Psoriasis VulgarisNCT03828643
Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis
An observational study of Psoriasis Vulgaris, run by Universita di Verona at 1 site in Italy.
Trial summary
This was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Secukinumab
- How many people
- 156 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2019to 12 Apr 2019
- 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: Patients with moderate to severe chronic plaque psoriasis attended two Dermatological centers of North Italy in Veneto (Azienda Ospedaliera Universitaria of Verona and Azienda Ospedaliera of Padua) dedicated to the care of patients with psoriasis
Who may be able to join
- Patients older than 18 years old
- Patients with moderate to severe chronic plaque psoriasis treated with secukinumab with or without initial loading dose for at least 48 week
- The criteria for receiving secukinumab were according to standard clinical practice.
Who cannot join
- Patients younger than 18 years old
- Patients with only psoriatic arthritis or with other forms of psoriasis than chronic plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis)
- Pregnant women and women during breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis
This was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and controls. Safety was evaluated by reporting every adverse events up to week 48.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Secukinumab
- Keywords
- Secukinumab, loading dose, chronic plaque psoriasis, no loading dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.
SecukinumabDrug
Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning. Receives: Drug: Secukinumab | |
| Controls | Controls received secukinumab at the dose 300 mg with loading dose at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI75
Measured: week 48
Secondary outcomes (1)
PASI90
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start20 Mar 2019
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Gisondi, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828643
- Sponsor's protocol ID
- Gisondi 3
- Status last verified
- Apr 2019
- First submitted
- 31 Jan 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03828643
- Acronym / sponsor ID
- Gisondi 3
- Conditions
- Psoriasis Vulgaris
- Keywords
- Secukinumab, loading dose, chronic plaque psoriasis, no loading dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 4 Feb 2019 (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 was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and controls. Safety was evaluated by reporting every adverse events up to week 48.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Drug: SecukinumabCases received secukinumab at the dose 300 mg every 4 weeks from the beginning. |
| Controls | – | Drug: SecukinumabControls received secukinumab at the dose 300 mg with loading dose at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe chronic plaque psoriasis attended two Dermatological centers of North Italy in Veneto (Azienda Ospedaliera Universitaria of Verona and Azienda Ospedaliera of Padua) dedicated to the care of patients with psoriasis
Key inclusion criteria (3 listed)
- Patients older than 18 years old
- Patients with moderate to severe chronic plaque psoriasis treated with secukinumab with or without initial loading dose for at least 48 week
- The criteria for receiving secukinumab were according to standard clinical practice.
Key exclusion criteria (3 listed)
- Patients younger than 18 years old
- Patients with only psoriatic arthritis or with other forms of psoriasis than chronic plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis)
- Pregnant women and women during breastfeeding
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 |
|---|---|---|
| SecukinumabSecukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4. | Drug | Cases |
| SecukinumabSecukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4. | Drug | Controls |
Primary outcome
PASI75
Time frame: week 48
1 secondary outcome
PASI90
Time frame: week 48
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 16 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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 Psoriasis Vulgaris, run by Universita di Verona at 1 site in Italy.
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 16 Apr 2019. 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 Italy. 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?
PASI75 (time frame: week 48). 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 16 Apr 2019.