A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

• Status: Recruiting
• Trial end date: 2023-09-15
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to demonstrate that dupilumab is superior to placebo in achieving sustained remission off oral corticosteroids (OCS) in patients with bullous pemphigoid (BP).

The secondary objectives of the study are:

• To evaluate the OCS-sparing effects of dupilumab in patients with BP

• To evaluate the effect of dupilumab on itch in patients with BP

• To evaluate the effects of dupilumab on health-related quality of life measures in patients with BP

• To evaluate the effect of dupilumab in circulating BP180 and BP230 autoantibody titers

• To assess the safety and tolerability of dupilumab administered to patients with BP

• To characterize the trough concentrations of functional dupilumab over time following administration of dupilumab in patients with BP

• To assess the immunogenicity of dupilumab in patients with BP over time

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Antibodies, Monoclonal

Criteria

Key Inclusion Criteria:

• Patients must have characteristic clinical features of bullous pemphigoid (BP) (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening and baseline visits.

• Study participants are required to have a confirmed diagnosis of BP based on histopathology, immunopathology, and serology at the baseline visit, as defined in the protocol.

• Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥24 at baseline and screening visits.

• Baseline peak pruritus NRS score for maximum itch intensity ≥4

• Karnofsky performance status score ≥50% at the screening visit.

Key Exclusion Criteria:

• Forms of pemphigoid other than classic BP (eg, Brunsting-Perry cicatricial 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.

• Treatment with systemic corticosteroids within 7 days before the baseline visit

• Treatment with topical corticosteroids of medium potency or higher, topical calcineurin inhibitor, or topical crisaborole within 7 days before the baseline visit

• Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit.

• Treatment with BP-directed biologics as follows:

• Any cell-depleting agents including but not limited to rituximab: within 12 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer

• Other biologics (such as IL-5 inhibitors benralizumab or mepolizumab): within 5 half-lives (if known) or 16 weeks prior to the baseline visit, whichever is longer

• Intravenous immunoglobulin within 16 weeks prior to the baseline visit

NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply