PsoriasisPhase 4NCT02592018
Immunologic Response to Secukinumab in Plaque Psoriasis
A Phase 4 study testing Secukinumab in people with Psoriasis, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a single-arm, open-label study, which will examine the effect of secukinumab on the immunologic and genetic environment within psoriatic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Secukinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Dec 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Ability to provide written informed consent and comply with the protocol.
- At least 18 years of age.
- Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.
- Subject is considered a candidate for phototherapy or systemic therapy
- PASI ≥ 12
- PGA ≥ 3
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- Subject has a negative Quantiferon Gold, or if positive undergoes CXR. If CXR negative, subject initiated prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
- Subject is unlikely to conceive (male, post-menopausal, or using adequate oral contraceptive therapy or IUD).
- Physical exam within clinically acceptable limits.
Who cannot join
- Subject is unable to provide written informed consent or comply with the protocol.
- Subject is younger than 18 years of age.
- Subject has predominately non-plaque form of psoriasis.
- Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy or systemic treatments.
- Subject has drug-induced psoriasis.
- Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
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- Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).
- Screening total white blood cell (WBC count) < 2,500/μl, platelets < 100,000/μl, neutrophils < 1,500/μl, or hemoglobin <8.5 g/dl.
- Evidence of active tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) with a positive chest X-ray at screening, or untreated latent tuberculosis defined by positive QFT with a negative chest X-ray without prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
- History of an ongoing, chronic or recurrent infectious disease including past medical history record of HIV, hepatitis B or hepatitis C.
- Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere with the evaluation of the subject's psoriasis.
- History of known or suspected intolerance to any of the ingredients of the investigational study product.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118
About this study
Official title: Characterization of the Response to Secukinumab in Plaque Psoriasis Using Novel Immunologic and Genetic Profiling
This is a single-arm, open-label study, which will examine the effect of secukinumab on the immunologic and genetic environment within psoriatic lesions.
Read the detailed description
Quantitative analysis of the immunologic changes in immune cell populations will be performed after secukinumab treatment in 15 patients at weeks 2, 4, and 12 compared to baseline week 0. The immunologic profiles in psoriasis patients will also be compared to healthy control skin surgical discard specimens (n=10). The number of differentially expressed genes in each cell population will be quantified by RNA-seq at weeks 2, 4, 12 after secukinumab compared to baseline.
- Conditions
- Psoriasis
- Being tested
- Secukinumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
Also called Cosentyx
Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Measured: Baseline to Week 2
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Measured: Baseline to Week 4
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Measured: Baseline to Week 12
Secondary outcomes (9)
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants
by RNA-seq
Measured: Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
by RNA-seq
Measured: Baseline to Week 4
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
by RNA-seq
Measured: Baseline to Week 12
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
by RNA-seq
Measured: Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
by RNA-seq
Measured: Baseline to Week 4
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
by RNA-seq
Measured: Baseline to Week 12
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
by RNA-seq
Measured: Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
by RNA-seq
Measured: Baseline to Week 4
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
by RNA-seq
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Wilson Liao, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592018
- Sponsor's protocol ID
- CAIN457AUS04T
- Status last verified
- Aug 2020
- First submitted
- 16 Oct 2015
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Response to Secukinumab in Plaque Psoriasis Using Novel Immunologic and Genetic Profiling
- ClinicalTrials.gov ID
- NCT02592018
- Acronym / sponsor ID
- CAIN457AUS04T
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Posted 27 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, open-label study, which will examine the effect of secukinumab on the immunologic and genetic environment within psoriatic lesions.
Detailed description
Quantitative analysis of the immunologic changes in immune cell populations will be performed after secukinumab treatment in 15 patients at weeks 2, 4, and 12 compared to baseline week 0. The immunologic profiles in psoriasis patients will also be compared to healthy control skin surgical discard specimens (n=10). The number of differentially expressed genes in each cell population will be quantified by RNA-seq at weeks 2, 4, 12 after secukinumab compared to baseline.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Drug: SecukinumabAll subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to provide written informed consent and comply with the protocol.
- At least 18 years of age.
- Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.
- Subject is considered a candidate for phototherapy or systemic therapy
- PASI ≥ 12
Key exclusion criteria (12 listed)
- Subject is unable to provide written informed consent or comply with the protocol.
- Subject is younger than 18 years of age.
- Subject has predominately non-plaque form of psoriasis.
- Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy or systemic treatments.
- Subject has drug-induced psoriasis.
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 |
|---|---|---|
| SecukinumabAlso: CosentyxSecukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12. | Drug | Secukinumab |
Primary outcome
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Time frame: Baseline to Week 2
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Time frame: Baseline to Week 4
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Time frame: Baseline to Week 12
9 secondary outcomes
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants
Time frame: Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
Time frame: Baseline to Week 4
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
Time frame: Baseline to Week 12
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Time frame: Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Time frame: Baseline to Week 4
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Time frame: Baseline to Week 12
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Time frame: Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Time frame: Baseline to Week 4
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Wilson Liao, MD principal investigator
University of California, San Francisco
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 in people with Psoriasis, run by University of California, San Francisco at 1 site in United States.
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 9 inclusion and 12 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 Sep 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline (time frame: Baseline to Week 2). 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 16 Sep 2020.