Generalized Pustular PsoriasisNCT06391996
Biologic Therapy for Generalized Pustular Psoriasis
An observational study of Generalized Pustular Psoriasis, run by Chao Ji at 1 site in China.
Trial summary
The investigators aim to compare the efficacy and safety of secukinumab and ustekinumab in patients with generalized pustular psoriasis (GPP), and to explore the impact of genetic mutation types on clinical efficacy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Generalized Pustular Psoriasis
- What is being tested?
- After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.
- Type of treatment
- Injection or infusion
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a retrospective study of adult and pediatric patients with GPP. The investigators obtained data for 65 patients (33 children, 32 adults) who were admitted to the Department of Dermatology in the First Affiliated Hospital of Fujian Medical University because of GPP between July 2019 and Dec 2022. All patients were followed for 48 weeks.
Who may be able to join
- Patients meet the diagnostic criteria for GPP.
- Patients had an average GPPGA score of 3 or higher (moderate to severe disease).
- Patients had discontinued the treatment with non-biologic agents before they started the treatment with ustekinumab/secukinumab.
Who cannot join
- Pregnant and lactating patients.
- Patients with malignant tumors.
- Patients with a history of multiple drug allergies or a severe allergic constitution.
- Contraindications for ustekinumab/secukinumab, including active tuberculosis, active hepatitis B, hepatitis C, or inflammatory bowel disease.
- Patients who were severely immunocompromised.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350000
About this study
Official title: Genetics-based Efficacy Analysis: Ustekinumab Versus Secukinumab for the Treatment of Generalized Pustular Psoriasis
The investigators aim to compare the efficacy and safety of secukinumab and ustekinumab in patients with generalized pustular psoriasis (GPP), and to explore the impact of genetic mutation types on clinical efficacy. The main questions the study aims to answer are:
Is there a difference in the effectiveness of secukinumab and ustekinumab in the treatment of GPP? How is the safety of secukinumab and ustekinumab in the treatment of GPP? Does the type of genetic mutation in GPP patients affect the efficacy of secukinumab and ustekinumab? The investigators will compare patients treated with secukinumab to those treated with ustekinumab to see the difference in the effectiveness of the two drugs in treating GPP.
Read more
Participants will:
The investigators conducted a 48-week follow-up study on 65 participants who were admitted to the dermatology department of the First Affiliated Hospital of Fujian Medical University for GPP from July 2019 to December 2022. All participants underwent saliva-based genetic testing.
Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Area and Severity Index (GPPASI) and Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) at week 0, 2, 4, 12, 24, and 48.
Participants were also asked to report all adverse events (AEs) during follow-up.
- Conditions
- Generalized Pustular Psoriasis
- Being tested
- After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.
- Keywords
- Secukinumab, Ustekinumab, Clinical efficacy, Generalized pustular psoriasis, Safety, Gene mutations
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.Drug
Also called The investigators collected participants' saliva for genotyping.
During the treatment period, participants received either ustekinumab at weeks 0, 4, 16, and every 12 weeks thereafter until week 48, or secukinumab at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 48. The dose of ustekinumab/secukinumab was referenced to the dose used for moderate to severe plaque psoriasis. The single dose of ustekinumab was 45 mg for adult subjects weighing ≤ 100 kg, and 90 mg for subjects weighing > 100 kg. The ustekinumab dosage for pediatric participants was 0.75 mg/kg for participants weighing < 60 kg; 45 mg for pediatric participants weighing 60 kg to 100 kg; and 90 mg for pediatric participants weighing > 100 kg. The secukinumab dosage was 300mg for adult humans. Pediatric participants received a dose based on their weight category ( <50 kg, ≥50 kg): participants weighing < 50 kg received 75 mg, those weighing ≥ 50 kg received 150 mg.
