Plaque PsoriasisPhase 4NCT05891964
Outcome of Treatment With Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis at Tertiary Care Hospital.
A Phase 4 study testing Secukinumab Injection in people with Plaque Psoriasis, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
Psoriasis is one of the most common immune-mediated inflammatory disorders characterized by a chronic course. It affects approximately 2-3% of the world's population Psoriasis may be provoked by environmental factors in patients with genetic predispositions. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Secukinumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jul 2021to 10 Jul 2022
- Phase
- Phase 4
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known plaque psoriasis
- Either gender
- Age 30-80 years.
Who cannot join
- Patients with history of eczema.
- Patients with history connective tissue disorder, vasculitis malignancy, seropositive or seronegative arthritis.
- Patients with history of malignancy.
- Patient with history of hepatis B, C or AIDS.
- Immunocompromised patients.
- Pregnant patients assessed by history and confirmed by dating scan.
- Patients with history of chronic liver disease, chronic kidney disease, asthma, acute coronary syndrome, congestive heart failure and chronic obstructive pulmonary disease will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Psoriasis is one of the most common immune-mediated inflammatory disorders characterized by a chronic course. It affects approximately 2-3% of the world's population Psoriasis may be provoked by environmental factors in patients with genetic predispositions. Psoriasis is phenotypically characterized by thickened, red, scaly plaques and systemic inflammation, it is also associated with multiple comorbidities, such as cardiovascular disease, stroke, hypertension, metabolic diseases, chronic kidney disease, and joint destruction. Psoriasis is pathogenically driven by proinflammatory cytokines and mediated by T and dendritic cells. Inflammatory myeloid dendritic cells release interleukin (IL) 23 and IL-12 to activate IL-17-producing T cells, Th1 cells, and Th22 cells to produce psoriatic cytokines like IL-17, interferon (IFN) γ, TNF, and IL-22. These cytokines mediate the effects on keratinocytes. Secukinumab is a recombinant human monoclonal antibody that specifically binds to a proinflammatory cytokine released by T-helper-17 (Th17) cells, IL-17A. It blocks its binding with IL-17R and the expression of cytokines. This blockade normalizes the inflammatory processes and combats epidermal hyperproliferation, T-cell infiltration, and exaggerated expression of pathogenic genes.
Read the detailed description
Plaque psoriasis is a chronic autoimmune skin disorder characterized by the formation of thick, scaly plaques on the skin surface. It affects millions of individuals worldwide and significantly impacts their quality of life. While several treatment options exist, a substantial number of patients with moderate to severe plaque psoriasis fail to achieve satisfactory results or experience intolerable side effects with conventional therapies.
Psoriasis is pathogenically driven by proinflammatory cytokines and mediated by T cells and dendritic cells. In recent years, the advent of biologic agents targeting specific immune pathways has revolutionized the management of psoriasis. Secukinumab, a fully human monoclonal antibody that selectively inhibits interleukin-17A, has shown promising results in randomized controlled trials and real-world studies. However, there remains a need to assess the real-world effectiveness and safety of Secukinumab in routine clinical practice, particularly in patients with moderate to severe plaque psoriasis who may have diverse characteristics and treatment histories.
This observational study aims to evaluate the real-world effectiveness and safety of Secukinumab in patients with moderate to severe plaque psoriasis. By collecting data from a diverse patient population in routine clinical settings, we aim to provide valuable insights into the outcomes and experiences of patients receiving Secukinumab outside the controlled environment of clinical trials.
- Conditions
- Plaque Psoriasis
- Being tested
- Secukinumab Injection
- Keywords
- Plaque Psoriasis, Secukinumab Injection, Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab InjectionDrug
Also called Cosentyx
Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months. Receives: Drug: Secukinumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Secukinumab in the treatment of moderate to severe plaque psoriasis
Efficacy will be assessed using psoriasis area and severity index. The minimum score of psoriasis area and severity index is 0 and the maximum score is 72. All patients who will be presented with 75% reduction in the Psoriasis Area and Severity Index at the end of the therapy compared to baseline will be labelled as positive for efficacy.
Measured: From day of randomisation until final dose of drug,assessed upto 12 months.
Secondary outcomes (1)
Mean difference of Psoriasis Area and Severity Index score before and after the treatment
Psoriasis area and severity index score difference before the treatment and after the treatment will be measured
Measured: From day of randomisation until final dose of drug,assessed upto 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start5 Jul 2021
- Primary completion5 Jun 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Faiza Inam Siddiqui, Jinnah Postgraduate Medical Centre
- Investigators
- Faiza I Siddiqui, Principal investigator, Jinnah post graduate Medical centreRabia Ghafoor, Principal investigator, Jinnah post graduate Medical centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891964
- Sponsor's protocol ID
- NO.F2-81/2022-GENL/252/JPMC
- Status last verified
- Jun 2023
- First submitted
- 22 Mar 2023
- Last updated
- 7 Jun 2023
- Results posted
- 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Treatment With Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis at Tertiary Care Hospital.
