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)

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/09/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vivek Nagaraja, M.D.

Open for enrollment

Contact information:

Bianca Montelongo

(480) 301-4665

Montelongo.Bianca@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20540044

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