Bullous PemphigoidNCT05649579
Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid
An observational study of Bullous Pemphigoid, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- Dupilumab
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid: a Multicenter Retrosepctive Study
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.
- Conditions
- Bullous Pemphigoid
- Being tested
- Dupilumab
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reached disease control
Disease control was defined as the point at which new lesions or pruritic symptoms cease to form and existing lesions start to heal.
Measured: within 4 weeks
Secondary outcomes (9)
Complete remission rate
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.
Measured: within 64 weeks
Relapse rate
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.
Measured: within 64 weeks
Adverse events
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.
Measured: within 64 weeks
Changes in BPDAI scores
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).
Measured: from 0 to 64 weeks
Changes in itching NRS scores
Pruritus was evaluated via itching numeric rating scale (NRS), ranging from 0 (no itch) to 10 points (worst imaginable itch).
Measured: from 0 to 64 weeks
Changes in serum anti-BP180 antibodies
Measured: from 0 to 64 weeks
Changes in serum anti-BP230 antibodies
Measured: from 0 to 64 weeks
Changes in serum total IgE
Measured: from 0 to 64 weeks
Changes in peripheral blood eosinophil count
Measured: from 0 to 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Chinese Academy of Medical Sciences, West China Hospital, Second Xiangya Hospital of Central South University, Shandong Provincial Institute of Dermatology and Venereology
- Responsible party
- Principal investigator, Mingyue WANG, Peking University First Hospital
- Investigators
- Mingyue Wang, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649579
- Sponsor's protocol ID
- 2022Y446
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid: a Multicenter Retrosepctive Study
- ClinicalTrials.gov ID
- NCT05649579
- Acronym / sponsor ID
- 2022Y446
- Conditions
- Bullous Pemphigoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Chinese Academy of Medical Sciences, West China Hospital, Second Xiangya Hospital of Central South University, Shandong Provincial Institute of Dermatology and Venereology
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DupixentDuplimab 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. | Drug | – |
Primary outcome
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.
9 secondary outcomes
Complete remission rate
Time frame: within 64 weeks
Relapse rate
Time frame: within 64 weeks
Adverse events
Time frame: within 64 weeks
Changes in BPDAI scores
Time frame: from 0 to 64 weeks
Changes in itching NRS scores
Time frame: from 0 to 64 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Active, not recruitingObservational study
Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC)
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RecruitingObservational study
Autoimmune Blistering Diseases Study
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Not yet recruitingPhase 3
Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingyue Wang principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bullous Pemphigoid, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reached disease control (time frame: within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.