BULLOUS PEMPHIGOID
Conditions
Interventions
investigational material(s)
Generic name etc : Dupilumab
INN of investigational material : Dupilumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for I
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must have 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 histological and serological confirmation of BP by the baseline visit. - 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.
Exclusion criteria
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. - Treatment with systemic corticosteroids within 2 weeks before the baseline visit - Treatment with topical corticosteroids of medium potency or higher, topical calcineurin inhibitor, or topical crisaborole within 1 week 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Proportion of patients achieving sustained remission [ Time Frame: Week 36 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1.Total cumulative dose of OCS [ Time Frame: Baseline to week 36 ] 2.Percent change in weekly average of daily peak pruritus numerical rating score (NRS) [ Time Frame: Baseline to week 36 ] 3.Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS >=4 [ Time Frame: Baseline to week 36 ] 4.Percent change in BPDAI activity score [ Time Frame: Baseline to week 36 ] | — |
Countries
Europe, Japan, North America
Outcome results
None listed