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 (EMBRACE)

July 1, 2025 updated by: Amgen

A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will be randomized 2 (apremilast):1 (placebo) in approximately 10 countries in Western Europe. Participants will be block-randomized to each of the manifestations of psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and psoriasis in visible locations). Participants presenting with multiple manifestations will be allocated to the manifestation which is most severe, as determined by the participant. All manifestations will be assessed for efficacy at each study visit.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
277

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33075
        • Research Site
      • Grenoble Cedex 9, France, 38043
        • Research Site
      • Lyon Cedex 03, France, 69437
        • Research Site
      • Paris Cedex 10, France, 75475
        • Research Site
      • Pringy, France, 74374
        • Research Site
      • Rouen Cedex, France, 76031
        • Research Site
      • Saint Priest en Jarez, France, 42270
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
      • Valence, France, 26953
        • Research Site
      • Valenciennes, France, 72037
        • Research Site
  • Germany
      • Aachen, Germany, 52074
        • Research Site
      • Augsburg, Germany, 86179
        • Research Site
      • Berlin, Germany, 10117
        • Research Site
      • Berlin, Germany, 10247
        • Research Site
      • Berlin, Germany, 13086
        • Research Site
      • Berlin, Germany, 13507
        • Research Site
      • Bochum, Germany, 44803
        • Research Site
      • Bonn, Germany, 53111
        • Research Site
      • Erlangen, Germany, 91054
        • Research Site
      • Frankfurt am Main, Germany, 60590
        • Research Site
      • Gera, Germany, 07548
        • Research Site
      • Hamburg, Germany, 20246
        • Research Site
      • Heidelberg, Germany, 69115
        • Research Site
      • Jena, Germany, 07743
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
      • Langenau, Germany, 89129
        • Research Site
      • Lübeck, Germany, 23538
        • Research Site
      • Marburg, Germany, 35043
        • Research Site
      • München, Germany, 80802
        • Research Site
      • Tübingen, Germany, 72076
        • Research Site
      • Ulm, Germany, 89081
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Research Site
      • Catania, Italy, 95123
        • Research Site
      • Genova, Italy, 16132
        • Research Site
      • Milano, Italy, 20122
        • Research Site
      • Napoli, Italy, 80138
        • Research Site
      • Napoli, Campania, Italy, 80131
        • Research Site
      • Perugia, Italy, 06129
        • Research Site
      • Roma, Italy, 00168
        • Research Site
      • Roma, Italy, 00133
        • Research Site
  • Spain
      • Castellon de la Plana, Spain, 12004
        • Research Site
      • Lugo, Spain, 27003
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Murcia, Spain, 30008
        • Research Site
      • Salamanca, Spain, 37007
        • Research Site
      • Santiago de Compostela, Spain, 15706
        • Research Site
      • Sevilla, Spain, 41013
        • Research Site
      • Sevilla, Spain, 41014
        • Research Site
    • Cataluña
      • Badalona, Cataluña, Spain, 08916
        • Research Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03010
        • Research Site
      • Manises, Comunidad Valenciana, Spain, 46940
        • Research Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Research Site
      • Fuenlabrada, Madrid, Spain, 28942
        • Research Site
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Research Site
      • Zurich, Switzerland, 8091
        • Research Site
      • Zürich, Switzerland, 8091
        • Research Site
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Research Site
      • Birmingham, United Kingdom, B15 2WB
        • Research Site
      • Brighton, United Kingdom, BN2 3EW
        • Research Site
      • Bury Saint Edmunds, United Kingdom, IP33 2QZ
        • Research Site
      • Dumfries, United Kingdom, DG1 4AP
        • Research Site
      • Dundee, United Kingdom, DD1 9SY
        • Research Site
      • Exeter, United Kingdom, EX2 5DW
        • Research Site
      • Gloucester, United Kingdom, GL1 3NN
        • Research Site
      • Isleworth, United Kingdom, TW7 6AF
        • Research Site
      • Leeds, United Kingdom, LS7 4SA
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Research Site
      • Newport, United Kingdom, NP18 3XQ
        • Research Site
      • Nottingham, United Kingdom, NG7 2UH
        • Research Site
      • Plymouth, United Kingdom, PL6 8DH
        • Research Site
      • Redhill, United Kingdom, RH1 5RH
        • Research Site
      • Southampton, United Kingdom, SO16 6YD
        • Research Site
      • Stourbridge, United Kingdom, DY8 4JB
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  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:

The presence of any of the following will exclude a subject from enrollment:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Apremilast 30 mg
Participants will take apremilast 30 mg tablets orally twice a day for up to 52 weeks.
Drug: Apremilast
Apremilast 30 mg tablets taken orally twice a day.
Other Names:
  • CC-10004
  • Otezla
Placebo Comparator: 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.
Drug: Apremilast
Apremilast 30 mg tablets taken orally twice a day.
Other Names:
  • CC-10004
  • Otezla
Drug: Placebo
Placebo tablets taken orally twice a day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Time Frame: Baseline and 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in DLQI at Week 16
Time Frame: Baseline and 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. 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. A negative change from baseline indicates improvement in quality of life.
Baseline and week 16
Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16
Time Frame: Baseline and week 16
Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.
Baseline and week 16
Change From Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16
Time Frame: Baseline and week 16

The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.

