Bullous PemphigoidNCT06561256
JAK Inhibitors' Efficacy in Bullous Pemphigoid
An observational study of Bullous Pemphigoid and Janus Kinase Inhibitor, run by Chao Ji at 1 site in China.
Trial summary
Bullous pemphigoid (BP) is an autoimmune subepidermal blistering skin disease that predominantly affects the elderly population, with rare cases reported in children and adolescents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bullous Pemphigoid, Janus Kinase Inhibitor, Corticosteroids
- What is being tested?
- Janus Kinase Inhibitor
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Jul 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All enrolled patients will be followed for a duration of 48 weeks. This study will include approximately 300 patients with moderate to severe BP. The Primary outcomes were the time to cease of new lesions, time to achieve minimal therapy, the cumulative amount of corticosteroids (at the time of achieving minimal therapy). The Secondary outcomes were the scores of BPDAI (week 0, week 2, and week 4). the scores of itching Numeric Rating Scale (NRS) (week 0, week 2, and week 4). the level of IgE (week 0, week 2) and eosinophil percentage (Eos%) (week 0, week 2). the clinical remissions at week 24 and week 48. Adverse events: all treatment-related adverse events (AEs) were assessed.
Who may be able to join
- Diagnosis of Bullous pemphigoid;
- Moderate to severe bullous pemphigoid； The disease severity was measured using the Bullous Pemphigoid Disease Area Index (BPDAI) score and was classified into mild (BPDAI ≤ 19), moderate (20 ≤ BPDAI ≤ 56), and severe (BPDAI ≥ 57).
- Moderate to severe BP received JAK Inhibitors combination with corticosteroids therapy；
Who cannot join
- Patients diagnosed with malignant neoplasms
- Previous administration with biologics within 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fujian, Fuzhou, 350000
About this study
Official title: Effectiveness and Safety of Combination Therapy With Corticosteroids and JAK Inhibitors in Bullous Pemphigoid
Bullous pemphigoid (BP) is an autoimmune subepidermal blistering skin disease that predominantly affects the elderly population, with rare cases reported in children and adolescents. BP is characterized by circulating antibodies that target the hemidesmosomal proteins bullous pemphigoid Antigen 1 (BPAg1 or BP230) and bullous pemphigoid Antigen 2 (BPAg2 or BP180/collagen XVII) located at the dermal-epidermal junction. The first-line treatment of BP includes topical or systemic use of corticosteroids. For refractory cases or when corticosteroids are contraindicated or to minimize adverse effects, adjunct therapies such as immunosuppressants (e.g. azathioprine, cyclosporine), dapsone, tetracycline antibiotics combined with niacinamide, intravenous immunoglobulins (IVIG), and plasma exchange are employed. Recent research has explored the use of biologic agents to treat refractory BP, including anti-CD20 monoclonal antibodies, anti-IgE monoclonal antibodies, and anti-interleukin monoclonal antibodies, showing promising outcomes. Nevertheless, effectively managing BP remains a challenge.
The Janus kinase (JAK)-signal transducer and activator of transcription (STAT) pathway has been implicated as a key driver in many inflammatory diseases. Recently, a class of drugs targeting this pathway, known as JAK inhibitors, has been developed. Some studies have investigated the efficacy and safety of JAK inhibitors combination with corticosteroids in BP treatment. In this retrospective study, the investigators conducted a comparative analysis to evaluate the efficacy and safety of JAK inhibitors combination With corticosteroids for patients diagnosed with moderate-to-severe bullous pemphigoid.
Read the detailed description
This study will conduct a retrospective review of patients with Bullous pemphigoid in the Department of Dermatology of the First Affiliated Hospital of Fujian Medical University. Researchers will initially screen patients based on the inclusion and exclusion criteria through their respective hospital's medical record systems at the beginning of the study. All enrolled patients will be followed for a duration of 48 weeks. This study will include approximately 300 patients with moderate to severe BP.
The Primary outcomes were the time to cease of new lesions, time to achieve minimal therapy, the cumulative amount of corticosteroids (at the time of achieving minimal therapy). The Secondary outcomes were the scores of BPDAI (week 0, week 2, and week 4). the scores of itching Numeric Rating Scale (NRS) (week 0, week 2, and week 4). the level of IgE (week 0, week 2) and eosinophil percentage (Eos%) (week 0, week 2). the clinical remissions at week 24 and week 48. Adverse events: all treatment-related adverse events (AEs) were assessed.
