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) (ATHENA-SSc-ILD)

April 4, 2024 updated by: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital ( Site 4050)
        • Contact:
          • Study Coordinator
          • Phone Number: 61870740000
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • Recruiting
        • St Vincents Hospital Melbourne ( Site 4051)
        • Contact:
          • Study Coordinator
          • Phone Number: 61394174844
  • Belgium
      • Liege, Belgium, 4000
        • Recruiting
        • CHU de Liege ( Site 4400)
        • Contact:
          • Study Coordinator
          • Phone Number: 3243667863
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 4401)
        • Contact:
          • Study Coordinator
          • Phone Number: 329-332-2856
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 4402)
        • Contact:
          • Study Coordinator
          • Phone Number: 321-634-6802
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1W9
        • Recruiting
        • University Of Alberta Hospital ( Site 4702)
        • Contact:
          • Study Coordinator
          • Phone Number: 780-492-7481
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Recruiting
        • St. Joseph's Health Care London ( Site 4701)
        • Contact:
          • Study Coordinator
          • Phone Number: 519-646-6332
      • Toronto, Ontario, Canada, M5T 3L9
        • Recruiting
        • Mount Sinai Hospital [Toronto, Canada] ( Site 4700)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-586-4800
  • France
      • Paris, France, 75679
        • Recruiting
        • Hopital Cochin ( Site 4203)
        • Contact:
          • Study Coordinator
          • Phone Number: 33158412563
    • Nord
      • Bordeaux, Nord, France, 33076
        • Recruiting
        • CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
        • Contact:
          • Study Coordinator
          • Phone Number: 33556795556
      • Lille, Nord, France, 59000
        • Recruiting
        • Hôpital Claude Huriez ( Site 4200)
        • Contact:
          • Study Coordinator
          • Phone Number: 33320445928
  • Germany
    • Baden-Wurttemberg
      • Freiburg, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg ( Site 4152)
        • Contact:
          • Study Coordinator
          • Phone Number: 4976127034480
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • Recruiting
        • Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)
        • Contact:
          • Study Coordinator
          • Phone Number: 4960329962101
    • Mecklenburg-Vorpommern
      • Hohenfelde B Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
        • Recruiting
        • Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)
        • Contact:
          • Study Coordinator
          • Phone Number: 4938203731920
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln ( Site 4151)
        • Contact:
          • Study Coordinator
          • Phone Number: 49401818811125
  • Hungary
      • Budapest, Hungary, 1023
        • Recruiting
        • Budai Irgalmasrendi Korhaz ( Site 4252)
        • Contact:
          • Study Coordinator
          • Phone Number: 36302892319
      • Budapest, Hungary, 1097
        • Recruiting
        • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)
        • Contact:
          • Study Coordinator
          • Phone Number: 36209266272
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont ( Site 4251)
        • Contact:
          • Study Coordinator
          • Phone Number: 3652411600
    • Baranya
      • Pecs, Baranya, Hungary, 7632
        • Recruiting
        • Pecsi Tudomanyegyetem AOK ( Site 4250)
        • Contact:
          • Study Coordinator
          • Phone Number: 3672563001
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Medical Center ( Site 4601)
        • Contact:
          • Study Coordinator
          • Phone Number: 97247772268
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center ( Site 4604)
        • Contact:
          • Study Coordinator
          • Phone Number: 97297472592
      • Nahariya, Israel, 2210001
        • Recruiting
        • Galilee Medical Center ( Site 4602)
        • Contact:
          • Study Coordinator
          • Phone Number: 97247771180
      • Petach Tikvah, Israel, 49100
        • Recruiting
        • Rabin Medical Center ( Site 4603)
        • Contact:
          • Study Coordinator
          • Phone Number: 97239376947
      • Ramat-Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 4605)
        • Contact:
          • Study Coordinator
          • Phone Number: 972544721675
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center ( Site 4606)
        • Contact:
          • Study Coordinator
          • Phone Number: 97236973668
  • Italy
      • Firenze, Italy, 50141
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi ( Site 4301)
        • Contact:
          • Study Coordinator
          • Phone Number: 390557949271
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino ( Site 4305)
        • Contact:
          • Study Coordinator
          • Phone Number: 390103537994
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Arcispedale Santa Maria Nuova ( Site 4300)
        • Contact:
          • Study Coordinator
          • Phone Number: 390522296780
      • Roma, Italy, 00161
        • Recruiting
        • Azienda Policlinico Umberto I ( Site 4302)
        • Contact:
          • Study Coordinator
          • Phone Number: 390649974641
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo ( Site 4303)
        • Contact:
          • Study Coordinator
          • Phone Number: +390382503777
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • Recruiting
        • A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)
        • Contact:
          • Study Coordinator
          • Phone Number: +390116335548
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Recruiting
        • Radboud University Medical Center ( Site 4650)
        • Contact:
          • Study Coordinator
          • Phone Number: 31243617687
  • Norway
      • Oslo, Norway, 0372
        • Recruiting
        • Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
        • Contact:
          • Study Coordinator
          • Phone Number: 4722029430
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 52-416
        • Recruiting
        • Centrum Medyczne Oporow ( Site 4455)
        • Contact:
          • Study Coordinator
          • Phone Number: 48607937936
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
        • Recruiting
        • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)
        • Contact:
          • Study Coordinator
          • Phone Number: 48535557777
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-691
        • Recruiting
        • Centrum Medyczne Reuma Park NZOZ ( Site 4450)
        • Contact:
          • Study Coordinator
          • Phone Number: 48602122803
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-276
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)
        • Contact:
          • Study Coordinator
          • Phone Number: 48858318482
    • Slaskie
      • Bytom, Slaskie, Poland, 41-902
        • Recruiting
        • Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)
        • Contact:
          • Study Coordinator
          • Phone Number: 48604752460
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 61-293
        • Recruiting
        • Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
        • Contact:
          • Study Coordinator
          • Phone Number: 48600334380
      • Warszawa, Wielkopolskie, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site
        • Contact:
          • Study Coordinator
          • Phone Number: 48228445845