A negative change from baseline indicates improvement in itch severity.
Baseline and week 16
Change From Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16
Time Frame: Baseline and week 16

Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.

A negative change from baseline indicates improvement in skin discomfort/pain.
Baseline and week 16
Percentage of Participants Who Achieved a Psoriasis Area Severity Index (PASI) Score < 3 at Week 16
Time Frame: Week 16
The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Week 16
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at Week 16
Time Frame: Week 16
The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (16 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).
Week 16
Percent Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) VAS Score at Week 16
Time Frame: Baseline and week 16
EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.
Baseline and week 16
Percent Change From Baseline in EQ-5D Index Score at Week 16
Time Frame: Baseline and week 16

EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.

EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.
Baseline and week 16
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) at Week 16: Percentage Work Time Missed
Time Frame: Baseline and week 16
The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.
Baseline and week 16
Change From Baseline in WPAI: PSO at Week 16: Percentage Work Impairment
Time Frame: Baseline and week 16
The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
Baseline and week 16
Change From Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment
Time Frame: Baseline and week 16
The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
Baseline and week 16
Change From Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment
Time Frame: Baseline and week 16
The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
Baseline and week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period
Time Frame: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period.

An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.

A serious adverse event (SAE) is any AE occurring at any dose that:

  • Resulted in death;
  • Was life-threatening;
  • Required inpatient hospitalization or prolongation of existing hospitalization;
  • Resulted in persistent or significant disability/incapacity;
  • Was a congenital anomaly/birth defect;
  • Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.
From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period.
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period
Time Frame: 16 weeks

Marked laboratory abnormalities are defined for each parameter below.

ULN = upper limit of normal
16 weeks
Change From Baseline in Blood Pressure During the Placebo-controlled Period
Time Frame: Baseline, week 2, week 4, and week 16
Baseline, week 2, week 4, and week 16
Change From Baseline in Pulse Rate During the Placebo-controlled Period
Time Frame: Baseline and week 2, week 4, and week 16
Baseline and week 2, week 4, and week 16
Change From Baseline in Body Weight During the Placebo-controlled Period
Time Frame: Baseline and week 2, week 4, and week 16
Baseline and week 2, week 4, and week 16
Change From Baseline in Waist Circumference During the Placebo-controlled Period
Time Frame: Baseline and week 2, week 4, and week 16
Baseline and week 2, week 4, and week 16
Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in DLQI at Weeks 32 and 52
Time Frame: Baseline, week 32 and week 52
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, week 32 and week 52
Change From Baseline in DLQI at Weeks 32 and 52
Time Frame: Baseline, week 32 and week 52
The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. 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. A negative change from baseline indicates improvement in quality of life.
Baseline, week 32 and week 52
Change From Baseline in Itch NRS Score at Weeks 32 and 52
Time Frame: Baseline, week 32 and week 52

The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.

A negative change from baseline indicates improvement in itch severity.
Baseline, week 32 and week 52
Change From Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52
Time Frame: Baseline, week 32 and week 52

Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.

A negative change from baseline indicates improvement in skin discomfort/pain.
Baseline, week 32 and week 52
Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 32 and 52
Time Frame: Baseline, week 32 and week 52
Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.
Baseline, week 32 and week 52
Percentage of Participants Who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52
Time Frame: Week 32 and week 52
The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (32 weeks and 52 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).
Week 32 and week 52
Percentage of Participants Who Achieved a PASI Score < 3 at Weeks 32 and 52
Time Frame: Week 32 and week 52
The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Week 32 and week 52
Percent Change From Baseline in EQ-5D VAS Score at Week 52
Time Frame: Baseline and week 52
EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.
Baseline and week 52
Percent Change From Baseline in EQ-5D Index Score at Week 52
Time Frame: Baseline and week 52

EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.

EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.
Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed
Time Frame: Baseline and week 52
The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.
Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Work Impairment
Time Frame: Baseline and week 52
The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment
Time Frame: Baseline and week 52
The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment
Time Frame: Baseline and week 52
The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
Baseline and week 52
Number of Participants With TEAEs During Apremilast Treatment
Time Frame: From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.

A serious adverse event (SAE) is any AE occurring at any dose that:

  • Resulted in death;
  • Was life-threatening;
  • Required inpatient hospitalization or prolongation of existing hospitalization;
  • Resulted in persistent or significant disability/incapacity;
  • Was a congenital anomaly/birth defect;
  • Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.
From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.
Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment
Time Frame: From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.
From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.
Change From Baseline in Blood Pressure at End of Apremilast Extension Period
Time Frame: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
Change From Baseline in Pulse Rate at End of Apremilast Extension Period
Time Frame: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
Change From Baseline in Body Weight at End of Apremilast Extension Period
Time Frame: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
Change From Baseline in Waist Circumference at End of Apremilast Extension Period
Time Frame: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-10004-PSOR-020
  • U1111-1224-8381 (Registry Identifier: WHO)
  • 2018-002850-58 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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