Chronic Scalp PsoriasisPhase 3SCALPNCT02267135
Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis
A Phase 3 study testing Secukinumab 300 mg in people with Chronic Scalp Psoriasis, run by Novartis Pharmaceuticals at 17 sites in United States.
Trial summary
This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Scalp Psoriasis
- What is being tested?
- Secukinumab 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 17 sitesUnited States
- Study dates
- 29 Sep 2014to 7 Dec 2015
- 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
- Chronic scalp psoriasis for at least the previous six months
- Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected
- Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
Who cannot join
- Forms of psoriasis other than chronic plaque
- Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors)
- Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy)
- Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors
- Use of other investigational drugs within 30 days prior to study entry, or within a period of 5 half-lives of the investigational treatment, whichever is longer
- Active, ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab
- Active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Novartis Investigative Site
Andover, Massachusetts, 01810
Novartis Investigative Site
Arlington, Texas, 76011
Novartis Investigative Site
Aurora, Colorado, 80045
Novartis Investigative Site
Boston, Massachusetts, 02114
Novartis Investigative Site
East Windsor, New Jersey, 08520
Novartis Investigative Site
Gahanna, Ohio, 43230
Novartis Investigative Site
Hershey, Pennsylvania, 17033
Novartis Investigative Site
New York, New York, 10025
Novartis Investigative Site
New York, New York, 10075
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213-3403
Novartis Investigative Site
Rockville, Maryland, 20850
Novartis Investigative Site
Sacramento, California, 95819
Novartis Investigative Site
Salt Lake City, Utah, 84132
Novartis Investigative Site
Troy, Michigan, 48084
Novartis Investigative Site
Trumbull, Connecticut, 06611
Novartis Investigative Site
West Jordan, Utah, 84088
Novartis Investigative Site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Efficacy of Subcutaneous Secukinumab [300 mg] as Assessed by the Psoriasis Scalp Severity Index (PSSI) at 12 Weeks of Treatment, Compared to Placebo, and to Assess Safety and Tolerability up to 24 Weeks in Adult Subjects With Moderate to Severe Scalp Psoriasis
This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments.
- Conditions
- Chronic Scalp Psoriasis
- Being tested
- Secukinumab 300 mg, Placebo
- Keywords
- scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, psoriasis, AIN457A
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab 300 mgBiological
Also called AIN457 300 mg
Secukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 20 inclusive. In order to maintain the blinding, patients will receive additional placebo injections at Weeks 13, 14 and 15. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur of days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
PlaceboBiological
Placebo will be provided in 1 mL prefilled syringe. Each placebo dose will consist of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3 and 4), then after four weeks at Week 8. At Week 12, PSSI responders will continue on placebo and receive their injections once weekly for five weeks (Weeks 12, 13, 14, 15 and 16), then followed by dosing after four weeks at Week 20. PSSI non-responders will be switched to receive 300 mg secukinumab at Weeks 12, 13, 14, 15 and 16, then after four weeks at Week 20. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | Eligible patients will receive secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive Receives: Biological: Secukinumab 300 mg |
| Placebo | Placebo comparator | Eligible patients will receive placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, the patient will be assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the subject is a responder, the subject will continue on placebo dosing weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. Subjects who are not responders will be switched to treatment with secukinumab 300 mg and will dose once weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Scalp Severity Index 90 (PSSI 90)
PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis
Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of "yes"
Measured: 12 weeks
Secondary outcomes (12)
Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)
IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis
Measured: 12 weeks
Change From Baseline in PSSI Score
Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe
Measured: 12 weeks
Psoriasis Scalp Severity Index 75 (PSSI 75) Response
PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis
Measured: 12 weeks
Psoriasis Scalp Severity Index 100 (PSSI 100) Response
PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis
Measured: 12 weeks
Time to 50% Reduction in PSSI Score up to Week 12
Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm
The median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo
Measured: 12 weeks
Psoriasis Area and Severity Index 75 (PASI 75)
PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis
Measured: 12 weeks
Psoriasis Area and Severity Index 90 (PASI 90)
PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis
Measured: 12 weeks
Psoriasis Area and Severity Index 100 (PASI 100)
PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis
Measured: 12 weeks
Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)
IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis
Measured: 12 weeks
