A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
Launched by ARGENX · Aug 30, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment called efgartigimod PH20 SC for adults with a condition known as Idiopathic Inflammatory Myopathy (IIM), which includes subtypes like dermatomyositis and polymyositis. The main goal is to see how well this treatment works compared to a placebo (a harmless substance with no active medicine) in helping participants feel better. To be eligible for the study, participants need to have a confirmed diagnosis of IIM, show signs of active disease, and have muscle weakness. They also need to be able to give informed consent and meet certain health criteria.
If you join the trial, you will receive either the active treatment or a placebo, and your progress will be monitored closely. The researchers will assess your improvement using a scoring system that looks at various factors related to your condition. This study is currently recruiting participants of all genders aged 65 to 74. It's important to note that participants should not have certain other health issues, infections, or recent surgeries that could impact the study. For more information about the trial and what participation involves, you can visit the study's website at https://myositis-study.com/.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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).
- • The full list of inclusion criteria can be found in the protocol.
- Exclusion Criteria:
- • 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
- • Other inflammatory and noninflammatory myopathies: inclusion body myositis, overlap myositis), metabolic myopathies, muscle dystrophies or a family history of muscle dystrophy, drug-induced or endocrine induced myositis, and juvenile myositis (other than juvenile dermatomyositis (JDM))
- • 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.
- • Participant is pregnant or lactating or intends to become pregnant during the study.
- • Participant has severe renal impairment .
- • Participant is institutionalized by a court or other governmental order or is in a dependent relationship with the sponsor or investigator.
- • The full list of exclusion criteria can be found in the protocol.
About Argenx
Argenx is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of autoimmune diseases and cancer. Leveraging its proprietary antibody engineering platform, the company focuses on harnessing the power of its unique antibody candidates to address unmet medical needs. With a commitment to advancing patient care, argenx collaborates with healthcare professionals and stakeholders to drive clinical research and deliver cutting-edge solutions that enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Kansas City, Kansas, United States
Minneapolis, Minnesota, United States
Orange, California, United States
New York, New York, United States
Saint Louis, Missouri, United States
Chicago, Illinois, United States
Rancho Mirage, California, United States
Chicago, Illinois, United States
Jacksonville, Florida, United States
Madrid, , Spain
Miami, Florida, United States
Cleveland, Ohio, United States
Seattle, Washington, United States
Portland, Oregon, United States
Dallas, Texas, United States
Duncansville, Pennsylvania, United States
Haifa, , Israel
Bangkok, , Thailand
Washington, District Of Columbia, United States
Denver, Colorado, United States
Taipei, , Taiwan
Guangzhou, , China
San Antonio, Texas, United States
Innsbruck, , Austria
Belgrade, , Serbia
Taichung City, , Taiwan
Alicante, , Spain
Sapporo, , Japan
Kurume, , Japan
Gent, , Belgium
Beijing, , China
Beijing, , China
Madrid, , Spain
Beijing, , China
Wien, , Austria
Hamburg, , Germany
Duesseldorf, , Germany
Seoul, , Korea, Republic Of
Valencia, , Spain
Beijing, , China
Chiang Mai, , Thailand
Pavia, , Italy
Kfar Saba, , Israel
Tokyo, , Japan
Tokushima, , Japan
Houston, Texas, United States
Changsha, , China
Sofia, , Bulgaria
Herne, , Germany
Tokyo, , Japan
Bangkok, , Thailand
Muenster, , Germany
Leipzig, , Germany
Wilmington, North Carolina, United States
Lima, , Peru
Beijing, , China
Lyon, , France
Belgrade, , Serbia
Wels, , Austria
Beijing, , China
London, , United Kingdom
Liège, , Belgium
Incheon, , Korea, Republic Of
Columbus, Ohio, United States
