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Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05649579
Recruitment Status : Recruiting
First Posted : December 14, 2022
Last Update Posted : December 14, 2022
Sponsor:
Collaborators:
Ruijin Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
West China Hospital
Second Xiangya Hospital of Central South University
Shandong Provincial Institute of Dermatology and Venereology
Information provided by (Responsible Party):
Mingyue WANG, Peking University First Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Bullous Pemphigoid Drug: Dupilumab

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Study Type : Observational
Estimated Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid: a Multicenter Retrosepctive Study
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus
Drug Information available for: Dupilumab


Intervention Details:
  • Drug: 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.
    Other Name: Dupixent


Primary Outcome Measures :
  1. Proportion of patients reached disease control [ Time Frame: within 4 weeks ]
    Disease control was defined as the point at which new lesions or pruritic symptoms cease to form and existing lesions start to heal.


Secondary Outcome Measures :
  1. Complete remission rate [ Time Frame: within 64 weeks ]
    Complete remission is defined as the absence of new or established lesions or pruritus while the patient is receiving minimal therapy or off therapy for at least 2 months.

  2. Relapse rate [ Time Frame: within 64 weeks ]
    Relapse was defined as the appearance of three or more new lesions a month or at least one eczematous lesion with a diameter >10cm or urticarial plaque that does not heal within one week, or the extension of established lesions or daily pruritus in a patient who has achieved disease control.

  3. Adverse events [ Time Frame: within 64 weeks ]
    Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.

  4. Changes in BPDAI scores [ Time Frame: from 0 to 64 weeks ]
    Disease severity was assessed using the bullous pemphigoid disease area index (BPDAI) score and was classified into mild (BPDAI≤19), moderate (20≤BPDAI≤56), and severe (BPDAI≥57).

  5. Changes in itching NRS scores [ Time Frame: from 0 to 64 weeks ]
    Pruritus was evaluated via itching numeric rating scale (NRS), ranging from 0 (no itch) to 10 points (worst imaginable itch).

  6. Changes in serum anti-BP180 antibodies [ Time Frame: from 0 to 64 weeks ]
  7. Changes in serum anti-BP230 antibodies [ Time Frame: from 0 to 64 weeks ]
  8. Changes in serum total IgE [ Time Frame: from 0 to 64 weeks ]
  9. Changes in peripheral blood eosinophil count [ Time Frame: from 0 to 64 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05649579


Contacts
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Contact: Mingyue Wang 01083573075 mywang@pku.edu.cn

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Mingyue Wang    01083573075    mywang@pku.edu.cn   
Sponsors and Collaborators
Peking University First Hospital
Ruijin Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
West China Hospital
Second Xiangya Hospital of Central South University
Shandong Provincial Institute of Dermatology and Venereology
Investigators
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Principal Investigator: Mingyue Wang Peking University First Hospital
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Responsible Party: Mingyue WANG, Principal Investigator, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT05649579    
Other Study ID Numbers: 2022Y446
First Posted: December 14, 2022    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases