A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

NCT05523167 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ARGX-113-20072024-512785-33-00
• Study Type: interventional
• Target: 265
• Locations: 34 countries
• Sites: 199

Brief Summary

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome \[ASyS\]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

Conditions

Active Idiopathic Inflammatory Myopathy; Myositis; Dermatomyositis; Polymyositis; Immune-Mediated Necrotizing Myopathy; Antisynthetase Syndrome

Outcome Measures

Primary Outcomes (1)

• Total improvement score (TIS); measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).

  phase 2: 24 weeks; phase 3: 52 weeks

Secondary Outcomes (8)

• Time to reach TIS ≥ 20 (first "minimal clinical improvement")

  phase 2: up to 24 weeks; phase 3: up to 52 weeks

• Percentage of participants with TIS ≥ 20

  phase 2: 24 weeks; phase 3: 52 weeks

• Time to reach TIS ≥ 40 (first "moderate clinical improvement")

  phase 2: up to 24 weeks; phase 3: up to 52 weeks

• Percentage of participants with TIS ≥ 40

  phase 2: 24 weeks; phase 3: 52 weeks

• Change in manual muscle testing-8 (MMT8) score

  phase 2: 24 weeks; phase 3: 52 weeks

Study Arms (2)

EFG PH20 SC

EXPERIMENTAL

participants receiving efgartigimod PH20 SC on top of background treatment

Biological: EFG PH20 SC

PBO PH20 SC

PLACEBO COMPARATOR

participants receiving placebo PH20 SC on top of background treatment

Other: PBO

Interventions

EFG PH20 SC BIOLOGICAL

Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer

EFG PH20 SC

PBO OTHER

Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer

PBO PH20 SC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent.
• A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM)
• One of the following medical histories: Diagnosis of dermatomyositis (DM) or juvenile dermatomyositis (JDM), Diagnosis of polymyositis (PM) (including antisynthetase syndrome (ASyS)), Diagnosis of immune-mediated necrotizing myopathy (IMNM)
• Diagnosed with active disease as defined by the presence of at least 1 of the following criteria: Abnormal levels of at least 1 of the following enzymes: creatine kinase (CK), aldolase, lactate dehydrogenase, aspartate aminotransaminase (AST), alanine aminotransferase (ALT), based on central laboratory results; Electromyography demonstrating active disease within the past 3 months; Active dermatomyositis (DM) skin rash; Muscle biopsy indicative of active idiopathic inflammatory myopathy (IIM) in the past 3 months; Magnetic resonance imaging within the past 3 months indicative of active inflammation
• Muscle weakness
• Receiving a permitted background treatment for idiopathic inflammatory myopathy.
• Contraceptive use consistent with local regulations, where available, for individuals participating in clinical studies. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).

You may not qualify if:

• A clinically significant active infection at screening
• A COVID-19 polymerase chain reaction (PCR)-positive test before enrollment
• Any other known autoimmune disease that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of idiopathic inflammatory myopathy (IIM) or put the patient at undue risk
• A history of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for ≥ 3 years before the first administration of the investigational medicinal product (IMP). Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer ; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
• Severe muscle damage
• Glucocorticoid-induced myopathy that the investigator considers the primary cause of muscle weakness or permanent weakness linked to a non-idiopathic inflammatory myopathy (IIM) cause
• Juvenile myositis (JDM) diagnosed \> 5 years from screening or juvenile myositis with extensive calcinosis or severe calcinosis.
• Uncontrolled interstitial lung disease or any other uncontrolled idiopathic inflammatory myopathy (IIM) manifestation that, in the opinion of the investigator, would be likely to require treatment with prohibited medication during the study
• Clinically significant disease, recent major surgery or intends to have surgery during the study, or has any other condition in the opinion of the investigator that could confound the results of the trial or put the patient at undue risk
• Known hypersensitivity reaction to investigational medicinal product (IMP) or 1 of its excipients
• Received a live or live-attenuated vaccine less than 4 weeks before screening.
• Positive serum test at screening for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV
• Participant has previously participated in an efgartigimod clinical trial and received at least 1 dose of investigational medicinal product (IMP).
• Participant is concurrently participating in any other clinical study, including a noninterventional study.
• Participant has a current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse.

Sponsors & Collaborators

• argenx: lead

Study Sites (202)

Neuromuscular Research Center

Phoenix, Arizona, 85028, United States

Location

HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology

Scottsdale, Arizona, 85251, United States

Location

Attune Health Research, Inc

Beverly Hills, California, 90039, United States

Location

University of Southern California Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Profound Research LLC - Oceanside

Oceanside, California, 92056, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine

Redwood City, California, 94063-3132, United States

Location

California Pacific Medical Center - Sutter Health

San Francisco, California, 94109, United States

Location

Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)

San Francisco, California, 94143-2202, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230, United States

Location

Yale Cancer Center-Yale University School Of Medicine

New Haven, Connecticut, 06520, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

UF Health Rheumatology

Gainesville, Florida, 32610-3008, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)

Tampa, Florida, 33616, United States

Location

Emory University Hospital, The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30312, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins Medicine - Johns Hopkins Myositis Center

