CompletedPhase 2/3

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

United States, Australia, France106 participantsStarted 2020-10-28

Plain-language summary

The main purpose of this study is to investigate whether dupilumab is effective and safe for the treatment of bullous pemphigoid. Dupilumab is a type of drug called a "monoclonal antibody". An antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses. Bullous pemphigoid is an autoimmune subepidermal blistering disease, predominately affecting the elderly (typical onset after age 60). The study is looking at several other research questions, including: * Side effects that may be experienced by people taking dupilumab * How dupilumab works in the body and affects the body * How dupilumab affects quality of life * How much dupilumab is present in the blood * To see if dupilumab works to wean the patient off oral corticosteroids

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Tr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is completed and was measuring whether dupilumab could help patients reach sustained remission by Week 36, has the final data been published, and what did the results show about how well it actually worked for bullous pemphigoid?
2Dupilumab is already approved for conditions like eczema — does the completed data from this Phase 2/3 trial suggest it might now be approved or used off-label for bullous pemphigoid, and would it be an option worth considering in my case?
3The trial focused on 'sustained remission' as the key goal — can you explain what that means in practical terms for someone with bullous pemphigoid, and how does that compare to what current standard treatments like corticosteroids can realistically achieve for me?
4Because this was a Phase 2/3 trial, what do we know so far about the safety profile of dupilumab specifically in bullous pemphigoid patients, and are there any risks I should weigh against my current treatment options?
5Given that this trial has already completed, is there any way I could access dupilumab for my bullous pemphigoid now — through an approved indication, a compassionate use program, or another ongoing study — and do you think it would be appropriate to explore that path?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of Participants Achieving Sustained Remission at Week 36

Timeframe: At Week 36

Trial details

NCT IDNCT04206553

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-12

Results submitted2026-01-02

View on ClinicalTrials.gov More Bullous Pemphigoid trials