Clinical Trials in France / NCT05270668
Active, not recruiting
Phase 2
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)
NCT05270668 · tracked via the Priya Life Science France tracker
Condition(s) studied
Diffuse Cutaneous Systemic SclerosisInterstitial Lung Disease
Investigational drug(s) / intervention(s)
Tulisokibart: Tulisokibart administered at timepoints as directed by the protocol
Companion diagnostic ( CDx): CDx+ or CDx-
Placebo: Placebo
Study summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Eligibility
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
Primary outcome measure(s)
- Number of Participants who Experience an Adverse Event (AE) — Up to Week 50
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an AE will be reported. - Number of Participants who Experience a Serious Adverse Event (SAE) — Up to Week 50
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an SAE will be reported. - Number of Participants who Discontinue due to an AE — Up to Week 50
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who discontinue due to an AE will be reported. - Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50 — Baseline and up to Week 50
FVC, as measured in milliliters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible.
Trial sites (95)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic - Scottsdale ( Site 4014) | Phoenix | Arizona | |
| Pacific Arthritis Care Center ( Site 4008) | Los Angeles | California | |
| Cedars Sinai Medical Center ( Site 4010) | Los Angeles | California | |
| UCLA School of Medicine ( Site 4006) | Los Angeles | California | |
| Stanford Health Care ( Site 4009) | Palo Alto | California | |
| National Jewish Health Medical Center ( Site 4015) | Denver | Colorado | |
| Yale University ( Site 4017) | New Haven | Connecticut | |
| MedStar Georgetown University Hospital ( Site 4005) | Washington D.C. | District of Columbia | |
| Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018) | Baltimore | Maryland | |
| Massachusetts General Hospital ( Site 4003) | Boston | Massachusetts | |
| Boston University School of Medicine ( Site 4021) | Boston | Massachusetts | |
| University of Michigan Hospital ( Site 4001) | Ann Arbor | Michigan | |
| Rutgers Robert Wood Johnson Medical School ( Site 4013) | New Brunswick | New Jersey | |
| Hospital For Special Surgery ( Site 4020) | New York | New York | |
| Cleveland Clinic Foundation ( Site 4019) | Cleveland | Ohio | |
| University of Toledo Medical Center ( Site 4002) | Toledo | Ohio | |
| University of Pittsburgh Medical Center ( Site 4016) | Pittsburgh | Pennsylvania | |
| Medical University of South Carolina - PPDS ( Site 4004) | Charleston | South Carolina | |
| UT Physicians Rheumatology ( Site 4007) | Houston | Texas | |
| Froedtert and Medical College of Wisconsin ( Site 4012) | Milwaukee | Wisconsin | |
| Consultorios Médicos Dr. Doreski ( Site 4800) | CABA | Buenos Aires | |
| Clínica Privada Independencia ( Site 4802) | Munro | Buenos Aires | |
| Centro de Investigación Instituto Médico Río Cuarto ( Site 4801) | Río Cuarto | Córdoba Province | |
| Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803) | Rosario | Santa Fe Province | |
| Royal Adelaide Hospital ( Site 4050) | Adelaide | South Australia | |
| St Vincents Hospital Melbourne ( Site 4051) | Melbourne | Victoria | |
| UZ Gent ( Site 4401) | Ghent | Oost-Vlaanderen | |
| UZ Leuven ( Site 4402) | Leuven | Vlaams-Brabant | |
| CHU de Liege ( Site 4400) | Liège | Wallonne, Region | |
| University Of Alberta Hospital ( Site 4702) | Edmonton | Alberta | |
| St. Joseph's Health Care London ( Site 4701) | London | Ontario | |
| Mount Sinai Hospital [Toronto, Canada] ( Site 4700) | Toronto | Ontario | |
| Centro de especialidades médicas Vanguardia ( Site 4850) | Temuco | Araucania | |
| BIOCINETIC Ltda ( Site 4854) | Santiago | Region M. de Santiago | |
| Centro de Investigacion Clinica UC CICUC ( Site 4855) | Santiago | Region M. de Santiago | |
| Centro Internacional de Estudios Clinicos CIEC ( Site 4851) | Santiago | Region M. de Santiago | |
| Clinica Dermacross ( Site 4853) | Vitacura | Region M. de Santiago | |
| ONCOCENTRO APYS ( Site 4852) | Viña del Mar | Valparaiso | |
| CHU de Bordeaux. Hopital Pellegrin ( Site 4202) | Bordeaux | Nord | |
| Hôpital Claude Huriez ( Site 4200) | Lille | Nord |
+ 55 more sites — see the full list on the official registry below.
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05270668 on ClinicalTrials.gov ↗ ← All trials in France