Active Idiopathic Inflammatory MyopathyPhase 2/3ALKIVIANCT05523167
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
A Phase 2/3 study testing EFG PH20 SC and PBO in people with Active Idiopathic Inflammatory Myopathy and Myositis, run by argenx at 202 sites in 36 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Idiopathic Inflammatory Myopathy, Myositis, Dermatomyositis
- What is being tested?
- EFG PH20 SC and PBO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 202 sitesin 36 countries
- Study dates
- 12 Oct 2022to 2 Jul 2026
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
- 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
- Participant is pregnant or lactating or intends to become pregnant during the study.
Trial locations and contacts
202 sites in 36 countries.
202 sites in 36 countries
United States40 sites
Emory University Hospital, The Emory Clinic
Atlanta, Georgia, 30322
Augusta University
Augusta, Georgia, 30312
Austin Neuromuscular Center
Austin, Texas, 78759
Johns Hopkins Medicine - Johns Hopkins Myositis Center
Baltimore, Maryland, 21224
Attune Health Research, Inc
Beverly Hills, California, 90039
Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)
Boston, Massachusetts, 02115-6110
University of Vermont Medical Center - Main Campus
Burlington, Vermont, 05401
University of North Carolina (UNC) School of Medicine
Chapel Hill, North Carolina, 27514-4220
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43201
Denver Arthritis Clinic
Denver, Colorado, 80230
Michigan State University - Neurology
East Lansing, Michigan, 48824
UF Health Rheumatology
Gainesville, Florida, 32610-3008
Northwell Health
Great Neck, New York, 11021
McGovern Medical School -The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Nerve And Muscle Center Of Texas
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
University Of Kansas Medical Center
Kansas City, Kansas, 66160
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
Nashville, Tennessee, 37232-0028
Yale Cancer Center-Yale University School Of Medicine
New Haven, Connecticut, 06520
Hospital for Special Surgery
New York, New York, 10021
Profound Research LLC - Oceanside
Oceanside, California, 92056
Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
Oklahoma City, Oklahoma, 73120
University of California, Irvine
Orange, California, 92868
Neuromuscular Research Center
Phoenix, Arizona, 85028
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15261
Oregon Health and Science University
Portland, Oregon, 97239
Eisenhower Medical Center
Rancho Mirage, California, 92270
Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
Redwood City, California, 94063-3132
St. Paul Rheumatology, PA
Saint Paul, Minnesota, 55121
California Pacific Medical Center - Sutter Health
San Francisco, California, 94109
Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)
San Francisco, California, 94143-2202
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
Scottsdale, Arizona, 85251
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
Tampa, Florida, 33616
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
China20 sites
Peking University First Hospital
Beijing, 100034
Peking University Third Hospital
Beijing, 100191
Peking Union Medical College Hospital
Beijing, 100730
The First Hospital of Jilin University
Changchun, 130021
Xiangya Hospital Central South University
Changsha, 410008
The Second Xiangya Hospital of Central South University
Changsha, 410011
Sichuan Provincial Peoples Hospital
Chengdu, 610072
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510000
Nanfang Hospital, Southern Medical University
Guangzhou, 510515
The First Affiliated Hospital - School of Medicine - ZheJiang University
Hangzhou, 310003
Anhui Provincial Hospital
Hefei, 230001
The Second Affiliated Hospital Of Nanchang University
Nanchang, 330000
Nanjing Drum Tower Hospital
Nanjing, 210008
Huashan Hospital Affiliated to Fudan University
Shanghai, 200000
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Shanghai Renji Hospital
Shanghai, 200127
First Affiliated Hospital of Shanxi Medical College
Shanxi, 30001
China Medical University (CMU) - First Affiliated Hospital
Shenyang, 110001
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
Wuhan, 430030
First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
Zhengzhou, 450052
Japan18 sites
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Bunkyō City, 113-8519
Nippon Medical School - Nippon Medical School Hospital
Bunkyō City, 113-8603
St. Marianna University School of Medicine Hospital
Kawasaki, 216-8511
Kurume University Hospital
Kurume, 830-0011
Chiba-Nishi General Hospital
Matsudo-shi, 270-2251
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, 457-8510
Kitasato University Hospital (KUH)
Sagamihara-shi, 252-0375
Sapporo City Hospital
Sapporo, 060-8604