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)
        • Contact:
          • Study Coordinator
          • Phone Number: 34932746090
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital Santa Creu i Sant Pau ( Site 4102)
        • Contact:
          • Study Coordinator
          • Phone Number: 34934552331
      • Madrid, Spain, 28026
        • Recruiting
        • Hospital Universitario 12 de Octubre ( Site 4106)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913908312
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal ( Site 4101)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913368710
      • Malaga, Spain, 29009
        • Recruiting
        • Hospital Regional Universitario de Malaga ( Site 4104)
        • Contact:
          • Study Coordinator
          • Phone Number: 34951290360
      • Valencia, Spain, 46017
        • Recruiting
        • Hospital Universitario Doctor Peset ( Site 4103)
        • Contact:
          • Study Coordinator
          • Phone Number: 34961622372
      • Zaragoza, Spain, 50009
        • Completed
        • Hospital Clinico Universitario Lozano Blesa ( Site 4100)
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
        • Contact:
          • Study Coordinator
          • Phone Number: 34932275774
  • Switzerland
      • Geneve, Switzerland, 1211
        • Recruiting
        • Hopitaux Universitaires de Geneve HUG ( Site 4503)
        • Contact:
          • Study Coordinator
          • Phone Number: +41223723694
      • Zurich, Switzerland, 8091
        • Recruiting
        • Universitaetsspital Zuerich ( Site 4500)
        • Contact:
          • Study Coordinator
          • Phone Number: 41442552970
    • Berne
      • Bern, Berne, Switzerland, 3010
        • Recruiting
        • Inselspital Bern ( Site 4502)
        • Contact:
          • Study Coordinator
          • Phone Number: 41316641739
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Kantonsspital St. Gallen ( Site 4501)
        • Contact:
          • Study Coordinator
          • Phone Number: 41714941439
  • United Kingdom
      • Leeds, United Kingdom, LS7 4SA
        • Recruiting
        • Chapel Allerton Hospital ( Site 4551)
        • Contact:
          • Study Coordinator
          • Phone Number: 441133924749
    • London, City Of
      • London, London, City Of, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital ( Site 4550)
        • Contact:
          • Study Coordinator
          • Phone Number: 442073177544
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic - Scottsdale ( Site 4014)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-301-8368
    • California
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Pacific Arthritis Care Center ( Site 4008)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-297-6812
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center ( Site 4010)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-502-3475
      • Los Angeles, California, United States, 90095-1670
        • Recruiting
        • UCLA School of Medicine ( Site 4006)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-825-2448
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Health Care ( Site 4009)
        • Contact:
          • Study Coordinator
          • Phone Number: 650-723-6961
    • Colorado
      • Denver, Colorado, United States, 80206
        • Recruiting
        • National Jewish Health Medical Center ( Site 4015)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-270-2631
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University ( Site 4017)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-925-3637
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital ( Site 4005)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-444-6200
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-550-7715
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital ( Site 4003)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-726-7938
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University School of Medicine ( Site 4021)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-358-6784
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital ( Site 4001)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-232-2090
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School ( Site 4013)
        • Contact:
          • Study Coordinator
          • Phone Number: 732-418-8484
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital For Special Surgery ( Site 4020)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-774-2123
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation ( Site 4019)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-444-9945
      • Toledo, Ohio, United States, 43614
        • Recruiting
        • University of Toledo Medical Center ( Site 4002)
        • Contact:
          • Study Coordinator
          • Phone Number: 419-383-4271
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center ( Site 4016)
        • Contact:
          • Study Coordinator
          • Phone Number: 412-647-6700
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina - PPDS ( Site 4004)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-792-7093
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Physicians Rheumatology ( Site 4007)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-500-6900
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert and Medical College of Wisconsin ( Site 4012)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-805-7390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered by IV infusion
Drug: Placebo
Placebo
Diagnostic test: Companion diagnostic ( CDx)
CDx+ or CDx-
Experimental: Tulisokibart
Tulisokibart IV administered by IV infusion
Drug: Tulisokibart
Tulisokibart administered at timepoints as directed by the protocol
Other Names:
  • PRA023
  • MK-7240
Diagnostic test: Companion diagnostic ( CDx)
CDx+ or CDx-

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who Experience an Adverse Event (AE)
Time Frame: 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.
Up to Week 50
Number of Participants who Experience a Serious Adverse Event (SAE)
Time Frame: 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.
Up to Week 50
Number of Participants who Discontinue due to an AE
Time Frame: 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.
Up to Week 50
Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50
Time Frame: 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.
Baseline and up to Week 50

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in FVC at Week 50
Time Frame: 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.
Baseline and Week 50
Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50
Time Frame: Baseline and Week 50
QILD-WL will be measured as percent lung involvement using HRCT.
Baseline and Week 50
Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at Week 50
Time Frame: 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.
Baseline and Week 50
Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50
Time Frame: 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.
Baseline and Week 50
Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at Week 50
Time Frame: 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.
Baseline and Week 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Prometheus Biosciences, Clinical Trials Call Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2022

Primary Completion (Estimated)

December 19, 2025

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

February 27, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240-007
  • PR200-104 (Other Identifier: PrometheusBio)
  • 2021-005206-10 (EudraCT Number)
  • MK-7240-007 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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