- ClinicalTrials.gov ID
- NCT05891964
- Acronym / sponsor ID
- NO.F2-81/2022-GENL/252/JPMC
- Conditions
- Plaque Psoriasis
- Keywords
- Plaque Psoriasis, Secukinumab Injection, Outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 7 Jun 2023 (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.
Psoriasis is one of the most common immune-mediated inflammatory disorders characterized by a chronic course. It affects approximately 2-3% of the world's population Psoriasis may be provoked by environmental factors in patients with genetic predispositions. Psoriasis is phenotypically characterized by thickened, red, scaly plaques and systemic inflammation, it is also associated with multiple comorbidities, such as cardiovascular disease, stroke, hypertension, metabolic diseases, chronic kidney disease, and joint destruction. Psoriasis is pathogenically driven by proinflammatory cytokines and mediated by T and dendritic cells. Inflammatory myeloid dendritic cells release interleukin (IL) 23 and IL-12 to activate IL-17-producing T cells, Th1 cells, and Th22 cells to produce psoriatic cytokines like IL-17, interferon (IFN) γ, TNF, and IL-22. These cytokines mediate the effects on keratinocytes. Secukinumab is a recombinant human monoclonal antibody that specifically binds to a proinflammatory cytokine released by T-helper-17 (Th17) cells, IL-17A. It blocks its binding with IL-17R and the expression of cytokines. This blockade normalizes the inflammatory processes and combats epidermal hyperproliferation, T-cell infiltration, and exaggerated expression of pathogenic genes.
Detailed description
Plaque psoriasis is a chronic autoimmune skin disorder characterized by the formation of thick, scaly plaques on the skin surface. It affects millions of individuals worldwide and significantly impacts their quality of life. While several treatment options exist, a substantial number of patients with moderate to severe plaque psoriasis fail to achieve satisfactory results or experience intolerable side effects with conventional therapies.
Psoriasis is pathogenically driven by proinflammatory cytokines and mediated by T cells and dendritic cells. In recent years, the advent of biologic agents targeting specific immune pathways has revolutionized the management of psoriasis. Secukinumab, a fully human monoclonal antibody that selectively inhibits interleukin-17A, has shown promising results in randomized controlled trials and real-world studies. However, there remains a need to assess the real-world effectiveness and safety of Secukinumab in routine clinical practice, particularly in patients with moderate to severe plaque psoriasis who may have diverse characteristics and treatment histories.
This observational study aims to evaluate the real-world effectiveness and safety of Secukinumab in patients with moderate to severe plaque psoriasis. By collecting data from a diverse patient population in routine clinical settings, we aim to provide valuable insights into the outcomes and experiences of patients receiving Secukinumab outside the controlled environment of clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Drug: Secukinumab InjectionInjection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Known plaque psoriasis
- Either gender
- Age 30-80 years.
Key exclusion criteria (7 listed)
- Patients with history of eczema.
- Patients with history connective tissue disorder, vasculitis malignancy, seropositive or seronegative arthritis.
- Patients with history of malignancy.
- Patient with history of hepatis B, C or AIDS.
- Immunocompromised patients.
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 |
|---|---|---|
| Secukinumab InjectionAlso: CosentyxInjection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months. | Drug | Secukinumab |
Primary outcome
Efficacy of Secukinumab in the treatment of moderate to severe plaque psoriasis
Time frame: From day of randomisation until final dose of drug,assessed upto 12 months.
Efficacy will be assessed using psoriasis area and severity index. The minimum score of psoriasis area and severity index is 0 and the maximum score is 72. All patients who will be presented with 75% reduction in the Psoriasis Area and Severity Index at the end of the therapy compared to baseline will be labelled as positive for efficacy.
1 secondary outcome
Mean difference of Psoriasis Area and Severity Index score before and after the treatment
Time frame: From day of randomisation until final dose of drug,assessed upto 12 months.
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 7 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque 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. This study is not recruiting at the moment.
Faiza I Siddiqui principal investigator
Jinnah post graduate Medical centre
Rabia Ghafoor principal investigator
Jinnah post graduate Medical centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Secukinumab Injection in people with Plaque 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 7 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 7 Jun 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy of Secukinumab in the treatment of moderate to severe plaque psoriasis (time frame: From day of randomisation until final dose of drug,assessed upto 12 months.). 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 7 Jun 2023.