Nijmegen, , Netherlands
Beijing, , China
Vilnius, , Lithuania
Vigo, , Spain
Düsseldorf, , Germany
Los Angeles, California, United States
Jinan, , China
A Coruna, , Spain
Changsha, Hunan, China
Chongqing, , China
Changchun, , China
Guangzhou, , China
London, , United Kingdom
Sevilla, , Spain
Nanjing, , China
Bydgoszcz, , Poland
Beijing, , China
Tokyo, , Japan
Louisville, Kentucky, United States
Halle, , Germany
Suita, , Japan
Shanghai, , China
Bad Abbach, , Germany
Aurora, Colorado, United States
Houston, Texas, United States
Ramos Mejía, , Argentina
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Haifa, , Israel
Sendenhorst, , Germany
Barcelona, Catalonia, Spain
Hangzhou, , China
Phoenix, Arizona, United States
Murdoch, , Australia
Daejeon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Sendai Shi, , Japan
Ube Shi, , Japan
Changsha, , China
Tainan, , Taiwan
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Pisa, , Italy
Trento, , Italy
Hefei, , China
Bern, , Switzerland
Rosario, , Argentina
San Luis Potosi, , Mexico
Mannheim, , Germany
Great Neck, New York, United States
Shanghai, , China
Guangzhou, , China
Khon Kaen, , Thailand
Reggio Emilia, , Italy
Taichung, , Taiwan
Taiyuan, , China
Konya, , Turkey
Changchun, , China
Tianjin, , China
Ankara, , Turkey
Atlanta, Georgia, United States
Mexico City, , Mexico
Changsha, , China
Beijing, , China
Chengdu, Sichuan, China
Dublin, , Ireland
Nagoya, , Japan
Yamaguchi, , Japan
Firenze, , Italy
Redwood City, California, United States
Athens, , Greece
Hefei, , China
Kumamoto City, , Japan
Kawasaki, , Japan
Palo Alto, California, United States
Riga, , Latvia
La Plata, , Argentina
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Brasov, , Romania
Cleveland, Ohio, United States
Lisboa, , Portugal
Kaunas, , Lithuania
Montreal, , Canada
Shenyang, , China
Padova, , Italy
Pathum Thani, , Thailand
Shanghai, , China
Berlin, , Germany
Ankara, , Turkey
Tbilisi, , Georgia
Praha, , Czechia
Tbilisi, , Georgia
Strasbourg, , France
San Francisco, California, United States
Shanghai, , China
El Paso, Texas, United States
Plovdiv, , Bulgaria
Dublin, , Ireland
Shanghai, , China
Dallas, Texas, United States
London, , United Kingdom
Chongqing, , China
Madrid, , Spain
Austin, Texas, United States
New Orleans, Louisiana, United States
Amsterdam, , Netherlands
Matsudo Shi, , Japan
Beverly Hills, California, United States
St.Gallen, , Switzerland
Beverly Hills, California, United States
Wilmington, North Carolina, United States
Austin, Texas, United States
Houston, Texas, United States
Scottsdale, Arizona, United States
Pamplona, , Spain
Plovdiv, , Bulgaria
Phoenix, Arizona, United States
Orange, California, United States
Denver, Colorado, United States
Pittsburgh, Pennsylvania, United States
Plovdiv, , Bulgaria
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Seoul, , Korea, Republic Of
Taichung City, , Taiwan
Phoenix, Arizona, United States
Beverly Hills, California, United States
Orange, California, United States
Denver, Colorado, United States
Wilmington, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Austin, Texas, United States
Houston, Texas, United States
Plovdiv, , Bulgaria
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Budapest, , Hungary
Debrecen, , Hungary
Seoul, , Korea, Republic Of
Tampa, Florida, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Houston, Texas, United States
San Miguel De Tucumán, , Argentina
Auchenflower, , Australia
Murdoch, , Australia
Innsbruck, , Austria
Liège, , Belgium
Plovdiv, , Bulgaria
Nicosia, , Cyprus
Paris, , France
Strasbourg, , France
Tuebingen, , Germany
Athens, , Greece
Athens, , Greece
Athens, , Greece
Firenze, , Italy
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Amsterdam, , Netherlands
Szczecin, , Poland
Alicante, , Spain
Sevilla, , Spain
Valencia, , Spain
Vigo, , Spain
Stockholm, , Sweden
Lugano, , Switzerland
Bangkok, , Thailand
Kansas City, Kansas, United States
Leuven, , Belgium
Copenhagen, , Denmark
Pavia, , Italy
Roma, , Italy
Daejeon, , Korea, Republic Of
Incheon, , Korea, Republic Of
Kaunas, , Lithuania
Vilnius, , Lithuania
Utrecht, , Netherlands
Bydgoszcz, , Poland
Lisboa, , Portugal
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Saint Paul, Minnesota, United States
Saint Louis, Missouri, United States
