A study of PRA023 in patients with Systemic Sclerosis Associated with Interstitial Lung Disease.

Phase 1

• Conditions: Systemic sclerosis associated with interstitial lung disease.; MedDRA version: 21.0Level: LLTClassification code 10025109Term: Lung involvement in systemic sclerosisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-005206-10-ES
• Lead Sponsor: Prometheus Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-02
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Confirmed diagnosis of systemic sclerosis with onset of disease < or = 5 years ago.
2. Diffuse cutaneous scleroderma.
3. Systemic sclerosis related to interstitial lung disease confirmed by HRCT.
4. FVC > or = 45% of predicted normal.
5. Diffusing capacity of lung for carbon monoxide (DLCO) > or = 45% of predicted normal.
6. Stable dosing of myocphenolate mofetil (MMF), methotrexate (MTX) or azathioprine, as well as corticosteroids.
7. Able to provide written informed consent and understand and comply with the requirements of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. WOCBP and men with female partners of childbearing potential who are unwilling or unable to use tow highly effective methods of contraception to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of study drug.
2. Airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension.
3. Current clinical diagnosis of another inflammatory connective tissue disease.
4. Any active infections, a serious infection within the past 3 months, or chronic bacterial infection.
5. Current smoker or smoking within 6 months of screening.
6. Subjects in the opinion of the investigator that are at an unacceptable risk for participation in the study.
7. Subjects who meet the protocol criteria for important laboratory exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To assess the safety and tolerability of PRA023 in SSc-ILD. <br>• To compare the annual rate of change from Baseline in forced vital capacity (FVC), of PRA023 vs. placebo over 50 weeks.;Secondary Objective: • To compare the change from Baseline in FVC at Week 50. <br>• To compare the change from Baseline in high-resolution computer tomography (HRCT) at Week 50. <br>• To compare the annual rate of change in percent predicted FVC. <br>• To compare proportion of subjects with an improvement in the American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS) score at Week 50.;Primary end point(s): _ The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values. <br>_ To compare the annual rate of change from Baseline in FVC.;Timepoint(s) of evaluation of this end point: Week 50.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): _To compare the change from Baseline in FVC.<br>_To compare the annual rate of change in percent predicted FVC. <br>_To compare the change from Baseline in HRCT.<br>_To compare proportion of subjects with an improvement of the ACR CRISS score.;Timepoint(s) of evaluation of this end point: Week 50.