Plaque Type PsorisisPhase 3SUPREMENCT02394561
A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
A Phase 3 study testing Secukinumab in people with Plaque Type Psorisis, run by Novartis Pharmaceuticals at 45 sites in Italy.
Trial summary
A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Type Psorisis
- What is being tested?
- Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 45 sitesItaly
- Study dates
- 10 Apr 2015to 8 Jun 2017
- Phase
- Phase 3
- 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
- Subject must have been able to understand and communicate with the investigator and to comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed.
- Men or women at least 18 years of age at time of screening.
- Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months (including concomitant psoriatic arthritis as per the Classification Criteria for Psoriatic Arthritis criteria [CASPAR]).
- Moderate to severe psoriasis as defined at enrollment by:
- PASI score ≥ 10 or
- PASI score > 5 but < 10 and DLQI ≥10
- Patients that are candidates for systemic therapy, whether treatment naïve or after failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFα (or is intolerant and/or has a contraindication to these).
Who cannot join
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis).
- Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.
- Anti-TNFα therapy within timelines depending on drug half-life.
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
- Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that was not anti-TNFα therapy.
- Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening.
- Ongoing use of corticosteroid topical treatments or UV therapy.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Italy45 sites
Novartis Investigative Site
Ancona, AN, 60126
Novartis Investigative Site
Bari, BA, 70124
Novartis Investigative Site
Benevento, BN, 82100
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Brindisi, BR, 72100
Novartis Investigative Site
Cagliari, CA, 09124
Novartis Investigative Site
Catania, CT, 95123
Novartis Investigative Site
Catanzaro, CZ, 88100
Novartis Investigative Site
Chieti, CH, 66100
Novartis Investigative Site
Erice, TP, 91016
Novartis Investigative Site
Florence, FI, 50122
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Grosseto, GR, 58100
Novartis Investigative Site
L’Aquila, AQ, 67100
Novartis Investigative Site
Lecce, LE, 73100
Novartis Investigative Site
Lucca, LU, 55100
Novartis Investigative Site
Mantua, MN, 46100
Novartis Investigative Site
Messina, ME, 98158
Novartis Investigative Site
Milan, (MI), 20161
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Modena, MO, 41124
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Perugia, PG, 06100
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Province of Macerata, MC, 62100
Novartis Investigative Site
Reggio Emilia, RE, 42123
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site
Roma, RM, 00144
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Roma, RM, 00167
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
San Donato Milanese, MI, 20097
Novartis Investigative Site
Siena, SI, 53100
Novartis Investigative Site
Terni, TR, 05100
Novartis Investigative Site
Terracina, LT, 04019
Novartis Investigative Site
Torino, TO, 10126
Novartis Investigative Site
Trieste, TS, 34129
Novartis Investigative Site
Udine, UD, 33100
Novartis Investigative Site
Verona, VR, 37126
About this study
A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis
Read the detailed description
Biological agents represent the most advanced type of treatment for psoriasis. Secukinumab is a human monoclonal anti IL-17A antibody that binds to human IL-17A and neutralizes its bioactivity by inhibiting IL17A produced by both Th17 cells and those of the innate immune system, thus providing complete anti IL17A blockage. Targeting IL-17A has the potential to reduce autoimmune inflammation while leaving other immune functions undisturbed. While targeting of Th1-promoting or Th17-promoting cytokines affects critical mediators such as IFN-γ, IL-22 and IL-21, selective targeting of IL-17A leaves these Th1/17 activities, as well as certain protective functions of innate cells intact. Furthermore, as a fully human monoclonal antibody, secukinumab should reduce immunogenic risks compared to current or emerging antibody therapies that are not fully human.
Many recent studies have shown that highly selective biologic drugs are not effective in every patient and that variations in the genome can be associated with different clinical responses or side effects to a given drug. The PSORS1 locus on chromosome 6p is generally understood to confer the most risk for psoriasis. A specific allele for this locus, HLA C*06, is present in about 60% of psoriatic patient cases. Data linking secukinumab efficacy to a particular genetic marker are lacking.