Baltimore, Maryland, 21224, United States

Location

Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)

Boston, Massachusetts, 02115-6110, United States

Location

Michigan State University - Neurology

East Lansing, Michigan, 48824, United States

Location

St. Paul Rheumatology, PA

Saint Paul, Minnesota, 55121, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

University of North Carolina (UNC) School of Medicine

Chapel Hill, North Carolina, 27514-4220, United States

Location

Carolina Arthritis Associates

Wilmington, North Carolina, 28401, United States

Location

Cleveland Clinic - Main Campus

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43201, United States

Location

Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology

Oklahoma City, Oklahoma, 73120, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic

Nashville, Tennessee, 37232-0028, United States

Location

Austin Neuromuscular Center

Austin, Texas, 78759, United States

Location

McGovern Medical School -The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Nerve And Muscle Center Of Texas

Houston, Texas, 77030, United States

Location

University of Vermont Medical Center - Main Campus

Burlington, Vermont, 05401, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Consultora Integral de Salud

Córdoba, 5000, Argentina

Location

Framingham Centro Medico

La Plata, B1902COS, Argentina

Location

Dim Clinica Privada

Ramos Mejía, B1704ETD, Argentina

Location

Centro Dermatologico Schejtman

San Miguel, B1663GKT, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL, Argentina

Location

The Wesley Medical Research

Auchenflower, 4066, Australia

Location

Fiona Stanley Hospital

Murdoch, 6150, Australia

Location

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

Vienna, 1090, Austria

Location

Centre Hospitalier Universitaire de Charleroi

Charleroi, 6042, Belgium

Location

AZ Sint Lucas Gent-Campus Sint Lucas

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman

Liège, 4000, Belgium

Location

Medical Centre Artmed

Plovdiv, 4002, Bulgaria

Location

Multiprofile hospital for active treatment Kaspela EOOD

Plovdiv, 4002, Bulgaria

Location

Genge Partners

Montreal, H4A 3T2, Canada

Location

Ottawa Hospital Research Institute-Civic Campus

Ottawa, K1Y 4E9, Canada

Location

Peking University First Hospital

Beijing, 100034, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

Xiangya Hospital Central South University

Changsha, 410008, China

Location

The Second Xiangya Hospital of Central South University

Changsha, 410011, China

Location

Sichuan Provincial Peoples Hospital

Chengdu, 610072, China

Location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, 510000, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, 510515, China

Location

The First Affiliated Hospital - School of Medicine - ZheJiang University

Hangzhou, 310003, China

Location

Anhui Provincial Hospital

Hefei, 230001, China

Location

The Second Affiliated Hospital Of Nanchang University

Nanchang, 330000, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, 200000, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

Shanghai Renji Hospital

Shanghai, 200127, China

Location

First Affiliated Hospital of Shanxi Medical College

Shanxi, 30001, China

Location

China Medical University (CMU) - First Affiliated Hospital

Shenyang, 110001, China

Location

Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital

Wuhan, 430030, China

Location

First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University

Zhengzhou, 450052, China

Location

Cyprus Institute of Neurology and Genetics

Nicosia, 2371, Cyprus

Location

Revmatologicky ustav

Prague, 128 00, Czechia

Location

Copenhagen University Hospital-Rigshospitalet University Hospital

Copenhagen, 2100, Denmark

Location

Hopital Edouard Herriot

Lyon, 69003, France

Location

Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix

Paris, 75013, France

Location

Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen

Rouen, 76031, France

Location

Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes

Strasbourg, 67098, France

Location

American Hospital Network

Tbilisi, 0102, Georgia

Location

LTD New Hospitals

Tbilisi, 0114, Georgia

Location

Aversi Clinic

Tbilisi, 0160, Georgia

Location

LLC MediClub Georgia

Tbilisi, 0179, Georgia

Location

The First Medical Center

Tbilisi, 0180, Georgia

Location

LTD Tbilisi Heart Center

Tbilisi, 0186, Georgia

Location

Charite - Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Universitatsmedizin Gottingen - Georg-August-Universitat

Göttingen, 37075, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

Universitatsmedizin Mannheim

Mannheim, 68167, Germany

Location

Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik

München, 80336, Germany

Location

St. Josef-Stift Sendenhorst

Sendenhorst, 48324, Germany

Location

Universitaetsklinikum Tuebingen (UKT)

Tübingen, 72076, Germany

Location

Universitatsklinikum Ulm - Standort Oberer Eselsberg

Ulm, 89081, Germany

Location

National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine

Athens, 115 27, Greece

Location

National and Kapodistrian University of Athens - Eginition Hospital

Athens, 115 28, Greece

Location

Attikon General University Hospital

Athens, 12462, Greece

Location

Athens Medical Center

Athens, 151 25, Greece

Location

University of Ioannina Medical School

Ioannina, 45110, Greece

Location

Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders

Budapest, 1083, Hungary

Location

Debreceni Egyetem - University of Debrecen

Debrecen, 4032, Hungary

Location

St. Vincents University Hospital

Dublin, D04 T6F4, Ireland

Location

Connolly Hospital Blanchardstown

Dublin, D15 X40D, Ireland

Location

North West Rheumatology Unit - Our Lady's Hospital

Manorhamilton, F91 X012, Ireland

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)

