Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid

NCT ID: NCT05649579

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-01-31

Brief Summary

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This study was designed to be a retrospective, multicentre, observational study to evaluate the efficacy and safety of dupilumab in the treatment of bullous pemphigoid and to find predictors of efficacy.

Detailed Description

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Conditions

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Bullous Pemphigoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Dupilumab

Duplimab was administered according to the guidelines of the atopic dermatitis treatment regimen, which involved the first dose of 600 mg followed by 300 mg every two weeks. Because of comorbidities or the side effects of corticosteroid, some patients used dupilumab in the initial course of treatment, while others added dupilumab when the traditional drugs proved ineffective. The discontinuation was a joint decision between treating dermatologists and patients. Concomitant medicine was decided by clinicians, depending on the assessing of disease status and patients' choices, and reduced according to international guidelines.

Intervention Type DRUG

Other Intervention Names

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Dupixent

Eligibility Criteria

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Inclusion Criteria

* Adult bullous pemphigoid patients treated with dupilumab between January 1, 2021, and July 31, 2022, at six leading dermatology departments in the Chinese Collaborative Network for Autoimmune Bullous Diseases.
* The diagnosis of BP requires clinical manifestations and immunological or pathological evidences.
* Dupilumab treatment should continue for at least 4 weeks and possibly longer.

Exclusion Criteria

* Drug-induced BP, γ-1 pemphigoid
* Patients with less than 4 weeks of follow-up
* Patients were given any other biologicals within 6 months before the first dupilumab administration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Shandong Provincial Institute of Dermatology and Venereology

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mingyue WANG

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingyue Wang

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2022Y446

Identifier Type: -

Identifier Source: org_study_id