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PsoriasisPhase 3STYLENCT03123471

A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

A Phase 3 study testing Apremilast in people with Psoriasis, run by Amgen at 45 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Apremilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
303 participants
Where
45 sitesin 2 countries
Study dates
16 May 2017to 9 Jan 2019
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

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Males or females, ≥ 18 years of age at the time of signing the informed consent document
  • Be willing and able to adhere to the study visit schedule and other protocol requirements.
  • Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening and baseline
  • Must be a candidate for phototherapy and/or systemic therapy for either body or scalp psoriasis lesions.
  • Have moderate to severe plaque psoriasis at screening and baseline
Show all 12Show fewer
  • Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratories, and urinalysis
  • Must meet laboratory criteria
  • Females of childbearing potential (FCBP)* must have a negative pregnancy test at screening and baseline. While on investigational product (IP) and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible - must use one of the approved contraceptive** options described below:
  • Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
  • A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
  • The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

Who cannot join

  • The presence of any of the following will exclude a subject from enrollment:
  • Other than psoriasis, history of any clinically significant uncontrolled disease.
  • Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
  • Pregnant or breast feeding
  • Hepatitis B surface antigen positive at screening
  • Anti-hepatitis C antibody positive at screening
Show all 19Show fewer
  • Active tuberculosis (TB) or a history of incompletely treated TB
  • Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
  • History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)
  • Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent form.
  • Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of signing the informed consent form.
  • Malignancy or history of malignancy, except for treated (i.e., cured) basal cell or squamous cell in situ skin carcinomas or treated (i.e., cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.
  • 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.
  • Psoriasis flare/rebound within 4 weeks of signing the informed consent form or between the screening and baseline visits.
  • Topical therapy within 2 weeks prior to randomization; Conventional systemic therapy for psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids on the scalp within 2 weeks prior to randomization; Phototherapy treatment of body or scalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between 12 weeks to 24 weeks prior to randomization
  • Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
  • Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
  • Prior treatment with apremilast
  • History of allergy or hypersensitivity to any components of the Investigational product.

Trial locations and contacts

45 sites in 2 countries.

45 sites in 2 countries

United States32 sites

  • Austin Dermatology Associates

    Austin, Texas, 78705

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Florida Academic Centers Research and Education

    Coral Gables, Florida, 33134

  • Modern Research Associates PLLC

    Dallas, Texas, 75231

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • Wright State Physicians

    Fairborn, Ohio, 45324

  • University of Connecticut

    Farmington, Connecticut, 06030

  • Forest Hills Dermatology Group

    Forest Hills, New York, 11375

  • Tien Q. Nguyen MD Inc

    Fountain Valley, California, 92708

  • Dermatology and Advanced Aesthetics

    Lake Charles, Louisiana, 70605

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • DS Research

    Louisville, Kentucky, 40202

  • DS Research

    Louisville, Kentucky, 40241

  • Dermatologic Surgery Specialists, P.C.

    Macon, Georgia, 31217

  • International Dermatology Research

    Miami, Florida, 33144

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Icahn School of Medicine at Mount Sinai Medical Center

    New York, New York, 10029

  • Sadick Research Group

    New York, New York, 10075

  • MedaPhase INC

    Newnan, Georgia, 30263

  • Virginia Clinical Research Inc

    Norfolk, Virginia, 23502

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Skin Specialists, PC

    Omaha, Nebraska, 68144

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana, 46168

  • Lawrence Green, MD, LLC

    Rockville, Maryland, 20850

  • Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology

    Rogers, Arkansas, 72758

  • University of Utah

    Salt Lake City, Utah, 84107

  • San Luis Dermatology and Laser Clinic

    San Luis Obispo, California, 93405

  • Central Dermatology

    St Louis, Missouri, 63117

  • Center for Clinical Studies

    Webster, Texas, 77598

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27104

Other trials in United States

Canada13 sites

  • Kirk Barber Research

    Calgary, Alberta, T2G 1B1

  • Institute for Skin Advancement

    Calgary, Alberta, T3A 2N1

  • Lynderm Research

    Markham, Ontario, L3P1X2

  • North Bay Dermatology Center

    North Bay, Ontario, P1B 3Z7

  • Skin Center for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

    Québec, G1V 4X7

  • Centre For Dermatology and Cosmetic Surgery

    Richmond Hill, Ontario, L4B 1A5

  • Chih-Ho Hong Medical, Inc.