Great Neck, New York, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Ramos Mejía, , Argentina
San Miguel, , Argentina
Gent, , Belgium
Manorhamilton, , Ireland
Pisa, , Italy
Reggio Emilia, , Italy
Bangkok, , Thailand
Bangkok, , Thailand
London, , United Kingdom
Salford, , United Kingdom
New York, New York, United States
Seattle, Washington, United States
La Plata, , Argentina
Leuven, , Belgium
Montréal, , Canada
Ottawa, , Canada
Rouen, , France
Berlin, , Germany
Herne, , Germany
Ioánnina, , Greece
Milan, , Italy
Taichung City, , Taiwan
Taichung, , Taiwan
Bangkok, , Thailand
Khon Kaen, , Thailand
Pathum Thani, , Thailand
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Middlesbrough, , United Kingdom
Redwood City, California, United States
San Francisco, California, United States
Mexico City, , Mexico
Ankara, , Turkey
Ankara, , Turkey
Konya, , Turkey
New Haven, Connecticut, United States
Washington, District Of Columbia, United States
Nashville, Tennessee, United States
Córdoba, , Argentina
Athens, , Greece
Dublin, , Ireland
Belgrade, , Serbia
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Beverly Hills, California, United States
New Haven, Connecticut, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Boston, Massachusetts, United States
Saint Paul, Minnesota, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Córdoba, , Argentina
San Miguel De Tucumán, , Argentina
San Miguel, , Argentina
Auchenflower, , Australia
Gent, , Belgium
Leuven, , Belgium
Montréal, , Canada
Ottawa, , Canada
Nicosia, , Cyprus
Copenhagen, , Denmark
Paris, , France
Rouen, , France
Tbilisi, , Georgia
Tbilisi, , Georgia
Göttingen, , Germany
Tuebingen, , Germany
Athens, , Greece
Athens, , Greece
Athens, , Greece
Ioánnina, , Greece
Budapest, , Hungary
Debrecen, , Hungary
Manorhamilton, , Ireland
Milan, , Italy
Roma, , Italy
Mexico City, , Mexico
Utrecht, , Netherlands
Lima, , Peru
Szczecin, , Poland
Lisboa, , Portugal
Belgrad, , Serbia
Madrid, , Spain
Sevilla, , Spain
Stockholm, , Sweden
Lugano, , Switzerland
Bangkok, , Thailand
Bangkok, , Thailand
Liverpool, , United Kingdom
Middlesbrough, , United Kingdom
Salford, , United Kingdom
Chapel Hill, North Carolina, United States
Dublin, , Ireland
Arequipa, , Peru
Lima, , Peru
Chiayi City, , Taiwan
Porto, , Portugal
Baltimore, Maryland, United States
Rozzano, , Italy
Barcelona, , Spain
Chengdu, , China
Scottsdale, Arizona, United States
East Lansing, Michigan, United States
Oklahoma City, Oklahoma, United States
Bari, , Italy
Linz, , Austria
Tel Aviv, , Israel
Roma, , Italy
Oceanside, California, United States
San Francisco, California, United States
Gainesville, Florida, United States
Ulm, , Germany
Mérida, , Mexico
łódź, , Poland
Piešťany, , Slovakia
Torino, , Italy
Burlington, Vermont, United States
Udine, , Italy
Verona, , Italy
Bunkyo Ku, , Japan
Sagamihara Shi, , Japan
Sasebo Shi, , Japan
Bunkyo Ku, , Japan
Ramat Gan, , Israel
Sapporo Shi, , Japan
Sapporo Shi, , Japan
Tokyo, , Japan
Wakayama Shi, , Japan
Nagoya, , Japan
Tsukuba Shi, , Japan
Tbilisi, , Georgia
Los Angeles, California, United States
Chicago, Illinois, United States
Summerville, South Carolina, United States
Morgantown, West Virginia, United States
Morgantown, West Virginia, United States
Wien, , Austria
Anderlecht, , Belgium
Charleroi, , Belgium
Sao Paulo, , Brazil
Edmonton, , Canada
Cangzhou, , China
Changsha, , China
Chengdu, , China
Guangzhou, , China
Guiyang, , China
Hangzhou, , China
Hangzhou, , China
Hohhot, , China
Jinan, , China
Kunming, , China
Nanchang, , China
Shanghai, , China
Shanghai, , China
Shanxi, , China
Taiyuan, , China
Wuhan, , China
Zhengzhou, , China
Tbilisi, , Georgia
Muenchen, , Germany
Haifa, , Israel
Petach Tikva, , Israel
Riga, , Latvia
Guadalajara, , Mexico
Bialystok, , Poland
Cluj Napoca, , Romania
Kemerovo, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Novosibirsk, , Russian Federation
Orenburg, , Russian Federation
St. Petersburg, , Russian Federation
Ufa, , Russian Federation
Ufa, , Russian Federation
Belgrade, , Serbia
Kragujevac, , Serbia
Kaohsiung, , Taiwan
Taoyuan, , Taiwan
Cherkassy, , Ukraine
Ternopil, , Ukraine
Zaporizhzhia, , Ukraine
Bath, , United Kingdom
Burton On Trent, , United Kingdom
Doncaster, , United Kingdom
Leeds, , United Kingdom
Newcastle, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials