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)
- Conditions
- Diffuse Cutaneous Systemic SclerosisInterstitial Lung Disease
- Interventions
- Drug: TulisokibartDiagnostic Test: Companion diagnostic ( CDx)Drug: Placebo
- Registration Number
- NCT05270668
- Lead Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Brief Summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 152
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tulisokibart Tulisokibart Tulisokibart IV administered by IV infusion Tulisokibart Companion diagnostic ( CDx) Tulisokibart IV administered by IV infusion Placebo Companion diagnostic ( CDx) Placebo administered by IV infusion Placebo Placebo Placebo administered by IV infusion
- Primary Outcome Measures
Name Time Method 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 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.
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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in FVC at Week 50 Baseline and 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.
Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50 Baseline and Week 50 QILD-WL will be measured as percent lung involvement using HRCT.
Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at Week 50 Baseline and Week 50 The Revised CRISS is a two-step process designed to evaluate the likelihood of improvement in early SSc. The first step assesses worsening or incident cases of internal organ involvement (scleroderma renal crisis, pulmonary arterial hypertension, congestive heart failure, ILD, severe gastrointestinal dysmotility requiring parenteral or enteral nutrition, and digital ischemia requiring hospitalization, gangrene, or amputation). The second step assesses changes from baseline in five core set measures: modified Rodnan skin score (mRSS), percent predicted forced vital capacity (FVC%), health assessment questionnaire-disability index (HAQ-DI), patient (PGA), and physician (PhGA) global assessments.
Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50 Baseline and Week 50 HAQ is an instrument to assess physical function. It consists of 20 questions, covering eight types of activities. For each question, scores range from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty or with assistance; 3 = unable to do). HAQ Disability Index (HAQ-DI) score is the average of the highest score in each of the eight categories.
Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at Week 50 Baseline and Week 50 The L-PF is a questionnaire designed to assess the quality of life of patients with pulmonary fibrosis. It contains 44 questions (items) split into two modules, 23 which assess symptoms (including shortness of breath, cough, and fatigue) and 21 which assess impacts to quality of life. Individual items are scored on a 5-point scale (0 = Not at All to 4 = Extremely). Overall scores range from 0 to 100 with higher scores indicating a greater impairment.
Trial Locations
- Locations (86)
Budai Irgalmasrendi Korhaz ( Site 4252)
🇭🇺Budapest, Hungary
Consultorios Médicos Dr. Doreski ( Site 4800)
🇦🇷Caba, Buenos Aires, Argentina
Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)
🇦🇷Rosario, Santa Fe, Argentina
Kyiv City Clinical Hospital # 3 ( Site 4754)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Medical Center OK!Clinic+LLC International Institute of Clinical Research ( Site 4753)
🇺🇦Kyiv, Ukraine
Institute of Rheumatology LLC ( Site 4752)
🇺🇦Kyiv, Ukraine
Mayo Clinic - Scottsdale ( Site 4014)
🇺🇸Phoenix, Arizona, United States
Pacific Arthritis Care Center ( Site 4008)
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center ( Site 4010)
🇺🇸Los Angeles, California, United States
UCLA School of Medicine ( Site 4006)
🇺🇸Los Angeles, California, United States
Stanford Health Care ( Site 4009)
🇺🇸Palo Alto, California, United States
National Jewish Health Medical Center ( Site 4015)
🇺🇸Denver, Colorado, United States
Yale University ( Site 4017)
🇺🇸New Haven, Connecticut, United States
MedStar Georgetown University Hospital ( Site 4005)
🇺🇸Washington, District of Columbia, United States
Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital ( Site 4003)
🇺🇸Boston, Massachusetts, United States
Boston University School of Medicine ( Site 4021)
🇺🇸Boston, Massachusetts, United States
University of Michigan Hospital ( Site 4001)
🇺🇸Ann Arbor, Michigan, United States
Rutgers Robert Wood Johnson Medical School ( Site 4013)
🇺🇸New Brunswick, New Jersey, United States
Hospital For Special Surgery ( Site 4020)
🇺🇸New York, New York, United States
Cleveland Clinic Foundation ( Site 4019)
