Scalp PsoriasisPhase 4NCT01558310
A Study to Evaluate the Effectiveness of STELARA ™ (USTEKINUMAB) in the Treatment of Scalp Psoriasis
A Phase 4 study testing Ustekinumab in people with Scalp Psoriasis and Plaque Psoriasis, run by Paul Steven Yamauchi, MD, PhD at 1 site in United States.
Trial summary
This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of scalp psoriasis by determining the proportion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Psoriasis, Plaque Psoriasis
- What is being tested?
- Ustekinumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2013
- 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
- Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
- Be 18 years of age or older at the time of consent; may be male or female.
- Have had a diagnosis of plaque psoriasis at least 6 months prior to administration of study agent.
- Presence of moderate or severe psoriasis on the body other than the scalp.
- At least 30% of scalp affected with erythema, induration and desquamation and s-PGA score greater than or equal to 4.
- Be candidates for phototherapy or systemic treatment of psoriasis.
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- Women of childbearing potential and all men must be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue use of such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study agent.
- Be able to adhere to protocol requirements and study visit schedule.
- Must agree not to receive a live virus or live bacterial vaccination during the trial and 12 months after last study injection.
- Must agree not to receive a BCG vaccination during the trial and up to 12 months after the last injection.
- Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
- Are considered eligible according to the following tuberculosis (TB) screening criteria:
- Have no history of latent or active TB prior to screening. An exception is made for subjects currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
- Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
- Within 6 weeks prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result (see Attachment #).Indeterminate results should be handled as outlined in Section #, Exclusion Criteria.
- Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
- Have screening laboratory test results within the following parameters:
- Hemoglobin > 10g/dL
- White Blood Cells > 3.5 x 109 /L
- Neutrophils > 1.5 x 109 /L
- Platelets > 100 X109 /L
- Serum Creatinine < 1.5 mg/dL ( or 133 micromol/L )
- AST,ALT, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range for the laboratory conducting the test
Who cannot join
- Subjects meeting any of the following criteria may not be enrolled in the study:
- Currently have non-plaque forms of psoriasis (erythrodermic, guttate, or pustular).
- Have current drug-induced psoriasis.
- Presence of any skin conditions ( including scalp) other than psoriasis that would interfere with evaluations of the effect of study agents.
- Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study.
- Have used any therapeutic agent targeted at reducing IL-12 and/or IL-23, including but not limited to ustekinumab and ABT -874.
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- Have used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent, whatever is longer.
- Have used any investigational drug within the previous 3 months or 5 times the half-life of the biological, whichever is longer.
- Have ever received natalizumab or other agents that target alpha-4-integrin.
- Have received phototherapy or any any systemic medications/treatments that could affect psoriasis or s-PGA/PASI evaluations ( including but not limited to, oral or injectable corticosteroids, retinoids,1,25 dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of administration of study agent.
- Have used topical mediations/treatments that could affect psoriasis or s-PGA/PASI evaluation ( eg corticosteroids , anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen,trimethylpsoralens) within 2 weeks of the first administration of study agent.
- Have used any systemic immunosuppressants ( eg Methotrexate, azathioprine, cyclosporine,6-thioguanine, mercaptopurine, mycophenolate, mofetil, hydroxyurea, and tacrolimus) within 4 weeks of the first administration of study agent.
- Are currently receiving lithium, anti-malarials, or intramuscular gold, or have received lithium, anti-malarials, or intramuscular gold, or have received lithium, anti-malarials, or intramuscular gold within 4 weeks of the first administration of study agent.
- Have received within 3 months prior to the first injection a live virus or bacterial vaccination. Subjects must agree not to receive a live virus or bacterial vaccination during the trial or up to 12 month after the last study agent injection.
- Have had a BCG vaccination within 12 months of screening. Subject must agree not to receive a BCG vaccination during the trial or up to 12 months after the last study agent injection.
- Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infections (eg bronchiectasis), recurrent urinary tract infections (recurrent pyelonephritis or chronic non-remitting cystitis), or open, draining, or infected skin wounds or ulcers.
- Have or have had a serious infection (eg sepsis, pneumonia,or pyelonephritis) or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening
- Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening.
- Have persistently indeterminate (indeterminate on repeat sampling) QuantiFERON-TB Gold test results
- Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
- Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB.
- Have had a non-tuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening.
- Known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C.
- Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
- Have a transplanted organ.
- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and /or splenomegaly.
- Have a known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin or cervix that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent).
- Have been hospitalized in the past 3 years for asthma, ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or required more than one short -term (< 2 weeks) course of oral corticosteroids for asthma within the previous year.
- Have undergone allergy immunotherapy previously for prevention of anaphylactic reactions.
- Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product (eg plasma derived or recombinant monoclonal antibody).
- Be known to have had a substance abuse (drug or alcohol) problem within the previous 12 months.
- Be participating in another trial using an investigational agent or procedure during participation in the trial.
- Use of tar shampoos within 14 days of first dose of study drug.
