Erythrodermic PsoriasisNCT06801028
Efficacy of Injection Sekucinumab in Erythrodermic Psoriasis
An observational study of Erythrodermic Psoriasis, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
Erythroderma is a rare and severe dermatological manifestation of a variety of diseases. The most common form of erythroderma is erythrodermic psoriasis (EP), which accounts for 1-2.25% of all psoriatic patients, with a male predominance as demonstrated by a male to female ratio of 3:1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erythrodermic Psoriasis
- What is being tested?
- injection Sekucinumab
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jan 2025to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: EP Patients presenting with the histological and/or clinical manifestations (Erythrodermic Psoriasis such as redness, inflammation, skin rash, erythema, scaling, and itch) on more than 90% of body surface area.
Who may be able to join
- Patients of age 18-65 years age.
- Either sex.
- Patients presenting with the clinical manifestations of Erythrodermic Psoriasis such as redness, inflammation, skin rash, erythema, scaling, and itch on more than 90% of body surface area.
Who cannot join
- Patients of pediatric age.
- Erythroderma caused by a condition other than psoriasis.
- Patient treated with biologics for a different condition other than EP.
- Diabetic, immunocompromised patients.
- Women with pregnancy or lactating mothers.
- Patients allergic to the drugs in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Department of Dermatology Jinnah Postgraduate Medical Center (JPMC), Karachi
Karachi, Sindh, 22557
Maria Iqbal, MBBS, FCPS Trainee, +923001057555, mariashaikh140@gmail.com
About this study
Erythroderma is a rare and severe dermatological manifestation of a variety of diseases. The most common form of erythroderma is erythrodermic psoriasis (EP), which accounts for 1-2.25% of all psoriatic patients, with a male predominance as demonstrated by a male to female ratio of 3:1. EP clinically manifests with diffuse erythema involving also skin folds with or without exfoliate dermatitis. Secukinumab is a FDA approved biological targeting interleukin-17A (IL17A) cytokine used in the treatment of moderate-to-severe psoriasis. Many clinical trials have been undertaken to establish its efficacy and safety in psoriasis. Numerous studies have highlighted the efficacy and safety of secukinumab. Secukinumab yields rapid and sustained improvements of signs and symptoms in patients EP. Secukinumab also had the lowest treatment cost compared with other biologic treatments for moderate to severe psoriasis. Secukinumab is a monoclonal antibody targeting IL-17, a key player in psoriasis pathogenesis, making it highly effective for psoriasis management. Erythrodermic psoriasis (EP) is a rare, severe form of the disease, affecting over 90% of the body, with significant health risks like electrolyte imbalance and infection. Treatment options for EP are not standardized due to its rarity, and conventional therapies such as acitretin, ciclosporin, and methotrexate have limited efficacy and tolerance issues. While biologics are well-studied for plaque psoriasis, data on EP is scarce. This study aims to evaluate secukinumab's efficacy in EP and explore factors influencing treatment outcomes.
Read the detailed description
This observational descriptive longitudinal study will be conducted at OPD patients in the Department of Dermatology, Jinnah Postgraduate Medical Center. after taking ethical approval from institutional ethical review board. Informed consent will be obtained from all the patients. Erythrodermic Psoriasis patients aged 18 years and older, who received the complete treatment course of secukinumab will be included. Before secukinumab treatment, all infections including hepatitis B and C virus infection and tuberculosis (Tb) status are evaluated by history, physical examination, complete blood count, C reactive protein, transaminases, complete urinalysis, chest X-Ray studies, Purified Protein Derivative (PPD) test and/or QuantiFERON-TB tests and hepatitis B, C viruses markers, etc.
All patients with erythrodermic psoriasis (EP), who will receive subcutaneous injection of secukinumab at a dose of 300 mg once a week from week 0 to 4 followed by every 4 week. At weeks 0, 4, 8, 12, 16 and 20 the psoriasis area and severity index (PASI) will be recorded and adverse drug reactions, patient's satisfaction and recurrence will be observed.