🇺🇸Cleveland, Ohio, United States
University of Toledo Medical Center ( Site 4002)
🇺🇸Toledo, Ohio, United States
University of Pittsburgh Medical Center ( Site 4016)
🇺🇸Pittsburgh, Pennsylvania, United States
Pecsi Tudomanyegyetem AOK ( Site 4250)
🇭🇺Pecs, Baranya, Hungary
Medical University of South Carolina - PPDS ( Site 4004)
🇺🇸Charleston, South Carolina, United States
UT Physicians Rheumatology ( Site 4007)
🇺🇸Houston, Texas, United States
Froedtert and Medical College of Wisconsin ( Site 4012)
🇺🇸Milwaukee, Wisconsin, United States
Royal Adelaide Hospital ( Site 4050)
🇦🇺Adelaide, South Australia, Australia
St Vincents Hospital Melbourne ( Site 4051)
🇦🇺Melbourne, Victoria, Australia
CHU de Liege ( Site 4400)
🇧🇪Liège, Liege, Belgium
UZ Gent ( Site 4401)
🇧🇪Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 4402)
🇧🇪Leuven, Vlaams-Brabant, Belgium
University Of Alberta Hospital ( Site 4702)
🇨🇦Edmonton, Alberta, Canada
St. Joseph's Health Care London ( Site 4701)
🇨🇦London, Ontario, Canada
Mount Sinai Hospital [Toronto, Canada] ( Site 4700)
🇨🇦Toronto, Ontario, Canada
Centro de especialidades médicas Vanguardia ( Site 4850)
🇨🇱Temuco, Araucania, Chile
BIOCINETIC Ltda ( Site 4854)
🇨🇱Santiago, Region M. De Santiago, Chile
Centro Internacional de Estudios Clinicos CIEC ( Site 4851)
🇨🇱Santiago, Region M. De Santiago, Chile
Clinica Dermacross ( Site 4853)
🇨🇱Vitacura, Region M. De Santiago, Chile
CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
🇫🇷Bordeaux, Nord, France
Hôpital Claude Huriez ( Site 4200)
🇫🇷Lille, Nord, France
Hopital Cochin ( Site 4203)
🇫🇷Paris, France
Universitaetsklinikum Freiburg ( Site 4152)
🇩🇪Freiburg, Baden-Wurttemberg, Germany
Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)
🇩🇪Bad Nauheim, Hessen, Germany
Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)
🇩🇪Hohenfelde B Bad Doberan, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Koeln ( Site 4151)
🇩🇪Köln, Nordrhein-Westfalen, Germany
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 4251)
🇭🇺Debrecen, Hungary
Rambam Medical Center ( Site 4601)
🇮🇱Haifa, Israel
Meir Medical Center. ( Site 4604)
🇮🇱Kfar Saba, Israel
Galilee Medical Center ( Site 4602)
🇮🇱Nahariya, Israel
Rabin Medical Center ( Site 4603)
🇮🇱Petach Tikvah, Israel
Sheba Medical Center ( Site 4605)
🇮🇱Ramat-Gan, Israel
Tel Aviv Sourasky Medical Center ( Site 4606)
🇮🇱Tel Aviv, Israel
Fondazione IRCCS Policlinico San Matteo ( Site 4303)
🇮🇹Pavia, Lombardia, Italy
A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)
🇮🇹Torino, Piemonte, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 4301)
🇮🇹Firenze, Italy
Ospedale Policlinico San Martino ( Site 4305)
🇮🇹Genova, Italy
IRCCS Osp. Maggiore Policlinico ( Site 4306)
🇮🇹Milano, Italy
Ospedale San Raffaele di Milano ( Site 4307)
🇮🇹Milano, Italy
Arcispedale Santa Maria Nuova ( Site 4300)
🇮🇹Reggio Emilia, Italy
Azienda Policlinico Umberto I ( Site 4302)
🇮🇹Roma, Italy
Radboud University Medical Center ( Site 4650)
🇳🇱Nijmegen, Gelderland, Netherlands
Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
🇳🇴Oslo, Norway
Centrum Medyczne Oporow ( Site 4455)
🇵🇱Wroclaw, Dolnoslaskie, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Centrum Medyczne Reuma Park NZOZ ( Site 4450)
🇵🇱Warszawa, Mazowieckie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)
🇵🇱Białystok, Podlaskie, Poland
Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)
🇵🇱Bytom, Slaskie, Poland
Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
🇵🇱Poznań, Wielkopolskie, Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site
🇵🇱Warszawa, Wielkopolskie, Poland
Hospital Central de Asturias ( Site 4109)
🇪🇸Oviedo, Asturias, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
🇪🇸Barcelona, Cataluna, Spain
Hospital Universitario 12 de Octubre ( Site 4106)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)
🇪🇸Barcelona, Spain
Hospital Santa Creu i Sant Pau ( Site 4102)
🇪🇸Barcelona, Spain
Hospital Universitario Ramon y Cajal ( Site 4101)
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga ( Site 4104)
🇪🇸Malaga, Spain
Hospital Universitario Doctor Peset ( Site 4103)
🇪🇸Valencia, Spain
Hospital Clinico Universitario Lozano Blesa ( Site 4100)
🇪🇸Zaragoza, Spain
Inselspital Bern ( Site 4502)
🇨🇭Bern, Berne, Switzerland
Kantonsspital St. Gallen ( Site 4501)
🇨🇭St. Gallen, Sankt Gallen, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 4503)
🇨🇭Geneve, Switzerland
Universitaetsspital Zuerich ( Site 4500)
🇨🇭Zurich, Switzerland
Royal Free Hospital ( Site 4550)
🇬🇧London, London, City Of, United Kingdom
Chapel Allerton Hospital ( Site 4551)
🇬🇧Leeds, United Kingdom