A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life
NCT ID: NCT03774875
Last Updated: 2025-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
277 participants
INTERVENTIONAL
2019-03-28
2021-11-03
Brief Summary
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Detailed Description
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The study will consist of 4 phases:
* Screening Phase - up to 5 weeks (35 days)
* Double-blind Placebo-controlled Phase - Weeks 0 to 16 Participants will receive treatment with either apremilast or matched placebo.
* Apremilast Extension Phase - Weeks 16 through 52 All participants will be switched to (or continue with) apremilast at week 16 and will maintain this dosing through week 52.
* Post-treatment Observational Follow-up Phase 4-week post-treatment observational follow-up phase for all participants who complete the study on treatment or discontinue from the study treatment early.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Apremilast 30 mg
Participants will take apremilast 30 mg tablets orally twice a day for up to 52 weeks.
Apremilast
Apremilast 30 mg tablets taken orally twice a day.
Placebo / Apremilast 30 mg
Participants will take placebo tablets orally twice a day for 16 weeks. After week 16, participants will be switched to receive apremilast 30 mg twice daily until Week 52.
Apremilast
Apremilast 30 mg tablets taken orally twice a day.
Placebo
Placebo tablets taken orally twice a day
Interventions
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Apremilast
Apremilast 30 mg tablets taken orally twice a day.
Placebo
Placebo tablets taken orally twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
4. Subject has diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline, that cannot be controlled by topical therapy.
5. Subject has a PASI score ranging from ≥ 3 to ≤ 10 at baseline.
6. Subject has a DLQI score \> 10 at baseline.
7. Subject has presence of ≥ 1 clinical manifestations of plaque psoriasis, defined as at least one of the following:
1. Moderate to severe scalp psoriasis, defined as Scalp Physician Global Assessment (ScPGA) ≥ 3
2. Nail psoriasis, defined as onycholysis and onychodystrophy in at least 2 fingernails
3. Moderate to severe genital plaque psoriasis, defined as modified static Physicians Global Assessment of Genitalia (sPGA-G) ≥ 3
4. Moderate to severe palmoplantar psoriasis, defined as Palmoplantar Psoriasis Physicians Global Assessment (PPPGA) ≥ 3
5. Moderate to severe plaque psoriasis in visible locations (dorsal hand, face, neck, and hairline) with static Physicians Global Assessment (sPGA) ≥ 3
8. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories.
(NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions.)
9. Subject must have failed to respond to, or be contraindicated to, or intolerant to other systemic therapy, including, but not limited to, cyclosporine, methotrexate, acitretin, psoralen and ultraviolet-A-light (PUVA) fumaric acid esters or biologic therapies.
10. Subjects (in Italy only) must be non-responder to, contraindicated to, or intolerant to other systemic therapy (including cyclosporine, methotrexate, or PUVA) AND also be contraindicated to, or intolerant to biologics.
11. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product 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.
NOTE: Option 2 may not be acceptable as a highly effective contraception option in all countries per local guidelines/regulations.
Exclusion Criteria
1. Subject has any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, erythrodermic, or guttate), other than plaque psoriasis or inverse psoriasis.
2. Subject has history of drug-induced psoriasis.
3. Subject has arthritis that requires systemic treatment.
4. Subject unable to avoid use of tanning booths for at least 4 weeks prior to baseline and during study.
5. Subject is currently enrolled in any other clinical trial involving an investigational product.
6. Other than psoriasis, subject has history of clinically significant or uncontrolled disease (as determined by the Investigator), including the presence of laboratory abnormalities, cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease, which places the subject at unacceptable risk if he/she were to participate in the study
7. Prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
8. Subjects with severe renal impairment, defined by estimated glomerular filtration rate (eGFR) or creatinine clearance (CLcr) less than 30 mL/min, are also categorized as having Stage 4 chronic kidney disease (CKD), and are excluded from the study.
9. Malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas.
10. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to Screening and no new or recurrent infections prior to the Baseline Visit.
11. Subject has received a live vaccine within 3 months of baseline or plans to do so during study.
12. Subject is a pregnant or breastfeeding (lactating) woman.
13. Subject has used topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, anthralin/dithranol, or moisturizers which contain urea or salicylic acid). Use of phototherapy within 4 weeks prior to randomization. Use of conventional systemic therapy or systemic corticosteroids within 4 weeks prior to randomization, except for conditions other than psoriasis or psoriatic arthritis. Use of biologic therapy within 5 pharmacokinetic half-lives.
14. Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
15. Subject has any condition that confounds the ability to interpret data from the study.
16. Subject has history of allergy or hypersensitivity to any components of the IP (including placebo).
17. Subject has rare hereditary problem of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.
18. Subject's most severe manifestation corresponds to a manifestation whose randomization block has already been fully enrolled.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Bordeaux, , France
Research Site
Grenoble, , France
Research Site
Lyon, , France
Research Site
Paris, , France
Research Site
Pringy, , France
Research Site
Rouen, , France
Research Site
Saint-Priest-en-Jarez, , France
Research Site
Toulouse, , France
Research Site
Valence, , France
Research Site
Valenciennes, , France
Research Site
Aachen, , Germany
Research Site
Augsburg, , Germany
Research Site
Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Bochum, , Germany
Research Site
Bonn, , Germany
Research Site
Erlangen, , Germany
Research Site
Frankfurt am Main, , Germany
Research Site
Gera, , Germany
Research Site
Hamburg, , Germany
Research Site
Heidelberg, , Germany
Research Site
Jena, , Germany
Research Site
Kiel, , Germany
Research Site
Langenau, , Germany
Research Site
Lübeck, , Germany
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Marburg, , Germany
Research Site
München, , Germany
Research Site
Tübingen, , Germany
Research Site
Ulm, , Germany
Research Site
Bologna, , Italy
Research Site
Catania, , Italy
Research Site
Genova, , Italy
Research Site
Milan, , Italy
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Napoli, , Italy
Research Site
Napoli, Campania, , Italy
Research Site
Perugia, , Italy
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Roma, , Italy
Research Site
Roma, , Italy
Research Site
Badalona, Catalonia, Spain
Research Site
Alcorcón, Madrid, Spain
Research Site
Fuenlabrada, Madrid, Spain
Research Site
Alicante, Valencia, Spain
Research Site
Manises, Valencia, Spain
Research Site
Castellon, , Spain
Research Site
Lugo, , Spain
Research Site
Madrid, , Spain
Research Site
Murcia, , Spain
Research Site
Salamanca, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Seville, , Spain
Research Site
Seville, , Spain
Research Site
Lausanne, , Switzerland
Research Site
Zurich, , Switzerland
Research Site
Barnet, , United Kingdom
Research Site
Birmingham, , United Kingdom
Research Site
Brighton, , United Kingdom
Research Site
Bury St Edmunds, , United Kingdom
Research Site
Dumfries, , United Kingdom
Research Site
Dundee, , United Kingdom
Research Site
Exeter, , United Kingdom
Research Site
Gloucester, , United Kingdom
Research Site
Isleworth, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Newport, , United Kingdom
Research Site
Nottingham, , United Kingdom
Research Site
Plymouth, , United Kingdom
Research Site
Redhill, , United Kingdom
Research Site
Southampton, , United Kingdom
Research Site
Stourbridge, , United Kingdom
Countries
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References
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Mrowietz U, Barker J, Conrad C, Jullien D, Gisondi P, Flower A, Reddy J, Paris M, Picard H, Jardon S, Augustin M. Efficacy and safety of apremilast in patients with limited skin involvement, plaque psoriasis in special areas and impaired quality of life: Results from the EMBRACE randomized trial. J Eur Acad Dermatol Venereol. 2023 Feb;37(2):348-355. doi: 10.1111/jdv.18689. Epub 2022 Nov 14.
Augustin M, Barker J, Conrad C, Jullien D, Carrascosa JM, Reddy J, Amouzadeh H, Colgan S, Zou H, Mrowietz U. Efficacy and Safety of Apremilast Over 52 Weeks in Patients with Plaque Psoriasis in High-Impact Areas and Impaired Quality of Life. Dermatol Ther (Heidelb). 2025 Jul;15(7):1915-1929. doi: 10.1007/s13555-025-01389-z. Epub 2025 May 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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U1111-1224-8381
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-002850-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-10004-PSOR-020
Identifier Type: -
Identifier Source: org_study_id
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