A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/ PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)

Phase 2

Conditions: Systemic Sclerosis en Interstitial Lung Disease
10003816

Registration Number: NL-OMON53698

Lead Sponsor: Prometheus Biosciences, Inc, a subsidiary of Merck & Co.,Inc.(Rahway,NJ,USA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 5

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

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>x The proportion of subjects reporting adverse events (AEs), serious adverse<br /><br>events<br /><br>(SAEs), AEs leading to discontinuation, and markedly abnormal laboratory<br /><br>values<br /><br>x To compare the annual rate of change from Baseline in FVC, in mL, of<br /><br>MK-7240/PRA023 vs. placebo over 50 weeks </p><br>

Secondary Outcome Measures