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Study of M5049 in DM and PM Participants (NEPTUNIA)

Primary Purpose

Dermatomyositis, Polymyositis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
M5049 high dose
Placebo
Sponsored by
EMD Serono Research & Development Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatomyositis focused on measuring Toll-like Receptor 7, Toll-like Receptor 8, Anti-synthetase syndrome, Idiopathic immune myopathies, Myositis, M5049

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of probable or definite DM or PM as per 2017 ACR/EULAR classification criteria, with positive autoantibody status. Anti-synthetase syndrome (ASyS) participants that meet classification criteria are allowed Active disease on standard of care (SoC), must meet 1 of the criteria within 6 months prior to Screening: Pathological evidence of active myositis in muscle biopsy; Evidence of active myositis by Electromyography (EMG); Magnetic resonance imaging (MRI) with evidence of active myositis; or any muscle enzyme greater than or equal to (>=) 4 × upper limit of normal (ULN) at time of Screening; Active PM/DM skin rash as per cutaneous dermatomyositis area and severity index-A (CDASI-A) >= 7 at time of Screening Minimum disease severity defined by: moderate to severe myopathy with manual muscle testing-8 (MMT-8) >= 80 and less than or equal to (<=) 142 AND at least 2 of the following core set measures (CSM) abnormalities: Patient Global Activity (PtGA) >= 2 centimeters (cm); Physician Global Activity (PGA) derived from myositis disease activity assessment tool (MDAAT) >= 2 cm; Extramuscular Activity Assessment derived from MDAAT >2 cm; At least 1 muscle enzyme > 1.5 times ULN; health assessment questionnaire-disability index (HAQ-DI) >= 0.25 Stable doses of oral corticosteroids (CS) and/or maximum of 1 non-corticosteroid immunosuppressive/immunomodulatory medications (methotrexate, 6 mercaptopurine, sulfasalazine, mycophenolate mofetil or sodium, azathioprine, leflunomide, cyclosporine, oral tacrolimus) for DM or PM Participants have a body mass index (BMI) lower or Equal to 40.0 kilograms per square meter (kg/m^2) Other protocol defined inclusion criteria could apply Exclusion Criteria: Primary diagnosis of inclusion body myositis (IBM), malignancy-associated myositis (defined as diagnosis of myositis within 3 years of cancer), immune mediated necrotizing myopathy (IMNM) with a biopsy characterized as necrotizing biopsy or IMNM with positive anti-signal recognition particle antibody (SRP) or anti 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) auto antibodies. Participants with anti-transcription intermediary factor 1 (TIF1) gamma antibody or newly diagnosed (within 1 year) anti MDAT5 antibody should have had adequate screening for cancer within 12 months of Day 1. Adequate screening of cancer is defined as up-to-date age and gender appropriate screening as per national guidelines Primary diagnosis of juvenile DM, or adult participants previously diagnosed with juvenile DM Any other active concurrent connective tissue disease associated with inflammatory myopathy in the Investigator's opinion. Eligibility of participants with diagnosis of concurrent connective tissue disease(s) will be reviewed and approved by an idiopathic inflammatory myopathies (IIM) expert committee Severe interstitial lung disease defined as supplemental oxygen required at rest, or forced vital capacity (FVC) of <60 percent (%) predicted. Participants within 1 year of PM/DM diagnosis and anti-MDA5 antibody, should have been evaluated for interstitial lung disease (ILD) with high resolution computed tomography (HRCT) Chest Any uncontrolled disease (for example [e.g.], severe respiratory, cardiovascular, gastrointestinal, neurological, psychiatric, hematological, metabolic [including thyroiditis with increased/decreased thyroid stimulating hormone (TSH)], renal [Estimated glomerular filtration rate < 40 milliliter per minute/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation by the central laboratory], hepatic, endocrine/reproductive organ disease) other than DM/PM, that in the Investigator's or Sponsor/designee's opinion constitutes an inappropriate risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation Other protocol defined exclusion criteria could apply

