The trial is taking place at:
H

Hospital Regional Universitario de Malaga | Hospital Civil - Rheumatology Department

Veeva-enabled site

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)

P

Prometheus Biosciences

Status and phase

Enrolling
Phase 2

Conditions

Diffuse Cutaneous Systemic Sclerosis
Interstitial Lung Disease

Treatments

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

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

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)

Trial contacts and locations

74

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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