A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus)
This study is enrolling patients with pemphigus (vulgaris or foliaceus), a condition where the immune system attacks the skin and/or mucosa (the most superficial layer that lines body cavities and passages, for example, in your mouth). Participants are invited to take place in this study if they are newly diagnosed with pemphigus or have experienced a flareup. The goal of the study is to investigate the safety, effectiveness and tolerability of a drug compound (efgartigimod PH20 SC) in adult patients aged 18 to 80 years with pemphigus.
The study will last up to 41 weeks (approximately 10 months) and will start with a screening period of up to 3 weeks. It will be followed by a study treatment period of up to 30 weeks. After the study treatment period, participants will have the choice to enter an extension of this study at week 31 and be treated with efgartigimod, or they will enter a follow-up period of 8 weeks, without treatment with study drug.
Participants may be eligible to be reimbursed for expenses such as travel costs related to study participation.
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult patients aged 18 to 80 years with PV or PF.
Patient has a clinical diagnosis of pemphigus vulgaris or pemphigus foliaceus which has been confirmed by cutaneous histology, positive direct immunofluorescence (IF), and positive indirect IF and/or ELISA.
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the
contact information above or email firstname.lastname@example.org and someone will assist you.
Your information will be shared only with the research study team for recruitment purposes and designated CTSI personnel for project quality
assurance and will remain confidential. Your information will be stored indefinitely. Should you no longer want this information to be provided
in the aforementioned ways, please contact email@example.com.