Sites / Locations

  • Neuromuscular Research CenterRecruiting
  • HonorHealth Research Institute - Bob Bove Neuroscience Institute-Neuroscience ResearchRecruiting
  • Mayo Clinic Scottsdale (6365)Recruiting
  • HMD Research LLCRecruiting
  • Augusta University-Rheumatology
  • Johns Hopkins University - Department of Medicine, Division of RheumatologyRecruiting
  • University of Minnesota-DermatologyRecruiting
  • University of Kansas Medical Center-NeuromuscularRecruiting
  • University of Pittsburgh
  • Austin Neuromuscular CenterRecruiting
  • Nerve and Muscle Center of Texas-Clinical researchRecruiting
  • Institute of Rheumatology - RheumatologyRecruiting
  • Hippokration Hospital - 2nd Department of Medicine and LaboratoryRecruiting
  • National and Kapodistrian University of Athens (Egnitio Hospital)
  • University General Hospital of Larissa
  • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaRecruiting
  • Azienda Usl Toscana CentroRecruiting
  • Arcispedale S. Maria NuovaRecruiting
  • Fondazione Policlinico Universitario A. Gemelli-IRCCS, UCSC - Scienze Mediche e ChirurgicheRecruiting
  • Instytut Reumatologii im. Eleonory Reicher - Department of Connective Tissue DiseasesRecruiting
  • CHUAC - Complexo Hospitalario Universitario A Coruña - Rheumatology
  • Hospital Vall d'HebronRecruiting
  • Hospital Universitario Ramon y Cajal, Madrid - Rheumatology DepartmentRecruiting
  • University College London Hospitals NHS Foundation Trust- Neuromuscular DiseasesRecruiting
  • Salford Royal Hospital, Barnes Clinical Research FacilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Double-blind Placebo Controlled (DBPC) Period: M5049 high dose

DBPC Period: Placebo

Open Label Extension (OLE) Period: M5049 high dose

Arm Description

Outcomes

Primary Outcome Measures

DBPC Period: American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24
DBPC Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
DBPC Period: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements

Secondary Outcome Measures

DBPC Period: Number of Participants with American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) Greater Than or Equal to (>=) 20, >= 40 and >= 60
DBPC Period: Total Improvement Score (TIS)
DBPC Period: Mean Score for Core Set Measures (CSM) from Week 4 up to Week 24.
DBPC Period: Percent Change from Baseline in Most Abnormal Muscle-associated Enzyme at Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Absolute Change from Baseline in the Core Set Measures (CSM) at Weeks 4, 8, 12, 16, 20 and 24'
DBPC Period: Percent Change from Baseline in Core Set Measures (CSM) at Weeks 4, 8, 12, 16, 20 and 24'
DBPC Period: Number of Participants with International Myositis Assessment and Clinical Studies (IMACS) Response
DBPC Period: Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) A and CDASI-D at Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Percent Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) A and CDASI-D at Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Change from Baseline in Investigator's Global Assessment (IGA) Skin Activity Score at Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Percent Change from Baseline in Investigator's Global Assessment (IGA) Skin Activity Score at Weeks 4, 8, 12, 16, 20 and 24
OLE Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
OLE Period: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements

Full Information

First Posted
December 6, 2022
Last Updated
October 20, 2023
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05650567
Brief Title
Study of M5049 in DM and PM Participants (NEPTUNIA)
Official Title
A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants Receiving Standard of Care (NEPTUNIA)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
July 16, 2024 (Anticipated)
Study Completion Date
December 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis, Polymyositis
Keywords
Toll-like Receptor 7, Toll-like Receptor 8, Anti-synthetase syndrome, Idiopathic immune myopathies, Myositis, M5049

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double-blind Placebo Controlled (DBPC) Period: M5049 high dose
Arm Type
Experimental
Arm Title
DBPC Period: Placebo
Arm Type
Placebo Comparator
Arm Title
Open Label Extension (OLE) Period: M5049 high dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
M5049 high dose
Other Intervention Name(s)
Enpatoran
Intervention Description
Participants will receive film-coated tablets of M5049 at a high dose orally, twice daily up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo matched to M5049 orally, twice daily up to 24 weeks.
Primary Outcome Measure Information:
Title
DBPC Period: American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24
Time Frame
at Week 24
Title
DBPC Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Time Frame
up to Week 26
Title
DBPC Period: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements
Time Frame
up to Week 26
Secondary Outcome Measure Information:
Title
DBPC Period: Number of Participants with American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) Greater Than or Equal to (>=) 20, >= 40 and >= 60
Time Frame
Week 16 and Week 24
Title
DBPC Period: Total Improvement Score (TIS)
Time Frame
Week 4 up to Week 20
Title
DBPC Period: Mean Score for Core Set Measures (CSM) from Week 4 up to Week 24.
Time Frame
Week 4 up to Week 24
Title
DBPC Period: Percent Change from Baseline in Most Abnormal Muscle-associated Enzyme at Weeks 4, 8, 12, 16, 20 and 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Title
DBPC Period: Absolute Change from Baseline in the Core Set Measures (CSM) at Weeks 4, 8, 12, 16, 20 and 24'
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Title
DBPC Period: Percent Change from Baseline in Core Set Measures (CSM) at Weeks 4, 8, 12, 16, 20 and 24'
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Title
DBPC Period: Number of Participants with International Myositis Assessment and Clinical Studies (IMACS) Response
Time Frame
Week 16 and Week 24
Title
DBPC Period: Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) A and CDASI-D at Weeks 4, 8, 12, 16, 20 and 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Title
DBPC Period: Percent Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) A and CDASI-D at Weeks 4, 8, 12, 16, 20 and 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Title
DBPC Period: Change from Baseline in Investigator's Global Assessment (IGA) Skin Activity Score at Weeks 4, 8, 12, 16, 20 and 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Title
DBPC Period: Percent Change from Baseline in Investigator's Global Assessment (IGA) Skin Activity Score at Weeks 4, 8, 12, 16, 20 and 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Title
OLE Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Time Frame
up to Week 50
Title
OLE Period: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements
Time Frame
up to Week 50