Hokkaido University Hospital - Rheumatology
Sapporo, 060-8648
Sasebo Chuo Hospital
Sasebo-shi, 857-1165
Tohoku University Hospital
Sendai, 980-8574
Tokushima University Hospital
Tokushima, 770-8503
Juntendo University Hospital - Rheumatology
Tokyo, 113-8431
The University of Tokyo Hospital
Tokyo, 113-8655
Keio University Hospital
Tokyo, 160-8582
University of Tsukuba Hospital - Rheumatology
Tsukuba, 305-8576
Yamaguchi University Hospital
Ube-shi, 755-8505
Wakayama Medical University Hospital - Dermatology
Wakayama, 641-8509
Italy12 sites
Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
Bari, 70124
Azienda Ospedaliero Universitaria Careggi
Florence, 50139
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
Milan, 20132
San Matteo Hospital
Pavia, 27100
A.O. Universitaria Pisana
Pisa, 56126
IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, 00168
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, 00189
IRCCS Istituto Clinico Humanitas - Rheumatology
Rozzano, 20089
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
Torino, 10126
ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia
Udine, 33100
Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, 37134
Germany10 sites
Charite - Universitaetsmedizin Berlin
Berlin, 10117
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
Universitatsmedizin Gottingen - Georg-August-Universitat
Göttingen, 37075
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Rheumazentrum Ruhrgebiet
Herne, 44649
Universitatsmedizin Mannheim
Mannheim, 68167
Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
München, 80336
St. Josef-Stift Sendenhorst
Sendenhorst, 48324
Universitaetsklinikum Tuebingen (UKT)
Tübingen, 72076
Universitatsklinikum Ulm - Standort Oberer Eselsberg
Ulm, 89081
Spain9 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario Ramon y Cajal
Madrid, 28034
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario 12 de Octubre
Madrid, 451086
Hospital De Valme
Seville, 9-41014
Hospital Universitario y Politecnico La Fe
Valencia, 46026
Hospital Do Meixoeiro
Vigo, 36200
United Kingdom9 sites
Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG
Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
Doncaster, DN2 5LT
Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
Leeds, LS7 4SA
Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
Liverpool, L9 7AL
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London, NW3 2QG
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Salford, M6 8HD
Thailand7 sites
Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
Bangkok, 10300
Phramongkutklao Hospital
Bangkok, 10400
Ramathibodi hospital
Bangkok, 10400
Siriraj Hospital, Mahidol University of Internal medicine
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Chiang Mai, 50200
Khon Kaen University
Khon Kaen, 40000
Thammasat University Hospital
Pathum Thani, 12120
Georgia6 sites
American Hospital Network
Tbilisi, 0102
LTD New Hospitals
Tbilisi, 0114
Aversi Clinic
Tbilisi, 0160
LLC MediClub Georgia
Tbilisi, 0179
The First Medical Center
Tbilisi, 0180
LTD Tbilisi Heart Center
Tbilisi, 0186
South Korea6 sites
Chungnam National University Hospital (CNUH)
Daejeon, 35015
Gachon University Gil Medical Center
Incheon, 21565
Kyung Hee University Medical Center
Seoul, 02447
Seoul National University Hospital
Seoul, 03080
Hanyang University Seoul Hospital
Seoul, 04763
Ajou University Hospital
Suwon, 16499
Argentina5 sites
Consultora Integral de Salud
Córdoba, 5000
Framingham Centro Medico
La Plata, B1902COS
Dim Clinica Privada
Ramos Mejía, B1704ETD
Centro Dermatologico Schejtman
San Miguel, B1663GKT
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, T4000AXL
Greece5 sites
National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
Athens, 115 27
National and Kapodistrian University of Athens - Eginition Hospital
Athens, 115 28
Attikon General University Hospital
Athens, 12462
Athens Medical Center
Athens, 151 25
University of Ioannina Medical School
Ioannina, 45110
Israel5 sites
Bnai Zion Medical Center
Haifa, 31048
Rambam Health Care Campus
Haifa, 3109601
Meir Medical Center
Kfar Saba, 44281
Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
Petah Tikva, 49100
Sheba Medical Center - Rheumatology
Ramat Gan, 52621
Belgium4 sites
Centre Hospitalier Universitaire de Charleroi
Charleroi, 6042
AZ Sint Lucas Gent-Campus Sint Lucas
Ghent, 9000
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, 3000
Centre Hospitalier Universitaire Sart Tilman
Liège, 4000
France4 sites
Hopital Edouard Herriot
Lyon, 69003
Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
Paris, 75013
Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
Rouen, 76031
Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
Strasbourg, 67098
Peru4 sites
Hogar Clinica San Juan de Dios
Arequipa, 4018
Investigaciones Clinicas S.A.C.
