Psoriasis of ScalpPhase 4APRESCALPNCT03553433
Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis
A Phase 4 study testing Apremilast 30mg in people with Psoriasis of Scalp and Psoriasis Vulgaris, run by University of Zurich at 4 sites in Switzerland.
Trial summary
A phase 4 multicenter, randomized, placebo-controlled Study evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients with moderate-to-severe Scalp Psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis of Scalp, Psoriasis Vulgaris
- What is being tested?
- Apremilast 30mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesSwitzerland
- Study dates
- Jun 2018to Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18yrs);
- Signed informed consent
- Clinical diagnosis of chronic plaque psoriasis for at least 3 months as determined by the subject's medical history and confirmation of diagnosis through physical examination by the Investigator;
- Psoriatic lesions with DLQI >10 and involvement of >20% of the scalp and pruritus with a VAS score of > 50 (0-100);
- Candidate for systemic therapy;
- Females who are of child-bearing potential should be practicing birth control throughout the study and for 70 days after the last dose of study drug;
- Subject is judged to be in good health as determined by the Investigator based upon the results of medical history, laboratory profile and physical examination.
- Creatinine < 80 umol/l at Inclusion
Who cannot join
- Erythrodermic Ps, medication-induced or medication-exacerbated Ps or new onset guttate Ps or other skin conditions at the time of the screening visit (e.g. eczema) that would interfere with evaluations of the effect of the investigational product on Ps;
- Use of any anti-psoriatic therapy last administered less than 4 weeks of start of study drug such as
- Three months or 5 PK half-lives, whichever is longer, for biologics tumor necrosis factor (TNF) antagonists, interleukin (IL) 12/23/17 inhibitors or other biologic drugs
- 4 weeks for immunosuppressive / -modulating drugs including cyclosporine A, methotrexate, azathioprine, mycophenolate mofetil, fumaric acid esters, retinoids, JAK inhibitors, corticosteroids, any other experimental drug, etc.
- Topical medications (eg. Corticosteroids) except coal tar shampoo, and/or salicylic acid scalp preparations on scalp lesions.
- 4 weeks for phototherapy (ie, UVB, PUVA).
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- Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit;
- Positive serology for hepatitis B, hepatitis C, HIV indicating acute or chronic infection;
- Chronic recurring bacterial infections or active TB;
- Positive pregnancy test at Screening or at the Baseline visit;
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
- History of clinically significant alcohol or drug abuse in the last 12 months;
- Known hypersensitivity to the excipients of Otezla® as stated in the label;
- Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
- Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Inselspital
Bern
Nikhil Yawalkar, MD, +41 (31) 632 22 88, nikhil.yawalkar@insel.ch
CHUV
Lausanne
Curdin Conrad, MD, +41 21 314 0400, curdin.conrad@chuv.ch
KSSG
Sankt Gallen, Canton of St. Gallen
Antonio Cozzio, MD PhD, +41 71 494 20 30, antonio.cozzio@kssg.ch
Department of Dermatology, University Hospital Zurich
Zurich, 8091
About this study
Official title: A Phase 4 Multicenter, Randomized, Placebo-controlled Study Evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients With Moderate-to-severe Scalp Psoriasis
A phase 4 multicenter, randomized, placebo-controlled Study evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients with moderate-to-severe Scalp Psoriasis
Read the detailed description
The scalp is the most frequently affected body region in psoriasis. Scalp Psoriasis can impair the quality of life greatly due to pruritus. This is however not usually investigated as a primary outcome of treatments.
This study will investigate the effects of apremilast on the pruritus and quality of life and other patient reported outcomes in patients with scalp psoriasis.