Recent research has revealed a marked difference in the proportion of PASI 90 achievers at 12 weeks between Cw6-positive and Cw6-negative patients (85.7% vs 56.5%) treated with ustekinumab (Talamonti M et al. 2013) and a greater efficacy of anti-TNFα drugs in CW6 negative patients (Galli et al. 2013).Unlike anti-IL-12/23 agents, secukinumab inhibits IL-17 produced by both Th17 cells after presentation by antigen presenting cells (in this case Cw6) and cells of the innate immune system whose activation does not require antigen presentation. Providing a drug that is equally effective on both Cw6-negative and Cw6-positive patients would be an important clinical accomplishment and would eliminate the need for costly HLA-Cw6 tests. The choice of a cohort study would therefore seem appropriate for this clinical context.
The purpose of this study was to explore the different efficacy and safety profile of secukinumab 300 mg in patients with moderate to severe chronic plaque-type psoriasis, stratified for the presence of HLA-C*06, whose determination was blinded for patients and investigators. The study was conducted both on anti-TNFα-naïve and anti-TNFα failure patients and also stratified for TNFα - 308 polymorphism, BMI, smoking and metabolic syndrome, among others.
- Conditions
- Plaque Type Psorisis
- Being tested
- Secukinumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabBiological
Also called AIN457
Secukinumab was supplied as 150 mg solution in pre-filled syringe for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cw6-positive AIN457 300 mg | Experimental | Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks Receives: Biological: Secukinumab |
| Cw6-negative AIN457 300 mg | Experimental | Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks Receives: Biological: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)
PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.
Measured: Baseline up to 16 weeks
Secondary outcomes (9)
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0).
Measured: Baseline up to approximately 72 weeks
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT)
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe').
Measured: Baseline up to approximately 72 weeks
Median Time to Reach PASI 90 and 75 (ITT)
Time in days to reach PASI scores of 90 and 75.
Measured: Baseline up to approximately 72 weeks
Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)
The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort
Measured: Baseline up to approximatly 72 weeks
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not at all = 3 in the reverse order. The HADS consisted of two sub-scores: the HAD-A (anxiety) and HAD-D (depression); each sub-score ranged from 0 to 21 points; scores ≥11 = presence of anxious or depressive disorders; scores between 8-10 points = borderline abnormal, and scores of ≤7 = disorder was not present. It was pre-specified that results would be presented for all patients, not by cohort
Measured: Baseline up approximately 72 weeks
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)
PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort
Measured: Baseline up to approximately 72 weeks
Changes From Baseline in Body Mass Index (Safety Set)
Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit
Measured: Baseline up to approximately 72 weeks
Changes From Baseline in Waist Circumference (Safety Set)
Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit
Measured: Baseline up to approximately 72 weeks
Changes From Baseline in Weight (Safety Set)
Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit
Measured: Baseline up to approximately 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start10 Apr 2015
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
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 Plaque Type PsorisisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Arms represent stratification of Cw6 positive and Cw6 negative patients
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394561
- Sponsor's protocol ID
- CAIN457AIT01
- Acronym
- SUPREME
- Status last verified
- Apr 2019
- First submitted
- 25 Feb 2015
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
- ClinicalTrials.gov ID
- NCT02394561
- Acronym / sponsor ID
- SUPREME / CAIN457AIT01
- Conditions
- Plaque Type Psorisis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 23 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis
Detailed description
Biological agents represent the most advanced type of treatment for psoriasis. Secukinumab is a human monoclonal anti IL-17A antibody that binds to human IL-17A and neutralizes its bioactivity by inhibiting IL17A produced by both Th17 cells and those of the innate immune system, thus providing complete anti IL17A blockage. Targeting IL-17A has the potential to reduce autoimmune inflammation while leaving other immune functions undisturbed. While targeting of Th1-promoting or Th17-promoting cytokines affects critical mediators such as IFN-γ, IL-22 and IL-21, selective targeting of IL-17A leaves these Th1/17 activities, as well as certain protective functions of innate cells intact. Furthermore, as a fully human monoclonal antibody, secukinumab should reduce immunogenic risks compared to current or emerging antibody therapies that are not fully human.
