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(352) 733-0111

ARGX-113-2011

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.

Details

Full study title A Phase 3, Single-Arm, Multi center, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Idiopathic Inflammatory Myopathy
Protocol number OCR45214
ClinicalTrials.gov ID NCT05979441
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Has completed trial ARGX-113-2007

  • Being capable of providing signed informed consent and complying with protocol requirements

  • Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the investigational medicinal product

Exclusion Criteria:

  • Intention to have major surgery during the study period; or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk

  • Known hypersensitivity reaction to investigational medicinal product or 1 of its excipients Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness

  • Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit

  • Diagnosis with a deselected subtype of myositis based on the analysis of the phase 2 stage data in ARGX-113-2007, unless the investigator determines that the participant is benefiting from IMP as defined by a score of "much better" or "moderately better" on the 'Clinical Global Impression of Change' and 'Patient Global

  • Impression of Change' assessments for at least 12 weeks, and that enrolling in the study is in the participant's best interest

Lead researcher

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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