- Conditions
- Psoriasis of Scalp, Psoriasis Vulgaris
- Being tested
- Apremilast 30mg, Placebo Oral Tablet
- Keywords
- apremilast, quality of life, pruritus, oral drug, placebo
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apremilast 30mgDrug
Also called Otezla
Anti-psoriatic drug
Placebo Oral TabletDrug
Also called Placebo
Indistinguishable tablets not containing apremilast, Placebo Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Apremilast 30mg bd Receives: Drug: Apremilast 30mg |
| Placebo Oral Tablet | Placebo comparator | Excipiens Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scalp VAS Pruritus assessment
Pruritus VAS Scale (0 - 100)
Measured: Weeks 16
Secondary outcomes (11)
Scalp VAS Pruritus assessment
Pruritus VAS Scale (0 - 100)
Measured: Weeks 0, 4, 32, 52
% BSA
Body surface area
Measured: Weeks 0, 4, 16, 32, 52
% BSA of scalp
Body surface area of scalp
Measured: Weeks 0, 4, 16, 32, 52
PrecisePASI
Psoriasis Area and Severity Index, modified to measure in percentages
Measured: Weeks 0, 4, 16, 32, 52
PGA
Physicians Global Assessment (0 - 5)
Measured: Weeks 0, 4, 16, 32, 52
Scalp-PGA
Physicians Global Assessment of the Scalp (0 - 5)
Measured: Weeks 0, 4, 16, 32, 52
DLQI
Skin related Quality of life (0 to 30)
Measured: Weeks 0, 4, 16, 32, 52
Scalpdex
23 items related to scalp symptoms
Measured: Weeks 0, 4, 16, 32, 52
PSSI
Psoriasis score measuring intensity on the scalp
Measured: Weeks 0, 4, 16, 32, 52
VAS pruritus assessment
Pruritus VAS Scale (0 - 100)
Measured: Weeks 0, 4, 16, 32, 52
EQ-5D
Health-related Quality of Life Instrument
Measured: Weeks 0, 4, 16, 32, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis of ScalpStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Navarini, MD PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553433
- Sponsor's protocol ID
- DER-USZ-AAN-021
- Acronym
- APRESCALP
- Status last verified
- Jun 2018
- First submitted
- 18 Apr 2018
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Multicenter, Randomized, Placebo-controlled Study Evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients With Moderate-to-severe Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT03553433
- Acronym / sponsor ID
- APRESCALP / DER-USZ-AAN-021
- Conditions
- Psoriasis of Scalp, Psoriasis Vulgaris
- Keywords
- apremilast, quality of life, pruritus, oral drug, placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 12 Jun 2018 (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.
A phase 4 multicenter, randomized, placebo-controlled Study evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients with moderate-to-severe Scalp Psoriasis
Detailed description
The scalp is the most frequently affected body region in psoriasis. Scalp Psoriasis can impair the quality of life greatly due to pruritus. This is however not usually investigated as a primary outcome of treatments.
This study will investigate the effects of apremilast on the pruritus and quality of life and other patient reported outcomes in patients with scalp psoriasis.
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 |
|---|---|---|
| Verum | Experimental | Drug: Apremilast 30mgApremilast 30mg bd |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletExcipiens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult (>18yrs);
- Signed informed consent
- Clinical diagnosis of chronic plaque psoriasis for at least 3 months as determined by the subject's medical history and confirmation of diagnosis through physical examination by the Investigator;
- Psoriatic lesions with DLQI >10 and involvement of >20% of the scalp and pruritus with a VAS score of > 50 (0-100);
- Candidate for systemic therapy;
Key exclusion criteria (15 listed)
- Erythrodermic Ps, medication-induced or medication-exacerbated Ps or new onset guttate Ps or other skin conditions at the time of the screening visit (e.g. eczema) that would interfere with evaluations of the effect of the investigational product on Ps;
- Use of any anti-psoriatic therapy last administered less than 4 weeks of start of study drug such as
- Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit;
- Positive serology for hepatitis B, hepatitis C, HIV indicating acute or chronic infection;
- Chronic recurring bacterial infections or active TB;
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 |
|---|---|---|
| Apremilast 30mgAlso: OtezlaAnti-psoriatic drug | Drug | Verum |
| Placebo Oral TabletAlso: PlaceboIndistinguishable tablets not containing apremilast, Placebo Oral Tablet | Drug | Placebo Oral Tablet |
Primary outcome
Scalp VAS Pruritus assessment
Time frame: Weeks 16
Pruritus VAS Scale (0 - 100)
11 secondary outcomes
Scalp VAS Pruritus assessment
Time frame: Weeks 0, 4, 32, 52
% BSA
Time frame: Weeks 0, 4, 16, 32, 52
% BSA of scalp
Time frame: Weeks 0, 4, 16, 32, 52
PrecisePASI
Time frame: Weeks 0, 4, 16, 32, 52
PGA
Time frame: Weeks 0, 4, 16, 32, 52
Scalp-PGA
Time frame: Weeks 0, 4, 16, 32, 52
DLQI
Time frame: Weeks 0, 4, 16, 32, 52
Scalpdex
Time frame: Weeks 0, 4, 16, 32, 52
PSSI
Time frame: Weeks 0, 4, 16, 32, 52
VAS pruritus assessment
Time frame: Weeks 0, 4, 16, 32, 52
EQ-5D
Time frame: Weeks 0, 4, 16, 32, 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- 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.
Alexander Navarini, MD PhD principal investigator
University of Zurich
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apremilast 30mg in people with Psoriasis of Scalp and Psoriasis Vulgaris, run by University of Zurich at 4 sites in Switzerland.
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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Navarini, MD PhD (0041442551111, alexander.navarini@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scalp VAS Pruritus assessment (time frame: Weeks 16). 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 12 Jun 2018.