DermatomyositisPhase 2empacificNCT06284954
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
A Phase 2 study testing Empasiprubart IV in people with Dermatomyositis and Myositis, run by argenx at 28 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatomyositis, Myositis
- What is being tested?
- Empasiprubart IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 28 sitesin 7 countries
- Study dates
- 20 Aug 2024to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
United States9 sites
Wright State Physicians Health Center
Dayton, Ohio, 45324
Omega Research Debary, LLC
DeBary, Florida, 32713
University of Florida Health (UF) - Endocrinology - Medical Specialties - Medical Plaza
Gainesville, Florida, 32610
Homestead Associates in Research, Inc.
Homestead, Florida, 33033
Life Clinical Trials
Margate, Florida, 33063
Advance Medical Research Center
Miami, Florida, 33135
Profound Research LLC
Oceanside, California, 92056
Integral Rheumatology and Immunology Specialists (IRIS)
Plantation, Florida, 33324
D and H Tamarac Research, LLC Center
Tamarac, Florida, 33321
Georgia6 sites
V.Tsitlanadze Scientific Practical Reumatology Center
Tbilisi, 0102
The First University Clinic of Tbilisi State Medical University
Tbilisi, 0141
Institute of Clinical Cardiology, Ltd
Tbilisi, 0159
Jerarsi Clinic
Tbilisi, 0167
Mtskheta street Clinic
Tbilisi, 0179
The First Medical Center
Tbilisi, 0180
Greece3 sites
National and Kapodistrian University of Athens (NKUA) - University General Hospital Attikon
Athens, 12462
Andreas Syggros Hospital of Skin and Venereal Diseases - University Dermatology and Venereology
Athens, 16121
General Hospital of Thessaloniki Papageorgiou
Thessaloniki, 56429
Poland3 sites
Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, 15707
Prywatna Praktyka Lekarska Prof. UM dr Hab. Med. Pawel Hrycaj
Poznan, 61-397
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-556
Spain3 sites
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
Hospital Quironsalud Infanta Luisa
Seville, 41010
Hospital Universitario Rio Hortega
Valladolid, 47012
Italy2 sites
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, 00128
Moldova2 sites
Timofei Mosneaga Republican Clinical Hospital
Chisinau, 2025
Institute of Cardiology
Chisinau, MD2025
About this study
Official title: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With 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).
- Conditions
- Dermatomyositis, Myositis
- Being tested
- Empasiprubart IV, Placebo IV
- Medical subject headings
- Dermatomyositis, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empasiprubart IVBiological
Also called ARGX-117
Intravenous infusion with Empasiprubart IV
Placebo IVOther
Intravenous infusion with Placebo IV
| Study group | Role | What they receive |
|---|---|---|
| Empasiprubart | Experimental | Patients receiving Empasiprubart IV Receives: Biological: Empasiprubart IV |
| Placebo | Placebo comparator | Patients receiving Placebo IV Receives: Other: Placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 90 weeks
Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE)
Measured: Up to 25 weeks
Secondary outcomes (1)
Mean TIS
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.
Measured: Up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start20 Aug 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284954
- Sponsor's protocol ID
- ARGX-117-2301
- Other IDs
- 2023-508337-14, 2023
- Acronym
- empacific
- Status last verified
- Nov 2026
- First submitted
- 22 Feb 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With Dermatomyositis
- ClinicalTrials.gov ID
- NCT06284954
- Acronym / sponsor ID
- empacific / ARGX-117-2301
- Conditions
- Dermatomyositis, Myositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empasiprubart | Experimental | Biological: Empasiprubart IVPatients receiving Empasiprubart IV |
| Placebo | Placebo comparator | Other: Placebo IVPatients receiving Placebo IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empasiprubart IVAlso: ARGX-117Intravenous infusion with Empasiprubart IV | Biological | Empasiprubart |
| Placebo IVIntravenous infusion with Placebo IV | Other | Placebo |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 90 weeks
Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE)
Time frame: Up to 25 weeks
1 secondary outcome
Mean TIS
Time frame: Up to 25 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empasiprubart IV in people with Dermatomyositis and Myositis, run by argenx at 28 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Georgia, Greece, Poland, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Up to 90 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.