PRA023 IV for Diffuse Scleroderma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diffuse Scleroderma+6 More
PRA023 IV - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Diffuse Scleroderma
  • Lung Diseases, Interstitial

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Week 50

Week 50
Annual change of forced vital capacity (FVC)
Annual rate of change in percent predicted FVC
Change in American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS)
Change in high-resolution computer tomography (HRCT)
Change of FVC
Incidence of AE, SAE and AE leading to discontinuation

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

PRA023
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: PRA023 IV · Has Placebo Group · Phase 2

PRA023Experimental Group · 2 Interventions: PRA023 IV, Companion diagnostic ( CDx) · Intervention Types: Drug, Device
PlaceboPlaceboComparator Group · 2 Interventions: Placebo, Companion diagnostic ( CDx) · Intervention Types: Drug, Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 50

Who is running the clinical trial?

Prometheus Biosciences, Inc.Lead Sponsor
5 Previous Clinical Trials
442 Total Patients Enrolled
Prometheus BiosciencesStudy DirectorClinical Trials Call Center
3 Previous Clinical Trials
269 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have diffuse cutaneous scleroderma.
You are able to provide written informed consent and understand and comply with the requirements of the study.
DLCO must be ≥ 45% of predicted normal.
You are taking MMF, MTX or AZA at the same time as corticosteroids.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.