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

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD). - The ATHENA-SSc-ILD Study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005206-10-ES

Enrollment

100

Registered

2022-02-02

Start date

2022-04-12

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic sclerosis associated with interstitial lung disease. MedDRA version: 21.0 Level: LLT Classification code 10025109 Term: Lung involvement in systemic sclerosis System Organ Class: 100000004855

Interventions

Product Code: PRA023 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Not yet assigned Current Sponsor code: PRA023 Other descriptive name: PRA023 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of systemic sclerosis with onset of disease 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To assess the safety and tolerability of PRA023 in SSc-ILD. • 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. • To compare the change from Baseline in high-resolution computer tomography (HRCT) at Week 50. • To compare the annual rate of change in percent predicted FVC. • 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. _ To compare the annual rate of change from Baseline in FVC.;Timepoint(s) of evaluation of this end point: Week 50.	—

Measure

Time frame

Main Objective: • To assess the safety and tolerability of PRA023 in SSc-ILD. • 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. • To compare the change from Baseline in high-resolution computer tomography (HRCT) at Week 50. • To compare the annual rate of change in percent predicted FVC. • 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. _ To compare the annual rate of change from Baseline in FVC.;Timepoint(s) of evaluation of this end point: Week 50.

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Secondary

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

Countries

Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactClinical Operations

Prometheus Biosciences, Inc.

RegistroEspanolDeEstudiosClinicos@druginfo.com+34900834223

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026