Demographics and clinical features will be recorded, including: age; gender; previous Psoriasis Area Severity Index (PASI) score before erythroderma, if any; previous anti-psoriatic therapy; biologic therapy exposure; secukinumab response; side effects; drug use history; PASI and patients satisfaction at weeks 4, 8, 12, 16, and 20. Efficacy assessment will be performed by measuring change in PASI score from baseline. PASI-75 will be considered as efficacy of treatment. It will be assessed after treatment induction (Week 4) at 4, 8, 12, 16 and 20 week. Adverse effects, recurrence and reasons for discontinuation secukinumab will be recorded.
- Conditions
- Erythrodermic Psoriasis
- Being tested
- injection Sekucinumab
- Keywords
- Erythrodermic Psoriasis, Efficacy, Sekucinumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection SekucinumabBiological
All patients with erythrodermic psoriasis (EP), who will receive subcutaneous injection of secukinumab at a dose of 300 mg once a week from week 0 to 4 followed by every 4 week. At weeks 0, 4, 8, 12, 16 and 20 the psoriasis area and severity index (PASI) will be recorded and adverse drug reactions, patient's satisfaction and recurrence will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Erythrodermic Psoriasis | Erythrodermic Psoriasis will be treated by injection Sekucinumab Receives: Biological: injection Sekucinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (Psoriasis Area Severity Index (PASI) Score)
The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis.
It combines the severity (erythema, induration and desquamation) and percentage of affected area. The Psoriasis Area Severity Index (PASI) Calculator (1.7.3) (https://pasi.corti.li/ ) or manual working sheet https://www.huidziekten.nl/pdf/PASI-Psoriasis-Area-and-Severity-Index.pdf.) will be utilized to calculate the PASI score at each time interval.
Efficacy assessment will be performed by measuring change in PASI score from baseline. PASI-75 (75% or greater improvement/ 75% or more reduction in PASI score) will be considered as efficacy of treatment. It will be assessed after treatment induction (Week 4) at 4, 8, 12, 16 and 20 week.
Measured: 20th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythrodermic 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Iqbal, Jinnah Postgraduate Medical Centre
- Investigators
- Maria Iqbal, MBBS, FCPS Trainee, Principal investigator, JPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801028
- Sponsor's protocol ID
- NO.F.2-81/2024-GENL/137/JPMC
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 30 Jan 2025
- 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 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Injection Sekucinumab in Erythrodermic Psoriasis
- ClinicalTrials.gov ID
- NCT06801028
- Acronym / sponsor ID
- NO.F.2-81/2024-GENL/137/JPMC
- Conditions
- Erythrodermic Psoriasis
- Keywords
- Erythrodermic Psoriasis, Efficacy, Sekucinumab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 30 Jan 2025 (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.
Erythroderma is a rare and severe dermatological manifestation of a variety of diseases. The most common form of erythroderma is erythrodermic psoriasis (EP), which accounts for 1-2.25% of all psoriatic patients, with a male predominance as demonstrated by a male to female ratio of 3:1. EP clinically manifests with diffuse erythema involving also skin folds with or without exfoliate dermatitis. Secukinumab is a FDA approved biological targeting interleukin-17A (IL17A) cytokine used in the treatment of moderate-to-severe psoriasis. Many clinical trials have been undertaken to establish its efficacy and safety in psoriasis. Numerous studies have highlighted the efficacy and safety of secukinumab. Secukinumab yields rapid and sustained improvements of signs and symptoms in patients EP. Secukinumab also had the lowest treatment cost compared with other biologic treatments for moderate to severe psoriasis. Secukinumab is a monoclonal antibody targeting IL-17, a key player in psoriasis pathogenesis, making it highly effective for psoriasis management. Erythrodermic psoriasis (EP) is a rare, severe form of the disease, affecting over 90% of the body, with significant health risks like electrolyte imbalance and infection. Treatment options for EP are not standardized due to its rarity, and conventional therapies such as acitretin, ciclosporin, and methotrexate have limited efficacy and tolerance issues. While biologics are well-studied for plaque psoriasis, data on EP is scarce. This study aims to evaluate secukinumab's efficacy in EP and explore factors influencing treatment outcomes.
