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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2027
  • participants needed
    240
  • sponsor
    argenx
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Updated on 10 September 2023
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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).

Details
Condition Active Idiopathic Inflammatory Myopathy
Treatment PBO, EFG PH20 SC
Clinical Study IdentifierNCT05523167
Sponsorargenx
Last Modified on10 September 2023

Eligibility

 Yes No Not Sure

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
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)
Muscle weakness
Receiving a permitted background treatment for idiopathic inflammatory myopathy
The full list of inclusion criteria can be found in the protocol

Exclusion Criteria

A clinically significant active infection at screening
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
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
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)
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
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
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