated with CDx Testing?

"While there is some data supporting the safety of CDx Testing, it falls into Phase 2 of clinical trials and thus has not yet been proven effective."

Answered by AI

In how many different medical facilities is this research project being conducted?

"34 different hospitals and clinics are participating in this study, with locations in cities such as San Antonio, Charlottesville, Garland, among others. To cut down on participant travel time, it is recommended to select the clinical trial site nearest you."

Answered by AI

How many people are joining this clinical trial?

"That is correct. The study, which was originally posted on July 14th 2021 and edited most recently on May 23rd 2022, is still looking for 170 participants at 34 different enrolment locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

2021. "A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04996797.

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