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)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05270668
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Prometheus Biosciences
Principal Investigator Affiliation	Clinical Trials Call Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Tulisokibart

Tulisokibart IV administered by IV infusion

Placebo Comparator: Placebo

Placebo administered by IV infusion

Interventions

Drug: - Tulisokibart

Tulisokibart administered at timepoints as directed by the protocol

Diagnostic Test: - Companion diagnostic ( CDx)

CDx+ or CDx-

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic - Scottsdale ( Site 4014), Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic - Scottsdale ( Site 4014)

Phoenix, Arizona, 85054

Site Contact

Study Coordinator

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