| Study group | Role | What they receive |
|---|---|---|
| the ustekinumab group | Before treatment, participants underwent routine blood and urine tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver and kidney function tests, tuberculous infection of T cells spot tests, hepatitis B virus marker tests, chest CT scans, etc. After exclusion of relevant contraindications, participants received subcutaneous ustekinumab therapy. During the treatment period, participants received ustekinumab at weeks 0, 4, 16, and every 12 weeks thereafter until week 48. The single dose of ustekinumab was 45 mg for adult subjects weighing ≤ 100 kg, and 90 mg for subjects weighing > 100 kg. The ustekinumab dosage for pediatric participants was 0.75 mg/kg for participants weighing < 60 kg; 45 mg for pediatric participants weighing 60 kg to 100 kg; and 90 mg for pediatric participants weighing > 100 kg. Receives: Drug: After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy. | |
| the secukinumab group | Before treatment, participants underwent routine blood and urine tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver and kidney function tests, tuberculous infection of T cells spot tests, hepatitis B virus marker tests, chest CT scans, etc. After exclusion of relevant contraindications, participants received subcutaneous secukinumab therapy. During the treatment period, participants received secukinumab at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 48. The secukinumab dosage was 300mg for adult humans. Pediatric participants received a dose based on their weight category (< 50 kg, ≥ 50 kg): participants weighing < 50 kg received 75 mg, those weighing ≥ 50 kg received 150 mg. Receives: Drug: After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPASI.
Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Area and Severity Index (GPPASI) at week 0, 2, 4, 12, 24, and 48. GPPASI provided a numeric scoring system to assess patient's overall disease state of GPP, ranging from 0 to 72, with higher scores indicating more severe conditions. Clinical efficacy was evaluated by GPPASI -50, -75, -90, and -100 responses at each time point.
Measured: 48 weeks
Secondary outcomes (3)
To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPGA.
Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) at week 0, 2, 4, 12, 24, and 48. The investigator scored the erythema, pustules, and scale of all GPP lesions from 0 to 4 using GPPGA. Each component was graded separately, and the average was calculated. The final GPPGA was determined by this composite score.
Measured: 48 weeks
By saliva-based genetic testing, analyze the mutation rates of common mutation gene sites in GPP.
To analyze whether gene mutations cause different responses to ustekinumab and secukinumab in GPP patients.
Measured: 48 weeks
Analyzing the incidence of adverse reactions to ustekinumab and secukinumab in the treatment of GPP.
During the follow-up period, participants are requested to report all adverse reactions experienced since their last visit, such as rash, diarrhea, infections, etc., and record the type, onset time, severity, duration, triggering, and relieving factors of the adverse reactions.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jul 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Pustular PsoriasisStudies 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
- 65 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391996
- Sponsor's protocol ID
- MRCTA,ECFAH of FMU [2022]007
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics-based Efficacy Analysis: Ustekinumab Versus Secukinumab for the Treatment of Generalized Pustular Psoriasis
- ClinicalTrials.gov ID
- NCT06391996
- Acronym / sponsor ID
- MRCTA,ECFAH of FMU [2022]007
- Conditions
- Generalized Pustular Psoriasis
- Keywords
- Secukinumab, Ustekinumab, Clinical efficacy, Generalized pustular psoriasis, Safety, Gene mutations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Chao JiUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 30 Apr 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.
The investigators aim to compare the efficacy and safety of secukinumab and ustekinumab in patients with generalized pustular psoriasis (GPP), and to explore the impact of genetic mutation types on clinical efficacy. The main questions the study aims to answer are:
Is there a difference in the effectiveness of secukinumab and ustekinumab in the treatment of GPP? How is the safety of secukinumab and ustekinumab in the treatment of GPP? Does the type of genetic mutation in GPP patients affect the efficacy of secukinumab and ustekinumab? The investigators will compare patients treated with secukinumab to those treated with ustekinumab to see the difference in the effectiveness of the two drugs in treating GPP.
Participants will:
The investigators conducted a 48-week follow-up study on 65 participants who were admitted to the dermatology department of the First Affiliated Hospital of Fujian Medical University for GPP from July 2019 to December 2022. All participants underwent saliva-based genetic testing.
Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Area and Severity Index (GPPASI) and Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) at week 0, 2, 4, 12, 24, and 48.