Detailed description
This observational descriptive longitudinal study will be conducted at OPD patients in the Department of Dermatology, Jinnah Postgraduate Medical Center. after taking ethical approval from institutional ethical review board. Informed consent will be obtained from all the patients. Erythrodermic Psoriasis patients aged 18 years and older, who received the complete treatment course of secukinumab will be included. Before secukinumab treatment, all infections including hepatitis B and C virus infection and tuberculosis (Tb) status are evaluated by history, physical examination, complete blood count, C reactive protein, transaminases, complete urinalysis, chest X-Ray studies, Purified Protein Derivative (PPD) test and/or QuantiFERON-TB tests and hepatitis B, C viruses markers, etc.
All patients with erythrodermic psoriasis (EP), who will receive subcutaneous injection of secukinumab at a dose of 300 mg once a week from week 0 to 4 followed by every 4 week. At weeks 0, 4, 8, 12, 16 and 20 the psoriasis area and severity index (PASI) will be recorded and adverse drug reactions, patient's satisfaction and recurrence will be observed.
Demographics and clinical features will be recorded, including: age; gender; previous Psoriasis Area Severity Index (PASI) score before erythroderma, if any; previous anti-psoriatic therapy; biologic therapy exposure; secukinumab response; side effects; drug use history; PASI and patients satisfaction at weeks 4, 8, 12, 16, and 20. Efficacy assessment will be performed by measuring change in PASI score from baseline. PASI-75 will be considered as efficacy of treatment. It will be assessed after treatment induction (Week 4) at 4, 8, 12, 16 and 20 week. Adverse effects, recurrence and reasons for discontinuation secukinumab will be recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erythrodermic Psoriasis | – | Biological: injection SekucinumabErythrodermic Psoriasis will be treated by injection Sekucinumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- EP Patients presenting with the histological and/or clinical manifestations (Erythrodermic Psoriasis such as redness, inflammation, skin rash, erythema, scaling, and itch) on more than 90% of body surface area.
Key inclusion criteria (3 listed)
- Patients of age 18-65 years age.
- Either sex.
- Patients presenting with the clinical manifestations of Erythrodermic Psoriasis such as redness, inflammation, skin rash, erythema, scaling, and itch on more than 90% of body surface area.
Key exclusion criteria (6 listed)
- Patients of pediatric age.
- Erythroderma caused by a condition other than psoriasis.
- Patient treated with biologics for a different condition other than EP.
- Diabetic, immunocompromised patients.
- Women with pregnancy or lactating mothers.
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 |
|---|---|---|
| injection SekucinumabAll patients with erythrodermic psoriasis (EP), who will receive subcutaneous injection of secukinumab at a dose of 300 mg once a week from week 0 to 4 followed by every 4 week. At weeks 0, 4, 8, 12, 16 and 20 the psoriasis area and severity index (PASI) will be recorded and adverse drug reactions, patient's satisfaction and recurrence will be observed. | Biological | Erythrodermic Psoriasis |
Primary outcome
Efficacy (Psoriasis Area Severity Index (PASI) Score)
Time frame: 20th week
The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. The Psoriasis Area Severity Index (PASI) Calculator (1.7.3) (https://pasi.corti.li/ ) or manual working sheet https://www.huidziekten.nl/pdf/PASI-Psoriasis-Area-and-Severity-Index.pdf.) will be utilized to calculate the PASI score at each time interval. Efficacy assessment will be performed by measuring change in PASI score from baseline. PASI-75 (75% or greater improvement/ 75% or more reduction in PASI score) will be considered as efficacy of treatment. It will be assessed after treatment induction (Week 4) at 4, 8, 12, 16 and 20 week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Erythrodermic Psoriasis
Active, not recruitingObservational study
A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis
Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Generalized Pustular Psoriasis, Erythrodermic Psoriasis
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.
Maria Iqbal, MBBS, FCPS Trainee principal investigator
JPMC
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 Erythrodermic Psoriasis, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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 6 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: opening soon, as of the sponsor's last update on 30 Jan 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Iqbal, MBBS, FCPS Trainee (00923001057555, mariashaikh140@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (Psoriasis Area Severity Index (PASI) Score) (time frame: 20th week). 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 Jan 2025.