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)

Interstitial Lung Disease Clinical Trial

— ATHENA-SSc-ILD  

Official title:

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270668
• Other study ID #: 7240-007
• Secondary ID: PR200-104MK-7240
• Status: Recruiting
• Phase: Phase 2
• Start date: July 13, 2022
• Est. completion date: December 30, 2028

Study information

• Verified date: May 2024
• Source: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: December 30, 2028
• Est. primary completion date: December 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Diffuse Cutaneous Systemic Sclerosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Drug:
• Tulisokibart
Tulisokibart administered at timepoints as directed by the protocol

Diagnostic Test:
• Companion diagnostic ( CDx)
CDx+ or CDx-

Drug:
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital ( Site 4050)	Adelaide	South Australia
Australia	St Vincents Hospital Melbourne ( Site 4051)	Melbourne	Victoria
Belgium	UZ Gent ( Site 4401)	Gent	Oost-Vlaanderen
Belgium	UZ Leuven ( Site 4402)	Leuven	Vlaams-Brabant
Belgium	CHU de Liege ( Site 4400)	Liege
Canada	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
France	CHU de Bordeaux. Hopital Pellegrin ( Site 4202)	Bordeaux	Nord
France	Hôpital Claude Huriez ( Site 4200)	Lille	Nord
France	Hopital Cochin ( Site 4203)	Paris
Germany	Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)	Bad Nauheim	Hessen
Germany	Universitaetsklinikum Freiburg ( Site 4152)	Freiburg	Baden-Wurttemberg
Germany	Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)	Hohenfelde B Bad Doberan	Mecklenburg-Vorpommern
Germany	Universitaetsklinikum Koeln ( Site 4151)	Köln	Nordrhein-Westfalen
Hungary	Budai Irgalmasrendi Korhaz ( Site 4252)	Budapest
Hungary	Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont ( Site 4251)	Debrecen
Hungary	Pecsi Tudomanyegyetem AOK ( Site 4250)	Pecs	Baranya
Israel	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
Italy	Azienda Ospedaliera Universitaria Careggi ( Site 4301)	Firenze
Italy	Ospedale Policlinico San Martino ( Site 4305)	Genova
Italy	Fondazione IRCCS Policlinico San Matteo ( Site 4303)	Pavia	Lombardia
Italy	Arcispedale Santa Maria Nuova ( Site 4300)	Reggio Emilia
Italy	Azienda Policlinico Umberto I ( Site 4302)	Roma
Italy	A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)	Torino	Piemonte
Netherlands	Radboud University Medical Center ( Site 4650)	Nijmegen	Gelderland
Norway	Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)	Oslo
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)	Bydgoszcz	Kujawsko-pomorskie
Poland	Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)	Bytom	Slaskie
Poland	Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)	Poznan	Wielkopolskie
Poland	Centrum Medyczne Reuma Park NZOZ ( Site 4450)	Warszawa	Mazowieckie
Poland	Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site	Warszawa	Wielkopolskie
Poland	Centrum Medyczne Oporow ( Site 4455)	Wroclaw	Dolnoslaskie
Spain	HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)	Barcelona	Cataluna
Spain	Hospital Santa Creu i Sant Pau ( Site 4102)	Barcelona
Spain	Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)	Barcelona
Spain	Hospital Universitario 12 de Octubre ( Site 4106)	Madrid
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
Switzerland	Inselspital Bern ( Site 4502)	Bern	Berne
Switzerland	Hopitaux Universitaires de Geneve HUG ( Site 4503)	Geneve
Switzerland	Kantonsspital St. Gallen ( Site 4501)	St. Gallen	Sankt Gallen
Switzerland	Universitaetsspital Zuerich ( Site 4500)	Zurich
United Kingdom	Chapel Allerton Hospital ( Site 4551)	Leeds
United Kingdom	Royal Free Hospital ( Site 4550)	London	London, City Of
United States	University of Michigan Hospital ( Site 4001)	Ann Arbor	Michigan
United States	Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)	Baltimore	Maryland
United States	Boston University School of Medicine ( Site 4021)	Boston	Massachusetts
United States	Massachusetts General Hospital ( Site 4003)	Boston	Massachusetts
United States	Medical University of South Carolina - PPDS ( Site 4004)	Charleston	South Carolina
United States	Cleveland Clinic Foundation ( Site 4019)	Cleveland	Ohio
United States	National Jewish Health Medical Center ( Site 4015)	Denver	Colorado
United States	UT Physicians Rheumatology ( Site 4007)	Houston	Texas
United States	Cedars Sinai Medical Center ( Site 4010)	Los Angeles	California
United States	Pacific Arthritis Care Center ( Site 4008)	Los Angeles	California
United States	UCLA School of Medicine ( Site 4006)	Los Angeles	California
United States	Froedtert and Medical College of Wisconsin ( Site 4012)	Milwaukee	Wisconsin
United States	Rutgers Robert Wood Johnson Medical School ( Site 4013)	New Brunswick	New Jersey
United States	Yale University ( Site 4017)	New Haven	Connecticut
United States	Hospital For Special Surgery ( Site 4020)	New York	New York
United States	Stanford Health Care ( Site 4009)	Palo Alto	California
United States	Mayo Clinic - Scottsdale ( Site 4014)	Phoenix	Arizona
United States	University of Pittsburgh Medical Center ( Site 4016)	Pittsburgh	Pennsylvania
United States	University of Toledo Medical Center ( Site 4002)	Toledo	Ohio
United States	MedStar Georgetown University Hospital ( Site 4005)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Experience an Adverse Event (AE)	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.	Up to Week 50
Primary	Number of Participants who Experience a Serious Adverse Event (SAE)	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.	Up to Week 50
Primary	Number of Participants who Discontinue due to an AE	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.	Up to Week 50
Primary	Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at 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.	Baseline and up to Week 50
Secondary	Change from Baseline in FVC at 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.	Baseline and Week 50
Secondary	Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50	QILD-WL will be measured as percent lung involvement using HRCT.	Baseline and Week 50
Secondary	Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at 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.	Baseline and Week 50
Secondary	Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at 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.	Baseline and Week 50
Secondary	Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at 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.	Baseline and Week 50

External Links

•   Merck Clinical Trials Information