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Monoclonal Antibodies

PRA023 for Systemic Sclerosis-Associated ILD (ATHENA-SSc-ILD Trial)

Phase 2

Recruiting

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

Has diffuse cutaneous scleroderma

Has systemic sclerosis related interstitial lung disease confirmed by HRCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 50

Awards & highlights

ATHENA-SSc-ILD Trial Summary

This trial is testing a new drug to see if it's safe and effective for people with a lung disease called SSc-ILD.

Who is the study for?

This trial is for people with systemic sclerosis that started within the last 5 years and associated lung disease, who are not current smokers. They must have a certain level of lung function and be on stable medication doses. Participants need to use effective contraception and cannot join if they have other inflammatory diseases, serious recent infections, or significant heart or lung complications.Check my eligibility

What is being tested?

The study tests PRA023's safety and effectiveness in treating systemic sclerosis-related lung disease compared to a placebo. A companion diagnostic tool is also used. The goal is to see if PRA023 can help manage this condition better than existing treatments.See study design

What are the potential side effects?

While specific side effects for PRA023 aren't listed here, similar medications may cause immune system reactions, infusion-related discomforts, fatigue, digestive issues like nausea or diarrhea, skin reactions at injection sites, and increased risk of infections.

ATHENA-SSc-ILD Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with diffuse cutaneous scleroderma.

Select...

I have lung disease related to systemic sclerosis confirmed by a special lung scan.

ATHENA-SSc-ILD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 50

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 50

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 50 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50

Number of Participants who Discontinue due to an AE

Number of Participants who Experience a Serious Adverse Event (SAE)

+1 more

Secondary outcome measures

Change from Baseline in FVC at Week 50

Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50

Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50

+2 more

ATHENA-SSc-ILD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TulisokibartExperimental Treatment2 Interventions

Tulisokibart IV administered by IV infusion

Group II: PlaceboPlacebo Group2 Interventions

Placebo administered by 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

447 Total Patients Enrolled

Prometheus Biosciences, Inc.Lead Sponsor

5 Previous Clinical Trials

447 Total Patients Enrolled

Prometheus BiosciencesStudy DirectorClinical Trials Call Center

3 Previous Clinical Trials

282 Total Patients Enrolled

Media Library

PRA023 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05270668 — Phase 2

Systemic Sclerosis Research Study Groups: Tulisokibart, Placebo

Systemic Sclerosis Clinical Trial 2023: PRA023 Highlights & Side Effects. Trial Name: NCT05270668 — Phase 2

PRA023 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05270668 — Phase 2

Frequently Asked Questions

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

At how many different hospitals can patients enroll in this trial?

"At the moment, this research is enrolling people from 9 different locations. These sites are situated in Boston, Denver, New Brunswick and 6 other cities. If you want to reduce travel as much as possible, it would be best to select a clinic near your home."

Answered by AI

Can people with certain medical conditions join this trial?

"The study, which is currently seeking participants, was originally posted on February 22nd, 2022. The information available on clinicaltrials.gov has been edited most recently on November 4th, 2022."

Answered by AI

What is the status of PRA023's FDA approval process for intravenous use?

"PRA023 IV is in Phase 2 of clinical trials, so there is only data supporting safety at this time."

Answered by AI

What hypotheses does this research aim to verify?

"The aim of this study, which will be completed and evaluated over the course of 50 weeks, is to track the incidence of adverse events (AE), serious adverse events (SAE), and discontinuations due to AE. Additionally, researchers will secondary outcomes including changes in American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS) – defined as the proportion of subjects with improvement of ACR CRISS – change in high-resolution computer tomography (HRCT) quantitative ILD, and annual rate of change in percent predicted forced vital capacity (FVC)."

Answered by AI

How many total individuals are participating in this experiment?

"The information available on clinicaltrials.gov does appear to show that this trial is looking for more participants as of right now. This particular study was first posted on February 22nd, 2022 and has been updated as recently as November 4th, 2022. They are specifically searching for 100 individuals who meet the criteria at 9 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

2022. "Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05270668.

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