Lima, 15023
Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar
Lima, 27
Hospital Nacional Cayetano Heredia
Lima, 31
Ireland3 sites
St. Vincents University Hospital
Dublin, D04 T6F4
Connolly Hospital Blanchardstown
Dublin, D15 X40D
North West Rheumatology Unit - Our Lady's Hospital
Manorhamilton, F91 X012
Poland3 sites
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
Lodz, 90-549
Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, 71-252
Taiwan3 sites
Chung Shan Medical University Hospital
Taichung, 402
China Medical University and Hospital
Taichung, 40402
Taichung Veterans General Hospital
Taichung, 40705
Turkey (Türkiye)3 sites
Ankara University Medical Faculty
Ankara, 06230
Ankara City Hospital
Ankara, 06800
Necmettin Erbakan University Meram Medical Faculty
Konya, 42090
Australia2 sites
The Wesley Medical Research
Auchenflower, 4066
Fiona Stanley Hospital
Murdoch, 6150
Austria2 sites
Medical University Innsbruck
Innsbruck, 6020
Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
Vienna, 1090
Bulgaria2 sites
Medical Centre Artmed
Plovdiv, 4002
Multiprofile hospital for active treatment Kaspela EOOD
Plovdiv, 4002
Canada2 sites
Genge Partners
Montreal, H4A 3T2
Ottawa Hospital Research Institute-Civic Campus
Ottawa, K1Y 4E9
Hungary2 sites
Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
Budapest, 1083
Debreceni Egyetem - University of Debrecen
Debrecen, 4032
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50161
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
Mexico2 sites
Centro Peninsular De Investigacion Clinica
Mérida, 97000
CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
Mexico City, 06700
Netherlands2 sites
Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
Amsterdam, 1105 AZ
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, 3584 CX
Portugal2 sites
Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria
Lisbon, 1649-035
Centro Hospitalar Universitario de Santo Antonio
Porto, 4099-001
Serbia2 sites
Clinical Center of Serbia
Belgrade, 11000
Institute of Rheumatology
Belgrade, 11000
Denmark1 site
Copenhagen University Hospital-Rigshospitalet University Hospital
Copenhagen, 2100
About this study
Official title: A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
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).
- Conditions
- Active Idiopathic Inflammatory Myopathy, Myositis, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy, Antisynthetase Syndrome
- Being tested
- EFG PH20 SC, PBO
- Medical subject headings
- Myositis, Dermatomyositis, Polymyositis, Antisynthetase syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFG PH20 SCBiological
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
PBOOther
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
| Study group | Role | What they receive |
|---|---|---|
| EFG PH20 SC | Experimental | participants receiving efgartigimod PH20 SC on top of background treatment Receives: Biological: EFG PH20 SC |
| PBO PH20 SC | Placebo comparator | participants receiving placebo PH20 SC on top of background treatment Receives: Other: PBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean TIS
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Measured: phase 2: 24 weeks; phase 3: 52 weeks
Secondary outcomes (10)
Time to reach TIS ≥ 20 (first "minimal clinical improvement")
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Measured: phase 2: up to 24 weeks; phase 3: up to 52 weeks
Percentage of participants with TIS ≥ 20
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Measured: phase 2: up to 24 weeks; phase 3: up to 52 weeks
Time to reach TIS ≥ 40 (first "moderate clinical improvement")
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Measured: phase 2: up to 24 weeks; phase 3: up to 52 weeks
Percentage of participants with TIS ≥ 40
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Measured: phase 2: up to 24 weeks; phase 3: up to 52 weeks
Change in MMT8 score
The manual muscle testing-8 (MMT8) is a physician assessment of muscle strength in a set of 8 designated muscles tested bilaterally and axially. The highest total potential MMT8 score is 150
Measured: phase 2: up to 24 weeks; phase 3: up to 52 weeks
Change in Patient Global Assessment of Disease Activity (PGA)
The Patient Global Assessment of Disease Activity (PGA) is a tool that measures a patient's global evaluation of their overall disease activity at the time of assessment using a 10-cm VAS. The participant rates their overall disease activity by drawing a vertical mark on a 10-cm VAS from the left end of the line (no evidence of disease activity) to the right end of the line (extremely active or severe disease activity).
Measured: phase 2: up to 24 weeks; phase 3: up to 52 weeks
Change in Physician Global Assessment of Disease Activity (MDGA)
The Physician Global Assessment of Disease Activity (MDGA) is a tool that measures the physician's global evaluation of the participant's overall disease activity, defined as potentially reversible pathology or physiology resulting from IIM. The physician rates disease activity on the MDGA using a 10-cm VAS. Overall disease activity is rated by drawing a vertical mark on a 10-cm VAS from the left end of the line (no evidence of disease activity), midpoint of the line (moderate disease activity), and the right end of the line (extremely active or severe disease activity).
Measured: phase 2: up to 24 weeks; phase 3: up to 52 weeks
Proportion of participants who have at least moderate improvement (≥40) in TIS at week 52 and adhere to an oral prednisone dosage of ≤5 mg/day (or equivalent) from week 44 onward
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Measured: Phase 3: up to 52 weeks
Change in CK abnormality grades at week 52
CK: creatine kinase
Measured: Phase 3: up to 52 weeks
Change in CDASI activity score at week 52
The Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) is a skin-specific outcome measure used to assess disease in patients with Dermatomyositis (DM). Disease in 15 different anatomical locations is rated using 3 activity measures (erythema, scale, erosion/ulceration) and 2 damage measures (poikiloderma, calcinosis). The resulting activity and damage scores range from 0 to 100 and 0 to 32, respectively. Higher scores indicate greater disease severity.
Measured: Phase 3: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start12 Oct 2022
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Idiopathic Inflammatory MyopathyStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523167
- Sponsor's protocol ID
- ARGX-113-2007
- Other IDs
- 2024-512785-33-00
- Acronym
- ALKIVIA
- Status last verified
- Jul 2026
- First submitted
- 30 Aug 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No