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

NCT03774875 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: CC-10004-PSOR-020U1111-1224-83812018-002850-58
• Study Type: interventional
• Target: 277
• Locations: 6 countries
• Sites: 72

Brief Summary

The primary objective of the study is to assess the impact of treatment with apremilast 30 mg twice daily for 16 weeks, compared to placebo, on health-related quality of life (QOL) in adults with manifestations of plaque psoriasis and impaired quality of life.

Conditions

Psoriasis

Keywords

Apremilast; CC-10004; Quality of life; Safety; Efficacy; Psoriasis manifestations

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

  The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.

  Baseline and week 16

Secondary Outcomes (37)

• Change From Baseline in DLQI at Week 16

  Baseline and week 16

• Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16

  Baseline and week 16

• Change From Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16

  Baseline and week 16

• Change From Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16

  Baseline and week 16

• Percentage of Participants Who Achieved a Psoriasis Area Severity Index (PASI) Score < 3 at Week 16

  Week 16

Study Arms (2)

Apremilast 30 mg

EXPERIMENTAL

Participants will take apremilast 30 mg tablets orally twice a day for up to 52 weeks.

Drug: Apremilast

Placebo / Apremilast 30 mg

PLACEBO COMPARATOR

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.

Drug: Apremilast; Drug: Placebo

Interventions

Apremilast DRUG

Apremilast 30 mg tablets taken orally twice a day.

Also known as: Otezla, CC-10004

Apremilast 30 mg; Placebo / Apremilast 30 mg

Placebo DRUG

Placebo tablets taken orally twice a day

Placebo / Apremilast 30 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Subject has diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline, that cannot be controlled by topical therapy.
• Subject has a PASI score ranging from ≥ 3 to ≤ 10 at baseline.
• Subject has a DLQI score \> 10 at baseline.
• Subject has presence of ≥ 1 clinical manifestations of plaque psoriasis, defined as at least one of the following:
• Moderate to severe scalp psoriasis, defined as Scalp Physician Global Assessment (ScPGA) ≥ 3
• Nail psoriasis, defined as onycholysis and onychodystrophy in at least 2 fingernails
• Moderate to severe genital plaque psoriasis, defined as modified static Physicians Global Assessment of Genitalia (sPGA-G) ≥ 3
• Moderate to severe palmoplantar psoriasis, defined as Palmoplantar Psoriasis Physicians Global Assessment (PPPGA) ≥ 3
• Moderate to severe plaque psoriasis in visible locations (dorsal hand, face, neck, and hairline) with static Physicians Global Assessment (sPGA) ≥ 3
• 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.)

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• 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.
• Subject has history of drug-induced psoriasis.
• Subject has arthritis that requires systemic treatment.
• Subject unable to avoid use of tanning booths for at least 4 weeks prior to baseline and during study.
• Subject is currently enrolled in any other clinical trial involving an investigational product.
• 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
• 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.
• 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.
• 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.
• 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.
• Subject has received a live vaccine within 3 months of baseline or plans to do so during study.
• Subject is a pregnant or breastfeeding (lactating) woman.
• 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.
• Prior treatment with apremilast, or participation in a clinical study, involving apremilast.

Sponsors & Collaborators

• Amgen: lead

Study Sites (72)

Research Site

Bordeaux, 33075, France

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Grenoble, 38043, France

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Lyon, 69437, France

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Paris, 75475, France

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Pringy, 74374, France

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Rouen, 76031, France

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Saint-Priest-en-Jarez, 42270, France

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Toulouse, 31059, France

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Valence, 26953, France

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Valenciennes, 72037, France

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Aachen, 52074, Germany

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Augsburg, 86179, Germany

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Berlin, 10117, Germany

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Berlin, 10247, Germany

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Berlin, 13086, Germany

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Berlin, 13507, Germany

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Bochum, 44803, Germany

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Bonn, 53111, Germany

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Erlangen, 91054, Germany

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Frankfurt am Main, 60590, Germany

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Gera, 07548, Germany

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Hamburg, 20246, Germany

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Heidelberg, 69115, Germany

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Jena, 07743, Germany

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Kiel, 24105, Germany

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Langenau, 89129, Germany

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Lübeck, 23538, Germany

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Marburg, 35043, Germany

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München, 80802, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Bologna, 40138, Italy

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Catania, 95123, Italy

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Genova, 16132, Italy

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Milan, 20122, Italy

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Napoli, 80138, Italy

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Napoli, Campania, 80131, Italy

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Perugia, 06129, Italy

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Roma, 00133, Italy

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Roma, 00168, Italy

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Badalona, Catalonia, 08916, Spain

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Alcorcón, Madrid, 28922, Spain

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Fuenlabrada, Madrid, 28942, Spain

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Alicante, Valencia, 03010, Spain

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Manises, Valencia, 46940, Spain

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Castellon, 12004, Spain

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Lugo, 27003, Spain

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Madrid, 28040, Spain

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Murcia, 30008, Spain

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Salamanca, 37007, Spain

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Santiago de Compostela, 15706, Spain

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Seville, 41013, Spain

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Seville, 41014, Spain

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Lausanne, 1011, Switzerland

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Zurich, 8091, Switzerland

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Barnet, EN5 3DJ, United Kingdom

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Birmingham, B15 2WB, United Kingdom

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Brighton, BN2 3EW, United Kingdom

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Bury St Edmunds, IP33 2QZ, United Kingdom

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Dumfries, DG1 4AP, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Exeter, EX2 5DW, United Kingdom

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Gloucester, GL1 3NN, United Kingdom

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Isleworth, TW7 6AF, United Kingdom

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Leeds, LS7 4SA, United Kingdom

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London, SE1 9RT, United Kingdom

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Newport, NP18 3XQ, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Redhill, RH1 5RH, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Stourbridge, DY8 4JB, United Kingdom

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Related Publications (2)

• 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.

  PMID: 36300769 BACKGROUND

• 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.

  PMID: 40317400 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: March 28, 2019
• Primary Completion: February 1, 2021
• Study Completion: November 3, 2021
• Last Updated: July 10, 2025
• Results First Posted: January 13, 2022

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CH (2); FR (10); ES (13); GB (17); DE (21); IT (9)