Change From Baseline in Subject Assessment of Pain
Change from baseline in the Subject Assessment of Pain
Scale of 0-10 with 10 being the most painful
Measured: 12 weeks
Change From Baseline in Subject Assessment of Itching
Change from baseline in the Subject Assessment of Itching
Scale of 0-10 with 10 being the most itchy
Measured: 12 weeks
Change From Baseline in Subject Assessment of Scaling (Scalp Only)
Change from baseline in the Subject Assessment of Scaling (scalp only)
Scale of 0-10 with 10 being the most scaling
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start29 Sep 2014
- Primary completion7 Dec 2015
- Study completion7 Dec 2015
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 Chronic Scalp PsoriasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267135
- Sponsor's protocol ID
- CAIN457AUS01
- Acronym
- SCALP
- Status last verified
- Mar 2019
- First submitted
- 30 Sep 2014
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Efficacy of Subcutaneous Secukinumab [300 mg] as Assessed by the Psoriasis Scalp Severity Index (PSSI) at 12 Weeks of Treatment, Compared to Placebo, and to Assess Safety and Tolerability up to 24 Weeks in Adult Subjects With Moderate to Severe Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT02267135
- Acronym / sponsor ID
- SCALP / CAIN457AUS01
- Conditions
- Chronic Scalp Psoriasis
- Keywords
- scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, psoriasis, AIN457A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2014 (actual)
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 7 Dec 2015 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Posted 28 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Biological: Secukinumab 300 mgEligible patients will receive secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive |
| Placebo | Placebo comparator | Biological: PlaceboEligible patients will receive placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, the patient will be assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the subject is a responder, the subject will continue on placebo dosing weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. Subjects who are not responders will be switched to treatment with secukinumab 300 mg and will dose once weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic scalp psoriasis for at least the previous six months
- Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected
- Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
Key exclusion criteria (8 listed)
- Forms of psoriasis other than chronic plaque
- Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors)
- Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy)
- Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors
- Use of other investigational drugs within 30 days prior to study entry, or within a period of 5 half-lives of the investigational treatment, whichever is longer
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 300 mgAlso: AIN457 300 mgSecukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 20 inclusive. In order to maintain the blinding, patients will receive additional placebo injections at Weeks 13, 14 and 15. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur of days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home. | Biological | Secukinumab |
| PlaceboPlacebo will be provided in 1 mL prefilled syringe. Each placebo dose will consist of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3 and 4), then after four weeks at Week 8. At Week 12, PSSI responders will continue on placebo and receive their injections once weekly for five weeks (Weeks 12, 13, 14, 15 and 16), then followed by dosing after four weeks at Week 20. PSSI non-responders will be switched to receive 300 mg secukinumab at Weeks 12, 13, 14, 15 and 16, then after four weeks at Week 20. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home. | Biological | Placebo |
Primary outcome
Psoriasis Scalp Severity Index 90 (PSSI 90)
Time frame: 12 weeks
PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of "yes"
12 secondary outcomes
Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)
Time frame: 12 weeks
Change From Baseline in PSSI Score
Time frame: 12 weeks
Psoriasis Scalp Severity Index 75 (PSSI 75) Response
Time frame: 12 weeks
Psoriasis Scalp Severity Index 100 (PSSI 100) Response
Time frame: 12 weeks
Time to 50% Reduction in PSSI Score up to Week 12
Time frame: 12 weeks
Psoriasis Area and Severity Index 75 (PASI 75)
Time frame: 12 weeks
Psoriasis Area and Severity Index 90 (PASI 90)
Time frame: 12 weeks
Psoriasis Area and Severity Index 100 (PASI 100)
Time frame: 12 weeks
Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)
Time frame: 12 weeks
Change From Baseline in Subject Assessment of Pain
Time frame: 12 weeks
Change From Baseline in Subject Assessment of Itching
Time frame: 12 weeks
Change From Baseline in Subject Assessment of Scaling (Scalp Only)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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.
Novartis Pharmaceuticals study director
Novartis
17 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 300 mg in people with Chronic Scalp Psoriasis, run by Novartis Pharmaceuticals at 17 sites 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 3 inclusion and 8 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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. Some participants in this study may receive a placebo. 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 28 Feb 2018). 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?
Psoriasis Scalp Severity Index 90 (PSSI 90) (time frame: 12 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 5 Jan 2021.