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of probable or definite DM or PM as per 2017 ACR/EULAR classification criteria, with positive autoantibody status. Anti-synthetase syndrome (ASyS) participants that meet classification criteria are allowed Active disease on standard of care (SoC), must meet 1 of the criteria within 6 months prior to Screening: Pathological evidence of active myositis in muscle biopsy; Evidence of active myositis by Electromyography (EMG); Magnetic resonance imaging (MRI) with evidence of active myositis; or any muscle enzyme greater than or equal to (>=) 4 × upper limit of normal (ULN) at time of Screening; Active PM/DM skin rash as per cutaneous dermatomyositis area and severity index-A (CDASI-A) >= 7 at time of Screening Minimum disease severity defined by: moderate to severe myopathy with manual muscle testing-8 (MMT-8) >= 80 and less than or equal to (<=) 142 AND at least 2 of the following core set measures (CSM) abnormalities: Patient Global Activity (PtGA) >= 2 centimeters (cm); Physician Global Activity (PGA) derived from myositis disease activity assessment tool (MDAAT) >= 2 cm; Extramuscular Activity Assessment derived from MDAAT >2 cm; At least 1 muscle enzyme > 1.5 times ULN; health assessment questionnaire-disability index (HAQ-DI) >= 0.25 Stable doses of oral corticosteroids (CS) and/or maximum of 1 non-corticosteroid immunosuppressive/immunomodulatory medications (methotrexate, 6 mercaptopurine, sulfasalazine, mycophenolate mofetil or sodium, azathioprine, leflunomide, cyclosporine, oral tacrolimus) for DM or PM Participants have a body mass index (BMI) lower or Equal to 40.0 kilograms per square meter (kg/m^2) Other protocol defined inclusion criteria could apply Exclusion Criteria: Primary diagnosis of inclusion body myositis (IBM), malignancy-associated myositis (defined as diagnosis of myositis within 3 years of cancer), immune mediated necrotizing myopathy (IMNM) with a biopsy characterized as necrotizing biopsy or IMNM with positive anti-signal recognition particle antibody (SRP) or anti 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) auto antibodies. Participants with anti-transcription intermediary factor 1 (TIF1) gamma antibody or newly diagnosed (within 1 year) anti MDAT5 antibody should have had adequate screening for cancer within 12 months of Day 1. Adequate screening of cancer is defined as up-to-date age and gender appropriate screening as per national guidelines Primary diagnosis of juvenile DM, or adult participants previously diagnosed with juvenile DM Any other active concurrent connective tissue disease associated with inflammatory myopathy in the Investigator's opinion. Eligibility of participants with diagnosis of concurrent connective tissue disease(s) will be reviewed and approved by an idiopathic inflammatory myopathies (IIM) expert committee Severe interstitial lung disease defined as supplemental oxygen required at rest, or forced vital capacity (FVC) of <60 percent (%) predicted. Participants within 1 year of PM/DM diagnosis and anti-MDA5 antibody, should have been evaluated for interstitial lung disease (ILD) with high resolution computed tomography (HRCT) Chest Any uncontrolled disease (for example [e.g.], severe respiratory, cardiovascular, gastrointestinal, neurological, psychiatric, hematological, metabolic [including thyroiditis with increased/decreased thyroid stimulating hormone (TSH)], renal [Estimated glomerular filtration rate < 40 milliliter per minute/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation by the central laboratory], hepatic, endocrine/reproductive organ disease) other than DM/PM, that in the Investigator's or Sponsor/designee's opinion constitutes an inappropriate risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation Other protocol defined exclusion criteria could apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Medical Information
Phone
888-275-7376
Email
eMediUSA@emdserono.com
First Name & Middle Initial & Last Name or Official Title & Degree
Communication Center
Phone
+49 6151 72 5200
Email
service@emdgroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Neuromuscular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
ksiva@nrcaz.com
First Name & Middle Initial & Last Name & Degree
Kumaraswamy Sivakumar
Facility Name
HonorHealth Research Institute - Bob Bove Neuroscience Institute-Neuroscience Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
hri.neuro.levine@gmail.com
First Name & Middle Initial & Last Name & Degree
Todd Levine
Facility Name
Mayo Clinic Scottsdale (6365)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
mangold.aaron@mayo.edu
First Name & Middle Initial & Last Name & Degree
Aaron Mangold
Facility Name
HMD Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
mheuer@heuermd.com
First Name & Middle Initial & Last Name & Degree
Marvin Heuer
Facility Name
Augusta University-Rheumatology
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
mfarrough@augusta.edu
First Name & Middle Initial & Last Name & Degree
Elena Schiopu
Facility Name
Johns Hopkins University - Department of Medicine, Division of Rheumatology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
lchrist4@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Lisa Christopher-Stine
Facility Name
University of Minnesota-Dermatology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
pearsond@umn.edu
First Name & Middle Initial & Last Name & Degree
David Pearson
Facility Name
University of Kansas Medical Center-Neuromuscular
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
mdimachkie@kumc.edu
First Name & Middle Initial & Last Name & Degree
Mazen Dimachkie
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
sim31@pitt.edu
First Name & Middle Initial & Last Name & Degree
Didem Saygin
Facility Name
Austin Neuromuscular Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
yessar@austinneuromuscle.com
First Name & Middle Initial & Last Name & Degree
Yessar Hussain
Facility Name
Nerve and Muscle Center of Texas-Clinical research
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
ataher@aol.com
First Name & Middle Initial & Last Name & Degree
Aziz Shaibani
Facility Name
Institute of Rheumatology - Rheumatology
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Email
vencovsky@revma.cz
First Name & Middle Initial & Last Name & Degree
Jiri Vencovsky
Facility Name
Hippokration Hospital - 2nd Department of Medicine and Laboratory
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
dvassilop@med.uoa.gr
First Name & Middle Initial & Last Name & Degree
Dimitrios Vassilopoulos
Facility Name
National and Kapodistrian University of Athens (Egnitio Hospital)
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
Email
gkpapad@yahoo.gr
First Name & Middle Initial & Last Name & Degree
George Papadimas
Facility Name
University General Hospital of Larissa
City
Larissa
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
City
Catania
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Usl Toscana Centro
City
Florence
Country
Italy
Individual Site Status
Recruiting
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario A. Gemelli-IRCCS, UCSC - Scienze Mediche e Chirurgiche
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Name
Instytut Reumatologii im. Eleonory Reicher - Department of Connective Tissue Diseases
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
marzena.olesinska@vp.pl
First Name & Middle Initial & Last Name & Degree
Marzena Olesinska
Facility Name
CHUAC - Complexo Hospitalario Universitario A Coruña - Rheumatology
City
A Coruna
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34 686 093 378
Email
aselva@vhebron.net
First Name & Middle Initial & Last Name & Degree
Albert Selva-O'Callaghan
Facility Name
Hospital Universitario Ramon y Cajal, Madrid - Rheumatology Department
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34 913 368 111
Email
fbachiller@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Javier Bachiller Corral
Facility Name
University College London Hospitals NHS Foundation Trust- Neuromuscular Diseases
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Salford Royal Hospital, Barnes Clinical Research Facility
City
Salford
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD Sharing Time Frame
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD Sharing Access Criteria
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
IPD Sharing URL
https://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200569_0041
Description
Trial Awareness and Transparency website
URL
https://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources

Learn more about this trial

Study of M5049 in DM and PM Participants (NEPTUNIA)

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