The ATHENA-SSc-ILD Study
Research type
Research Study
Full title
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)
IRAS ID
1005062
Contact name
Michelle Mazzoni
Contact email
Sponsor organisation
Prometheus Biosciences, Inc.
Eudract number
2021-005206-10
Clinicaltrials.gov Identifier
Research summary
Systemic Sclerosis (scleroderma, SSc) is an autoimmune disease in which the body’s immune system stimulates scarring of the skin and internal organs including the lungs. Scleroderma associated Interstitial Lung Disease (ILD) affects more than half of patients and is a leading cause of disability and death. \n\nThe available treatments for scleroderma associated ILD have been shown to slow the loss of lung function but do not improve shortness of breath, quality of life and function nor do they appear to improve other aspects of SSc. \n\nThe purpose of this study is to obtain information on the safety and efficacy of a drug called PRA023 compared with a placebo (dummy drug) in adult participants, 18 years and above, with SSc-ILD. \n\nParticipants who meet all eligibility criteria will be randomised to receive either study drug (PRA023) or placebo for the 50 week treatment period. The chance of receiving either study drug or placebo is the same. After the treatment period the data will be analysed and if the results are favourable patients who completed the 50 week treatment period will have an option to receive PRA023 in the open-label-extension (OLE) period.\n\nThe study consists of screening assessments, a 50 week treatment period (up to 17 study visits), an optional OLE period and a follow-up period (3 study visits). Assessments include physical examinations, vital signs, high resolution computerised tomography (HRCT) of the lungs, electrocardiograms (ECGs), pulmonary function tests, blood and urine sample collection for testing, completion of quality of life questionnaires, and optional skin biopsy collection. The total study duration will be up to 116 weeks.\n\nApproximately 100 adult participants will participate worldwide with approximately 4 patients from 2 hospitals in the UK. The Sponsor of this study is Prometheus Biosciences, Inc..
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0195
Date of REC Opinion
19 Jul 2022
REC opinion
Further Information Favourable Opinion