En undersøgelse af Empasiprubarts effekt på kroppen, niveauer i blodet, effektivitet og sikkerhed hos voksne med dermatomyositis (empacific)
2. november 2026 opdateret af: argenx
En fase 2, randomiseret, dobbeltblindet, placebokontrolleret, multicenterundersøgelse til evaluering af sikkerheden, tolerabiliteten og effektiviteten af multiple dosisregimer af Empasiprubart hos voksne med dermatomyositis
This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM).
The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
3
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Oceanside, California, Forenede Stater, 92056
- Profound Research LLC
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Florida
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DeBary, Florida, Forenede Stater, 32713
- Omega Research Debary, LLC
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Gainesville, Florida, Forenede Stater, 32610
- University of Florida Health (UF) - Endocrinology - Medical Specialties - Medical Plaza
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Homestead, Florida, Forenede Stater, 33033
- Homestead Associates in Research, Inc.
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Margate, Florida, Forenede Stater, 33063
- Life Clinical Trials
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Miami, Florida, Forenede Stater, 33135
- Advance Medical Research Center
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Plantation, Florida, Forenede Stater, 33324
- Integral Rheumatology and Immunology Specialists (IRIS)
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Tamarac, Florida, Forenede Stater, 33321
- D and H Tamarac Research, LLC Center
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Ohio
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Dayton, Ohio, Forenede Stater, 45324
- Wright State Physicians Health Center
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Tbilisi, Georgien, 0141
- The First University Clinic of Tbilisi State Medical University
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Tbilisi, Georgien, 0167
- Jerarsi Clinic
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Tbilisi, Georgien, 0179
- Mtskheta street Clinic
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Tbilisi, Georgien, 0180
- The First Medical Center
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Tbilisi, Georgien, 0159
- Institute of Clinical Cardiology, Ltd
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Tbilisi, Georgien, 0102
- V.Tsitlanadze Scientific Practical Reumatology Center
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Athens, Grækenland, 12462
- National and Kapodistrian University of Athens (NKUA) - University General Hospital Attikon
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Athens, Grækenland, 16121
- Andreas Syggros Hospital of Skin and Venereal Diseases - University Dermatology and Venereology
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Thessaloniki, Grækenland, 56429
- General Hospital of Thessaloniki Papageorgiou
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Pisa, Italien, 56126
- Azienda Ospedaliera Universitaria Pisana
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Rome, Italien, 00128
- Fondazione Policlinico Universitario Campus Bio-Medico
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Chisinau, Moldova, MD2025
- Institute of Cardiology
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Chisinau, Moldova, 2025
- Timofei Mosneaga Republican Clinical Hospital
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Bialystok, Polen, 15707
- Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
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Poznan, Polen, 61-397
- Prywatna Praktyka Lekarska Prof. UM dr Hab. Med. Pawel Hrycaj
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Wroclaw, Polen, 50-556
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
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Barcelona, Spanien, 08003
- Parc de Salut Mar - Hospital del Mar
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Seville, Spanien, 41010
- Hospital Quironsalud Infanta Luisa
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Valladolid, Spanien, 47012
- Hospital Universitario Rio Hortega
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Is at least 18 years of age and the local legal age of consent for clinical studies when signing the Informed Consent Form
- Is capable of providing signed informed consent and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before receiving the study drug
- Has a clinical diagnosis of dermatomyositis or juvenile dermatomyositis. The diagnosis date for juvenile dermatomyositis should be ≤5 years before screening
- Has active muscle disease associated with classic dermatomyositis or juvenile dermatomyositis at screening and before the first study drug adminisitration and at least 1 of the following: elevated levels of creatine kinase, aldolase, lactate dehydrogenase, aspartate aminotransaminase or alanine aminotransferase at screening; or electromyography ≤18 weeks before the first study drug administration; or an MRI depicting active muscle inflammation ≤18 weeks before the first study drug administration; or muscle biopsy demonstrating signs of active inflammation ≤18 weeks before the first study drug administration
- Has at least mild skin disease at screening
- Complies with the permitted background dermatomyositis treatment requirements at screening
- Has had immunization with the first meningococcal, pneumococcal, and the single Haemophilus influenza type B vaccine ≥14 days before the first study drug administration
Exclusion Criteria:
- Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of dermatomyositis or puts the participant at undue risk
- Naïve to standard dermatomyositis treatment according to local recommendations
- History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first study drug administration. 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 findings of prostate cancer
- Clinically significant active infection that is not sufficiently resolved before the first study drug administration in the investigator's opinion
- Positive serum test at screening for active infection with any of the following: Hepatitis B virus, Hepatitis C virus, HIV
- Clinically significant disease, recent major surgery, or intention to have major surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Current participation in another interventional clinical study
- Known hypersensitivity to the study drug or any of its excipients
- History (within 12 months before screening) of or current alcohol, drug, or medication abuse, as assessed by the investigator
- Pregnant or lactating state or intending to become pregnant during the study
- Previous participation in an empasiprubart clinical study with at least 1 dose of study drug received
- Known complement component deficiency as assessed by the investigator
- Change in dermatomyositis physical therapy or exercise program from ≤4 weeks before screening
- Inflammatory or non-inflammatory myopathies other than dermatomyositis, such as drug-induced or endocrine-induced myositis, infective myositis, polymyositis, immune-mediated necrotizing myopathy, inclusion body myositis, overlap myositis, metabolic myopathies, or muscle dystrophies
- Paraneoplastic dermatomyositis secondary to malignancy
- Glucocorticoid-induced myopathy
- Severe muscle damage
- Extensive or severe calcinosis
- Interstitial lung disease with at least 1 of the following: forced vital capacity (FVC) ≤60%; supplemental oxygen therapy; rapidly progressing uncontrolled interstitial lung disease; moderate or severe interstitial lung disease
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Empasiprubart
Patients receiving Empasiprubart IV |
Intravenous infusion with Empasiprubart IV
Andre navne:
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Placebo komparator: Placebo
Patients receiving Placebo IV |
Intravenous infusion with Placebo IV |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Forekomst af bivirkninger (AE'er)
Tidsramme: Op til 90 uger
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Op til 90 uger
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Procentdel af deltagere, der afbryde forsøgsmedicin (IMP) på grund af en uønsket hændelse (AE)
Tidsramme: Op til 25 uger
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Op til 25 uger
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mean TIS
Tidsramme: Up to 25 weeks
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The Total Improvement Score (TIS) assesses minimal, moderate, and major clinical response categorically or continuously using American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) criteria. |
Up to 25 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. august 2024
Primær færdiggørelse (Anslået)
1. november 2026
Studieafslutning (Anslået)
1. november 2026
Datoer for studieregistrering
Først indsendt
22. februar 2024
Først indsendt, der opfyldte QC-kriterier
22. februar 2024
Først opslået (Faktiske)
29. februar 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ARGX-117-2301
- 2023-508337-14 (Anden identifikator: CTIS number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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