The statistical analysis was performed using GraphPad Prism software 10.0 and SPSS 29.0. Categorical variables were presented as frequencies and percentages. Continuous variables were represented as means and standard deviations (SD) or as medians and interquartile ranges (IQR). Absolute and relative frequencies were used to describe qualitative variables. Groups were compared using chi-square test for qualitative variables and independent sample t-test or analysis of variance (ANOVA) for quantitative variables with symmetric distribution. The Mann-Whitney U test or Kruskal-Wallis test were used for quantitative variables with skewed distributions. P< 0.05 was considered statistically significant.
Upon completion, the study will analyze the collected data and to assess the efficacy and safety of the combination of Janus kinase inhibitors and corticosteroids in treatment of BP.
- Conditions
- Bullous Pemphigoid, Janus Kinase Inhibitor, Corticosteroids
- Being tested
- Janus Kinase Inhibitor
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Janus Kinase InhibitorDrug
Janus Kinase Inhibitor in combination with corticosteroids
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to cease of new lesions
The time from baseline to cease of new blister formation.
Measured: 2022.01.01-2024.07.31
Time to achieve minimal therapy.
Minimal therapy defined as ≤ 0.1 mg/kg/d of prednisone (or equivalent) or 20 g/wk of clobetasol propionate and/or minimal adjuvant or maintenance therapy
Measured: 2022.01.01-2024.07.31
The cumulative amount of methylprednisolone (at the time of achieving minimal therapy).
The cumulative amount of methylprednisolone from baseline to the time of achieving minimal therapy
Measured: 2022.01.01-2024.07.31
Secondary outcomes (4)
The scores of BPDAI
the Bullous Pemphigoid Disease Area Index (BPDAI) scores and was classified into mild (BPDAI ≤ 19), moderate (20 ≤ BPDAI ≤ 56), and severe (BPDAI ≥ 57). This study included patients with moderate to severe BP.
Measured: 2022.01.01-2024.07.31
The scores of itching Numeric Rating Scale (NRS)
The patient is asked to rate their current level of itching on this 0-10 scale. 0 - No itching 1-3 - Mild itching 4-6 - Moderate itching 7-10 - Severe itching. This NRS score for itching can help healthcare providers assess the severity of the patient's itching, track changes over time, and guide appropriate treatment interventions.
Measured: 2022.01.01-2024.07.31
Adverse events
All treatment-related adverse events (AEs) were assessed.
Measured: 2022.01.01-2024.07.31
Clinical remissions
Partial remission on minimal therapy: presence of transient new lesions that heal within 1 week while patient is receiving minimal therapy for at least 2 months Complete remission on minimal therapy: absence of new or established lesions or pruritus while patient is receiving minimal therapy for at least 2 months Partial remission off therapy: presence of transient new lesions that heal within 1 week without treatment while patient is off all BP therapy for at least 2 months.
Complete remission off therapy: absence of new or established lesions or pruritus while patient is off all BP therapy for at least 2 months.
Measured: 2022.01.01-2024.07.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Jan 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chao Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chao Ji, First Affiliated Hospital of Fujian Medical University
- Investigators
- Chao Ji, PhD, Study chair, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561256
- Sponsor's protocol ID
- FirstAHFujian123
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Combination Therapy With Corticosteroids and JAK Inhibitors in Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT06561256
- Acronym / sponsor ID
- FirstAHFujian123
- Conditions
- Bullous Pemphigoid, Janus Kinase Inhibitor, Corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chao JiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 20 Aug 2024 (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.
Bullous pemphigoid (BP) is an autoimmune subepidermal blistering skin disease that predominantly affects the elderly population, with rare cases reported in children and adolescents. BP is characterized by circulating antibodies that target the hemidesmosomal proteins bullous pemphigoid Antigen 1 (BPAg1 or BP230) and bullous pemphigoid Antigen 2 (BPAg2 or BP180/collagen XVII) located at the dermal-epidermal junction. The first-line treatment of BP includes topical or systemic use of corticosteroids. For refractory cases or when corticosteroids are contraindicated or to minimize adverse effects, adjunct therapies such as immunosuppressants (e.g. azathioprine, cyclosporine), dapsone, tetracycline antibiotics combined with niacinamide, intravenous immunoglobulins (IVIG), and plasma exchange are employed. Recent research has explored the use of biologic agents to treat refractory BP, including anti-CD20 monoclonal antibodies, anti-IgE monoclonal antibodies, and anti-interleukin monoclonal antibodies, showing promising outcomes. Nevertheless, effectively managing BP remains a challenge.
