Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

About

Brief Summary

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Has confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
Has diffuse cutaneous scleroderma
Has systemic sclerosis related interstitial lung disease confirmed by HRCT
FVC ≥ 45% of predicted normal
Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal
If on background therapy, meets stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) OR azathioprine, and corticosteroids
Women of childbearing potential are eligible to participate if not pregnant or breastfeeding and either willing to use an acceptable contraceptive method or sexually abstinent
Able to provide written informed consent and understand and comply with the requirements of the study

Has an airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension
Has current clinical diagnosis of another inflammatory connective tissue disease
Has any active infections, a serious infection within the past 3 months, or chronic bacterial infection
Is a current smoker or smoking within 6 months of screening
Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study