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
|Condition or disease||Intervention/treatment|
|Bullous Pemphigoid||Drug: Dupilumab|
|Study Type :||Observational|
|Estimated Enrollment :||146 participants|
|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|
- 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
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
- Changes in serum anti-BP180 antibodies [ Time Frame: from 0 to 64 weeks ]
- Changes in serum anti-BP230 antibodies [ Time Frame: from 0 to 64 weeks ]
- Changes in serum total IgE [ Time Frame: from 0 to 64 weeks ]
- Changes in peripheral blood eosinophil count [ Time Frame: from 0 to 64 weeks ]
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
|Contact: Mingyue Wangemail@example.com|
|Peking University First Hospital||Recruiting|
|Beijing, Beijing, China, 100034|
|Contact: Mingyue Wang 01083573075 firstname.lastname@example.org|
|Principal Investigator:||Mingyue Wang||Peking University First Hospital|