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) (ATHENA-SSc-ILD)

Prometheus Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Diffuse Cutaneous Systemic Sclerosis; Interstitial Lung Disease

Treatments: Diagnostic Test: Companion diagnostic ( CDx); Drug: Tulisokibart; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05270668

2021-005206-10 (EudraCT Number)

7240-007

PR200-104

MK-7240-007 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Meets the protocol criteria for important laboratory exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 2 patient groups, including a placebo group

Tulisokibart

Experimental group

Description:

Tulisokibart IV administered by IV infusion

Treatment:

Drug: Tulisokibart

Diagnostic Test: Companion diagnostic ( CDx)

Placebo

Placebo Comparator group

Description:

Placebo administered by IV infusion

Treatment:

Drug: Placebo

Diagnostic Test: Companion diagnostic ( CDx)