Many recent studies have shown that highly selective biologic drugs are not effective in every patient and that variations in the genome can be associated with different clinical responses or side effects to a given drug. The PSORS1 locus on chromosome 6p is generally understood to confer the most risk for psoriasis. A specific allele for this locus, HLA C*06, is present in about 60% of psoriatic patient cases. Data linking secukinumab efficacy to a particular genetic marker are lacking.
Recent research has revealed a marked difference in the proportion of PASI 90 achievers at 12 weeks between Cw6-positive and Cw6-negative patients (85.7% vs 56.5%) treated with ustekinumab (Talamonti M et al. 2013) and a greater efficacy of anti-TNFα drugs in CW6 negative patients (Galli et al. 2013).Unlike anti-IL-12/23 agents, secukinumab inhibits IL-17 produced by both Th17 cells after presentation by antigen presenting cells (in this case Cw6) and cells of the innate immune system whose activation does not require antigen presentation. Providing a drug that is equally effective on both Cw6-negative and Cw6-positive patients would be an important clinical accomplishment and would eliminate the need for costly HLA-Cw6 tests. The choice of a cohort study would therefore seem appropriate for this clinical context.
The purpose of this study was to explore the different efficacy and safety profile of secukinumab 300 mg in patients with moderate to severe chronic plaque-type psoriasis, stratified for the presence of HLA-C*06, whose determination was blinded for patients and investigators. The study was conducted both on anti-TNFα-naïve and anti-TNFα failure patients and also stratified for TNFα - 308 polymorphism, BMI, smoking and metabolic syndrome, among others.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arms represent stratification of Cw6 positive and Cw6 negative patients
| Arm | Type | Receives |
|---|---|---|
| Cw6-positive AIN457 300 mg | Experimental | Biological: SecukinumabStratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks |
| Cw6-negative AIN457 300 mg | Experimental | Biological: SecukinumabStratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must have been able to understand and communicate with the investigator and to comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed.
- Men or women at least 18 years of age at time of screening.
- Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months (including concomitant psoriatic arthritis as per the Classification Criteria for Psoriatic Arthritis criteria [CASPAR]).
- Moderate to severe psoriasis as defined at enrollment by:
- Patients that are candidates for systemic therapy, whether treatment naïve or after failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFα (or is intolerant and/or has a contraindication to these).
Key exclusion criteria (7 listed)
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis).
- Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.
- Anti-TNFα therapy within timelines depending on drug half-life.
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
- Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that was not anti-TNFα therapy.
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: AIN457Secukinumab was supplied as 150 mg solution in pre-filled syringe for subcutaneous injection | Biological | Cw6-negative AIN457 300 mg, Cw6-positive AIN457 300 mg |
Primary outcome
Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)
Time frame: Baseline up to 16 weeks
PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.
9 secondary outcomes
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)
Time frame: Baseline up to approximately 72 weeks
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT)
Time frame: Baseline up to approximately 72 weeks
Median Time to Reach PASI 90 and 75 (ITT)
Time frame: Baseline up to approximately 72 weeks
Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)
Time frame: Baseline up to approximatly 72 weeks
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS)
Time frame: Baseline up approximately 72 weeks
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)
Time frame: Baseline up to approximately 72 weeks
Changes From Baseline in Body Mass Index (Safety Set)
Time frame: Baseline up to approximately 72 weeks
Changes From Baseline in Waist Circumference (Safety Set)
Time frame: Baseline up to approximately 72 weeks
Changes From Baseline in Weight (Safety Set)
Time frame: Baseline up to approximately 72 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab in people with Plaque Type Psorisis, run by Novartis Pharmaceuticals at 45 sites 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 7 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 23 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 45 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 Apr 2019). 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?
Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set) (time frame: Baseline up to 16 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 23 Apr 2019; AzTrials last refreshed its copy on 26 Oct 2026.