Participants were also asked to report all adverse events (AEs) during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the ustekinumab group | – | Drug: After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.Before treatment, participants underwent routine blood and urine tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver and kidney function tests, tuberculous infection of T cells spot tests, hepatitis B virus marker tests, chest CT scans, etc. After exclusion of relevant contraindications, participants received subcutaneous ustekinumab therapy. During the treatment period, participants received ustekinumab at weeks 0, 4, 16, and every 12 weeks thereafter until week 48. The single dose of ustekinumab was 45 mg for adult subjects weighing ≤ 100 kg, and 90 mg for subjects weighing > 100 kg. The ustekinumab dosage for pediatric participants was 0.75 mg/kg for participants weighing < 60 kg; 45 mg for pediatric participants weighing 60 kg to 100 kg; and 90 mg for pediatric participants weighing > 100 kg. |
| the secukinumab group | – | Drug: After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.Before treatment, participants underwent routine blood and urine tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver and kidney function tests, tuberculous infection of T cells spot tests, hepatitis B virus marker tests, chest CT scans, etc. After exclusion of relevant contraindications, participants received subcutaneous secukinumab therapy. During the treatment period, participants received secukinumab at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 48. The secukinumab dosage was 300mg for adult humans. Pediatric participants received a dose based on their weight category (< 50 kg, ≥ 50 kg): participants weighing < 50 kg received 75 mg, those weighing ≥ 50 kg received 150 mg. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a retrospective study of adult and pediatric patients with GPP. The investigators obtained data for 65 patients (33 children, 32 adults) who were admitted to the Department of Dermatology in the First Affiliated Hospital of Fujian Medical University because of GPP between July 2019 and Dec 2022. All patients were followed for 48 weeks.
Key inclusion criteria (3 listed)
- Patients meet the diagnostic criteria for GPP.
- Patients had an average GPPGA score of 3 or higher (moderate to severe disease).
- Patients had discontinued the treatment with non-biologic agents before they started the treatment with ustekinumab/secukinumab.
Key exclusion criteria (5 listed)
- Pregnant and lactating patients.
- Patients with malignant tumors.
- Patients with a history of multiple drug allergies or a severe allergic constitution.
- Contraindications for ustekinumab/secukinumab, including active tuberculosis, active hepatitis B, hepatitis C, or inflammatory bowel disease.
- Patients who were severely immunocompromised.
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 |
|---|---|---|
| After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.Also: The investigators collected participants' saliva for genotyping.During the treatment period, participants received either ustekinumab at weeks 0, 4, 16, and every 12 weeks thereafter until week 48, or secukinumab at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 48. The dose of ustekinumab/secukinumab was referenced to the dose used for moderate to severe plaque psoriasis. The single dose of ustekinumab was 45 mg for adult subjects weighing ≤ 100 kg, and 90 mg for subjects weighing > 100 kg. The ustekinumab dosage for pediatric participants was 0.75 mg/kg for participants weighing < 60 kg; 45 mg for pediatric participants weighing 60 kg to 100 kg; and 90 mg for pediatric participants weighing > 100 kg. The secukinumab dosage was 300mg for adult humans. Pediatric participants received a dose based on their weight category ( <50 kg, ≥50 kg): participants weighing < 50 kg received 75 mg, those weighing ≥ 50 kg received 150 mg. | Drug | the secukinumab group, the ustekinumab group |
Primary outcome
To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPASI.
Time frame: 48 weeks
Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Area and Severity Index (GPPASI) at week 0, 2, 4, 12, 24, and 48. GPPASI provided a numeric scoring system to assess patient's overall disease state of GPP, ranging from 0 to 72, with higher scores indicating more severe conditions. Clinical efficacy was evaluated by GPPASI -50, -75, -90, and -100 responses at each time point.
3 secondary outcomes
To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPGA.
Time frame: 48 weeks
By saliva-based genetic testing, analyze the mutation rates of common mutation gene sites in GPP.
Time frame: 48 weeks
Analyzing the incidence of adverse reactions to ustekinumab and secukinumab in the treatment of GPP.
Time frame: 48 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 30 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Generalized Pustular Psoriasis, 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 5 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 30 Apr 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?
To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPASI. (time frame: 48 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 30 Apr 2024.