The Janus kinase (JAK)-signal transducer and activator of transcription (STAT) pathway has been implicated as a key driver in many inflammatory diseases. Recently, a class of drugs targeting this pathway, known as JAK inhibitors, has been developed. Some studies have investigated the efficacy and safety of JAK inhibitors combination with corticosteroids in BP treatment. In this retrospective study, the investigators conducted a comparative analysis to evaluate the efficacy and safety of JAK inhibitors combination With corticosteroids for patients diagnosed with moderate-to-severe bullous pemphigoid.
Detailed description
This study will conduct a retrospective review of patients with Bullous pemphigoid in the Department of Dermatology of the First Affiliated Hospital of Fujian Medical University. Researchers will initially screen patients based on the inclusion and exclusion criteria through their respective hospital's medical record systems at the beginning of the study. All enrolled patients will be followed for a duration of 48 weeks. This study will include approximately 300 patients with moderate to severe BP.
The Primary outcomes were the time to cease of new lesions, time to achieve minimal therapy, the cumulative amount of corticosteroids (at the time of achieving minimal therapy). The Secondary outcomes were the scores of BPDAI (week 0, week 2, and week 4). the scores of itching Numeric Rating Scale (NRS) (week 0, week 2, and week 4). the level of IgE (week 0, week 2) and eosinophil percentage (Eos%) (week 0, week 2). the clinical remissions at week 24 and week 48. Adverse events: all treatment-related adverse events (AEs) were assessed.
The statistical analysis was performed using GraphPad Prism software 10.0 and SPSS 29.0. Categorical variables were presented as frequencies and percentages. Continuous variables were represented as means and standard deviations (SD) or as medians and interquartile ranges (IQR). Absolute and relative frequencies were used to describe qualitative variables. Groups were compared using chi-square test for qualitative variables and independent sample t-test or analysis of variance (ANOVA) for quantitative variables with symmetric distribution. The Mann-Whitney U test or Kruskal-Wallis test were used for quantitative variables with skewed distributions. P< 0.05 was considered statistically significant.
Upon completion, the study will analyze the collected data and to assess the efficacy and safety of the combination of Janus kinase inhibitors and corticosteroids in treatment of BP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All enrolled patients will be followed for a duration of 48 weeks. This study will include approximately 300 patients with moderate to severe BP. The Primary outcomes were the time to cease of new lesions, time to achieve minimal therapy, the cumulative amount of corticosteroids (at the time of achieving minimal therapy). The Secondary outcomes were the scores of BPDAI (week 0, week 2, and week 4). the scores of itching Numeric Rating Scale (NRS) (week 0, week 2, and week 4). the level of IgE (week 0, week 2) and eosinophil percentage (Eos%) (week 0, week 2). the clinical remissions at week 24 and week 48. Adverse events: all treatment-related adverse events (AEs) were assessed.
Key inclusion criteria (3 listed)
- Diagnosis of Bullous pemphigoid;
- Moderate to severe bullous pemphigoid； The disease severity was measured using the Bullous Pemphigoid Disease Area Index (BPDAI) score and was classified into mild (BPDAI ≤ 19), moderate (20 ≤ BPDAI ≤ 56), and severe (BPDAI ≥ 57).
- Moderate to severe BP received JAK Inhibitors combination with corticosteroids therapy；
Key exclusion criteria (2 listed)
- Patients diagnosed with malignant neoplasms
- Previous administration with biologics within 3 months
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 |
|---|---|---|
| Janus Kinase InhibitorJanus Kinase Inhibitor in combination with corticosteroids | Drug | – |
Primary outcome
Time to cease of new lesions
Time frame: 2022.01.01-2024.07.31
The time from baseline to cease of new blister formation.
Time to achieve minimal therapy.
Time frame: 2022.01.01-2024.07.31
Minimal therapy defined as ≤ 0.1 mg/kg/d of prednisone (or equivalent) or 20 g/wk of clobetasol propionate and/or minimal adjuvant or maintenance therapy
The cumulative amount of methylprednisolone (at the time of achieving minimal therapy).
Time frame: 2022.01.01-2024.07.31
The cumulative amount of methylprednisolone from baseline to the time of achieving minimal therapy
4 secondary outcomes
The scores of BPDAI
Time frame: 2022.01.01-2024.07.31
The scores of itching Numeric Rating Scale (NRS)
Time frame: 2022.01.01-2024.07.31
Adverse events
Time frame: 2022.01.01-2024.07.31
Clinical remissions
Time frame: 2022.01.01-2024.07.31
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 5 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Chao Ji, PhD study chair
First Affiliated Hospital of Fujian Medical University
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 and Janus Kinase Inhibitor, run by Chao Ji 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 2 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 5 Sep 2024. 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?
Time to cease of new lesions (time frame: 2022.01.01-2024.07.31). The study lists 3 primary outcomes in all. 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 5 Sep 2024.