- Use of OTC shampoos for scalp psoriasis will not be allowed during study.
- Use of topical corticosteroids or other topical agents for the treatment of psoriasis on the scalp will not be allowed during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Science Institute
Santa Monica, California, 90404
PAUL YAMAUCHI, MD,PhD, 310-828-8887, paulyamauchi@yahoo.com
PAUL YAMAUCHI, MD,PhD
About this study
Official title: A Double - Blind, Placebo Controlled Crossover Study to Evaluate The Efficacy and Tolerability of Stelara ™ (Ustekinumab) in The Treatment of Scalp Psoriasis
This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of scalp psoriasis by determining the proportion of subjects who clear or almost clear in scalp specific physician assessments. The study will include approximately 30 subjects.
- Conditions
- Scalp Psoriasis, Plaque Psoriasis
- Being tested
- Ustekinumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. Group B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses
PlaceboDrug
Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52.The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses Receives: Drug: Ustekinumab; Drug: Placebo |
| Group B | Placebo comparator | Group B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses Receives: Drug: Ustekinumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
s-PGA ( Scalp specific Physician Global Assessment) at Week 12
s-PGA (Scalp specific Physician Global Assessment) is a 7 point scale ranging from 0 (Clear = No signs of psoriasis ) to 6 (Severe = Very marked plaque elevation, scaling, and/or erythema)
Measured: Week 12 (8 weeks after the second of two SC doses of ustekinumab)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp PsoriasisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Steven Yamauchi, MD, PhD
- Collaborators
- Janssen Services, LLC
- Responsible party
- Sponsor-investigator, Paul Steven Yamauchi, MD, PhD, Yamauchi, Paul Steven, M.D., Ph.D.
- Investigators
- PAUL S YAMAUCHI, MD,PhD, Principal investigator, Clinical Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558310
- Sponsor's protocol ID
- CSI ScalpPsor 012011
- Status last verified
- Jul 2012
- First submitted
- 13 Mar 2012
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double - Blind, Placebo Controlled Crossover Study to Evaluate The Efficacy and Tolerability of Stelara ™ (Ustekinumab) in The Treatment of Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT01558310
- Acronym / sponsor ID
- CSI ScalpPsor 012011
- Conditions
- Scalp Psoriasis, Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Paul Steven Yamauchi, MD, PhD
- Collaborators
- Janssen Services, LLC
- Study start
- Aug 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Mar 2012 (estimated)
- 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 is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of scalp psoriasis by determining the proportion of subjects who clear or almost clear in scalp specific physician assessments. The study will include approximately 30 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Ustekinumab, Drug: PlaceboSubjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52.The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses |
| Group B | Placebo comparator | Drug: Ustekinumab, Drug: PlaceboGroup B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
- Be 18 years of age or older at the time of consent; may be male or female.
- Have had a diagnosis of plaque psoriasis at least 6 months prior to administration of study agent.
- Presence of moderate or severe psoriasis on the body other than the scalp.
- At least 30% of scalp affected with erythema, induration and desquamation and s-PGA score greater than or equal to 4.
Key exclusion criteria (35 listed)
- Currently have non-plaque forms of psoriasis (erythrodermic, guttate, or pustular).
- Have current drug-induced psoriasis.
- Presence of any skin conditions ( including scalp) other than psoriasis that would interfere with evaluations of the effect of study agents.
- Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study.
- Have used any therapeutic agent targeted at reducing IL-12 and/or IL-23, including but not limited to ustekinumab and ABT -874.
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 |
|---|---|---|
| UstekinumabSubjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. Group B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses | Drug | Group A, Group B |
| PlaceboSubjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses | Drug | Group A, Group B |
Primary outcome
s-PGA ( Scalp specific Physician Global Assessment) at Week 12
Time frame: Week 12 (8 weeks after the second of two SC doses of ustekinumab)
s-PGA (Scalp specific Physician Global Assessment) is a 7 point scale ranging from 0 (Clear = No signs of psoriasis ) to 6 (Severe = Very marked plaque elevation, scaling, and/or erythema)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
Related trials for Scalp Psoriasis
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A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)
Plaque Psoriasis
RecruitingPhase 4
Immune Spatial Features of Guselkumab Cutaneous Response
Psoriasis of Scalp
Not yet recruitingObservational study
Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)
Plaque Psoriasis, Psoriatic Arthritis
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.
PAUL S YAMAUCHI, MD,PhD principal investigator
Clinical Science Institute
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 Ustekinumab in people with Scalp Psoriasis and Plaque Psoriasis, run by Paul Steven Yamauchi, MD, PhD 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 23 inclusion and 35 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 18 Jul 2012. 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. 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 PAUL S YAMAUCHI, MD,PhD (3108288887, paulyamauchi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
s-PGA ( Scalp specific Physician Global Assessment) at Week 12 (time frame: Week 12 (8 weeks after the second of two SC doses of ustekinumab)). 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 18 Jul 2012; AzTrials last refreshed its copy on 6 Nov 2026.