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research

    Surrey, British Columbia, V3V 0C6

  • The Toronto Dermatology Centre

    Toronto, Ontario, M3H 5Y8

  • K. Papp Clinical Research

    Waterloo, Ontario, N2J 1C4

  • XLR8 Medical Research

    Windsor, Ontario, N8W 1E6

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

About this study

Official title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp.

Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.

Read the detailed description

The study will consist of four phases:

  • Screening Phase - up to 35 days
  • Double-blind Placebo-controlled Phase- Weeks 0 to 16 Subjects will receive treatment with one of the following:
  • apremilast 30 mg tablets orally BID or
  • placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID
  • Apremilast Extension Phase - Weeks 16 to 32
  • All subjects who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID (or continue with) apremilast. At Week 16, all subjects will maintain this dosing through Week 32.
  • Observational Follow-up Phase
  • Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early.
Conditions
Psoriasis
Being tested
Apremilast, Placebo
Keywords
Plaque Psoriasis, Scalp, Double-Blind, Efficacy, Safety, CC-10004, Apremilast, Otezla, Itch, Head
Medical subject headings
Psoriasis, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApremilastDrug

    Also called CC-10004

    Apremilast 30 mg tablets BID from weeks 0 to 32.

  • PlaceboOther

    Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.

Study groups in NCT03123471
Study groupRoleWhat they receive
Apremilast 30 mg BIDExperimentalApremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32
Receives: Drug: Apremilast; Other: Placebo
PlaceboPlacebo comparatorPlacebo tablets BID during weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 16 weeks (from Week 16 to Week 32)
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline

    The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions.

    Measured: Baseline to Week 16

Secondary outcomes (8)

  1. Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16

    The Whole Body Itch NRS scale is an 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity. NRS response was defined as a ≥ 4-point reduction (improvement) from baseline.

    Measured: Baseline to Week 16

  2. Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16

    The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

    Measured: Baseline to Week 16

  3. Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase

    The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.

    Measured: Baseline to Weeks 2, 4, 6, 8 and 12

  4. Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase

    The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

    Measured: Baseline to Weeks 2, 4, 8 and 12

  5. Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16

    DLQI is questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, and has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

    Measured: Baseline to Week 16

  6. Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase

    A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.

    Measured: Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.

  7. Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase

    A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.

    Measured: Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively

  8. Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period

    The apremilast-exposure period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.

    Measured: Week 0 to 32;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2017
  2. Study start16 May 2017
  3. Primary completion13 Aug 2018
  4. Study completion9 Jan 2019

Resources

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
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03123471
Sponsor's protocol ID
CC-10004-SPSO-001
Other IDs
U1111-1194-1248
Acronym
STYLE
Status last verified
Apr 2020
First submitted
18 Apr 2017
Last updated
13 May 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Expanded access
Available

Publications

  • Strober B, Lebwohl M, van de Kerkhof P, Gold LS, Merola JF, Okubo Y, Gisondi P, Zhou Z, Chaudhari S, Deignan C, Mrowietz U. Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01921-9. Online ahead of print.

    PubMed 42825996

  • Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.

    PubMed 37316690

  • Wang Y, Coyne K, Sofen H, Santanello N, Currie B, Zhang Z, Nograles K. Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp. J Dermatolog Treat. 2019 Dec;30(8):775-783. doi: 10.1080/09546634.2019.1577546. Epub 2019 Mar 5.

    PubMed 30747550

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apremilast in people with Psoriasis, run by Amgen at 45 sites in 2 countries.

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 12 inclusion and 19 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 13 May 2020. 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 United States, Canada. 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 4 Sep 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 Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03123471, which also lists 3 linked publications.

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 13 May 2020.

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