A Phase 2/3 Randomized Double-Blinded Placebo-Controlled Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Bullous Pemphigoid
  • Age: Between 18 - 90 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. The participant is willing and able to: a) understand the requirements of the study, b) provide written informed consent (including consent for the use and disclosure of research-related health information), and c) comply with the study protocol procedures (including required study visits).
    2. The participant is male or female, and aged =18 years at the time of signing the informed consent form (ICF).
    3. Participants have clinical signs of BP (ie, presence of bullae), with or without the presence of urticarial/eczematous/erythematous plaques or pruritus.
    4. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not be eligible for this study if the following are true:

    1. Current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse.
    2. Pregnant or lactating females and those who intend to become pregnant during the study.
    3. Clinically significant uncontrolled active or chronic, bacterial, viral, or fungal infection.
    4. Participant has other forms of pemphigoid (including but not limited to pemphigoid gestationis, drug-induced BP that resolves after culprit-drug withdrawal, anti-p200 pemphigoid, mucous membrane pemphigoid, and cicatricial pemphigoid), or other AIBDs (including but not limited to epidermolysis bullosa acquisita, pemphigus vulgaris, and exfoliative erythroderma).
    5. Participant Received unstable dose of treatments known to cause or exacerbate BP (eg, angiotensin converting enzyme inhibitors, penicillamine, furosemide, phenacetin, dipeptidyl peptidase 4 inhibitor) for at least 4 weeks prior to the baseline visit.
    6. Use of BP treatments other than OCS, topical corticosteroids, conventional immunosuppressants.
    7. Known contraindication to OCS therapy.
    8. History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for =3 years before the first administration of the IMP. Participants with the following cancers can be included at any time, provided they are adequately treated prior to their participation in the study: a) Basal cell or squamous cell skin cancer, b) Carcinoma in situ of the cervix, c) Carcinoma in situ of the breast, and d) Incidental histological finding of prostate cancer (tumor-node metastasis [TNM] stage T1a or T1b).



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