Interstitial Lung Disease Clinical Trial
— ATHENA-SSc-ILDOfficial 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)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
United States, Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom,
| 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 |
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