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Bullous Pemphigoid

Title A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Dupilumab In Adult Patients With Bullous Pemphigoid
Therapeutic Area Bullous Pemphigoid
Principal Investigator David Rosmarin, MD
Min Age 18 Years
Max Age 90 Years
Gender All
Contact Nicole Dumont
617 636 7462


To demonstrate that dupilumab is superior to placebo in achieving sustained remission off oral corticosteroids (OCS) in patients with bullous pemphigoid (BP)

Study Details

Inclusion Criteria

  • Patients must have clinical features of BP (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening and baseline visits.
  • Study participants are required to have histological and serological confirmation of BP by the baseline visit
  • Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥24 at baseline and screening visits.

Exclusion Criteria

  • Forms of pemphigoid other than classic BP (eg, mucous membrane-dominant BP, Brunsting-Perry cicatrial pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita, or BP with concomitant pemphigus vulgaris)
  • Patients who are receiving treatments known to cause or exacerbate BP (eg, angiotensin converting enzyme inhibitors, penicillamine, furosemide, phenacetin, dipeptidyl peptidase 4 inhibitor) who have not been on a stable dose of these medications for at least 4 weeks prior to the screening visit
  • Have ever received treatment with an IL-4 or IL-13 antagonist such as dupilumab, tralokinumab, or lebrikizumab

Study Requirements

The study consists of a 2-week screening period, a 36-week double-blind treatment period, and a 12-week follow-up period.  There will be approximately 24 visits conducted throughout the trial.