Petah Tikva, 49100, Israel

Location

Sheba Medical Center - Rheumatology

Ramat Gan, 52621, Israel

Location

Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology

Bari, 70124, Italy

Location

Azienda Ospedaliero Universitaria Careggi

Florence, 50139, Italy

Location

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital

Milan, 20132, Italy

Location

San Matteo Hospital

Pavia, 27100, Italy

Location

A.O. Universitaria Pisana

Pisa, 56126, Italy

Location

IRCCS Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

Azienda Ospedaliero Universitaria Sant'Andrea

Roma, 00189, Italy

Location

IRCCS Istituto Clinico Humanitas - Rheumatology

Rozzano, 20089, Italy

Location

Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette

Torino, 10126, Italy

Location

ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia

Udine, 33100, Italy

Location

Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma

Verona, 37134, Italy

Location

Tokyo Medical And Dental University Hospital, Faculty of Medicine

Bunkyō City, 113-8519, Japan

Location

Nippon Medical School - Nippon Medical School Hospital

Bunkyō City, 113-8603, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, 216-8511, Japan

Location

Kurume University Hospital

Kurume, 830-0011, Japan

Location

Chiba-Nishi General Hospital

Matsudo-shi, 270-2251, Japan

Location

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, 457-8510, Japan

Location

Kitasato University Hospital (KUH)

Sagamihara-shi, 252-0375, Japan

Location

Sapporo City Hospital

Sapporo, 060-8604, Japan

Location

Hokkaido University Hospital - Rheumatology

Sapporo, 060-8648, Japan

Location

Sasebo Chuo Hospital

Sasebo-shi, 857-1165, Japan

Location

Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Juntendo University Hospital - Rheumatology

Tokyo, 113-8431, Japan

Location

The University of Tokyo Hospital

Tokyo, 113-8655, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

University of Tsukuba Hospital - Rheumatology

Tsukuba, 305-8576, Japan

Location

Yamaguchi University Hospital

Ube-shi, 755-8505, Japan

Location

Wakayama Medical University Hospital - Dermatology

Wakayama, 641-8509, Japan

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50161, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.

Mexico City, 06700, Mexico

Location

Centro Peninsular De Investigacion Clinica

Mérida, 97000, Mexico

Location

Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)

Amsterdam, 1105 AZ, Netherlands

Location

Universitair Medisch Centrum Utrecht (UMC Utrecht)

Utrecht, 3584 CX, Netherlands

Location

Hogar Clinica San Juan de Dios

Arequipa, 4018, Peru

Location

Investigaciones Clinicas S.A.C.

Lima, 15023, Peru

Location

Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar

Lima, 27, Peru

Location

Hospital Nacional Cayetano Heredia

Lima, 31, Peru

Location

Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113

Lodz, 90-549, Poland

Location

Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie

Szczecin, 71-252, Poland

Location

Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar Universitario de Santo Antonio

Porto, 4099-001, Portugal

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Narodny ustav reumatickych chorob

Piešťany, 92112, Slovakia

Location

Chungnam National University Hospital (CNUH)

Daejeon, 35015, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Kyung Hee University Medical Center

Seoul, 02447, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 451086, Spain

Location

Hospital De Valme

Seville, 9-41014, Spain

Location

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

Location

Hospital Do Meixoeiro

Vigo, 36200, Spain

Location

Karolinska Universitestssjukhus Solna

Stockholm, 17164, Sweden

Location

Neurocenter of Southern Switzerland

Lugano, 6900, Switzerland

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

China Medical University and Hospital

Taichung, 40402, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)

Bangkok, 10300, Thailand

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Ramathibodi hospital

Bangkok, 10400, Thailand

Location

Siriraj Hospital, Mahidol University of Internal medicine

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Khon Kaen University

Khon Kaen, 40000, Thailand

Location

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

Ankara University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Medical Faculty

Konya, 42090, Turkey (Türkiye)

Location

Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust

Bath, BA1 3NG, United Kingdom

Location

Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust

Doncaster, DN2 5LT, United Kingdom

Location

Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds

Leeds, LS7 4SA, United Kingdom

Location

Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust

Liverpool, L9 7AL, United Kingdom

Location

The Royal Free Hospital - Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

James Cook University Hospital - South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

Related Links

• Study website

MeSH Terms

Conditions

Myositis; Dermatomyositis; Polymyositis; Antisynthetase syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: August 31, 2022
• Study Start: October 12, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2); IE (3); TU (3); SE (2); AU (2); GE (6); CY (1); TW (3); GR (5); CH (1); CZ (1); BE (4); NL (2); DK (1); FR (4); IL (5); HU (2); BU (2); SL (1); US (40); IT (12); DE (10); JP (18); PE (4); PT (2); ES (9); KR (6); AR (5); CN (20); CA (2); PL (3); TH (7); GB (9); LI (2)