PsoriasisPhase 4EMBRACENCT03774875
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
A Phase 4 study testing Apremilast in people with Psoriasis, run by Amgen at 72 sites in 6 countries.
Trial 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. 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
- 277 participants
- Where
- 72 sitesin 6 countries
- Study dates
- 28 Mar 2019to 3 Nov 2021
- Phase
- Phase 4
- 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:
- 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.
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- 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.)
- 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.
- 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.
- 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.
Who cannot join
- 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.
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- 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.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject has history of allergy or hypersensitivity to any components of the IP (including placebo).
- Subject has rare hereditary problem of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.
- Subject's most severe manifestation corresponds to a manifestation whose randomization block has already been fully enrolled.
Trial locations and contacts
72 sites in 6 countries.
72 sites in 6 countries
Germany21 sites
Research Site
Aachen, 52074
Research Site
Augsburg, 86179
Research Site
Berlin, 10117
Research Site
Berlin, 10247
Research Site
Berlin, 13086
Research Site
Berlin, 13507
Research Site
Bochum, 44803
Research Site
Bonn, 53111
Research Site
Erlangen, 91054
Research Site
Frankfurt am Main, 60590
Research Site
Gera, 07548
Research Site
Hamburg, 20246
Research Site
Heidelberg, 69115
Research Site
Jena, 07743
Research Site
Kiel, 24105
Research Site
Langenau, 89129
Research Site
Lübeck, 23538
Research Site
Marburg, 35043
Research Site
München, 80802
Research Site
Tübingen, 72076
Research Site
Ulm, 89081
United Kingdom17 sites
Research Site
Barnet, EN5 3DJ
Research Site
Birmingham, B15 2WB
Research Site
Brighton, BN2 3EW
Research Site
Bury St Edmunds, IP33 2QZ
Research Site
Dumfries, DG1 4AP
Research Site
Dundee, DD1 9SY
Research Site
Exeter, EX2 5DW
Research Site
Gloucester, GL1 3NN
Research Site
Isleworth, TW7 6AF
Research Site
Leeds, LS7 4SA
Research Site
London, SE1 9RT
Research Site
Newport, NP18 3XQ
Research Site
Nottingham, NG7 2UH
Research Site
Plymouth, PL6 8DH
Research Site
Redhill, RH1 5RH
Research Site
Southampton, SO16 6YD
Research Site
Stourbridge, DY8 4JB
Spain13 sites
Research Site
Alcorcón, Madrid, 28922
Research Site
Alicante, Valencia, 03010
Research Site
Badalona, Catalonia, 08916
Research Site
Castellon, 12004
Research Site
Fuenlabrada, Madrid, 28942
Research Site
Lugo, 27003
Research Site
Madrid, 28040
Research Site
Manises, Valencia, 46940
Research Site
Murcia, 30008
Research Site
Salamanca, 37007
Research Site
Santiago de Compostela, 15706
Research Site
Seville, 41013
Research Site
Seville, 41014
France10 sites
Research Site
Bordeaux, 33075
Research Site
Grenoble, 38043
Research Site
Lyon, 69437
Research Site
Paris, 75475
Research Site
Pringy, 74374
Research Site
Rouen, 76031
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Toulouse, 31059
Research Site
Valence, 26953
Research Site
Valenciennes, 72037
Italy9 sites
Research Site
Bologna, 40138
Research Site
Catania, 95123
Research Site
Genova, 16132
Research Site
Milan, 20122
Research Site
Naples, 80138
Research Site
Napoli, Campania, 80131
Research Site
Perugia, 06129
Research Site
Roma, 00133
Research Site
Roma, 00168
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Apremilast, Placebo
- Keywords
- Apremilast, CC-10004, Quality of life, Safety, Efficacy, Psoriasis manifestations
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Otezla, CC-10004
Apremilast 30 mg tablets taken orally twice a day.
PlaceboDrug
Placebo tablets taken orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| Apremilast 30 mg | Experimental | Participants will take apremilast 30 mg tablets orally twice a day for up to 52 weeks. Receives: 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. Receives: Drug: Apremilast; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 16
Secondary outcomes (37)
Change From Baseline in 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. 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.
Measured: Baseline and week 16
Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at 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.
Measured: Baseline and week 16
Change From Baseline in Itch Numeric Rating Scale (NRS) Score at 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.
Measured: Baseline and week 16
Change From Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at 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.
Measured: Baseline and week 16
Percentage of Participants Who Achieved a Psoriasis Area Severity Index (PASI) Score < 3 at 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.
Measured: Week 16
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at 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).
Measured: Week 16
Percent Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) VAS Score at 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.
Measured: Baseline and week 16
Percent Change From Baseline in EQ-5D Index Score at 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.
Measured: Baseline and week 16
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) at Week 16: Percentage Work Time Missed
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.
Measured: Baseline and week 16
Change From Baseline in WPAI: PSO at Week 16: Percentage Work Impairment
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.
Measured: Baseline and week 16
Change From Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment
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.
Measured: Baseline and week 16
Change From Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment
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.
Measured: Baseline and week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled 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.
Measured: 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
Marked laboratory abnormalities are defined for each parameter below.
ULN = upper limit of normal
Measured: 16 weeks
Change From Baseline in Blood Pressure During the Placebo-controlled Period
Measured: Baseline, week 2, week 4, and week 16
Change From Baseline in Pulse Rate During the Placebo-controlled Period
Measured: Baseline and week 2, week 4, and week 16
Change From Baseline in Body Weight During the Placebo-controlled Period
Measured: Baseline and week 2, week 4, and week 16
Change From Baseline in Waist Circumference During the Placebo-controlled Period
Measured: 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
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.
Measured: Baseline, week 32 and week 52
Change From Baseline in DLQI at Weeks 32 and 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.
Measured: Baseline, week 32 and week 52
Change From Baseline in Itch NRS Score at Weeks 32 and 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.
Measured: Baseline, week 32 and week 52
Change From Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 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.
Measured: Baseline, week 32 and week 52
Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 32 and 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.
Measured: Baseline, week 32 and week 52
Percentage of Participants Who Achieved a PBI Score of ≥ 1 at Weeks 32 and 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).
Measured: Week 32 and week 52
Percentage of Participants Who Achieved a PASI Score < 3 at Weeks 32 and 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.
Measured: Week 32 and week 52
Percent Change From Baseline in EQ-5D VAS Score at 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.
Measured: Baseline and week 52
Percent Change From Baseline in EQ-5D Index Score at 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.
Measured: Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed
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.
Measured: Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Work Impairment
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.
Measured: Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment
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.
Measured: Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment
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.
Measured: Baseline and week 52
Number of Participants With TEAEs During Apremilast Treatment
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start28 Mar 2019
- Primary completion1 Feb 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774875
- Sponsor's protocol ID
- CC-10004-PSOR-020
- Other IDs
- U1111-1224-8381, 2018-002850-58, 2018
- Acronym
- EMBRACE
- Status last verified
- Jul 2025
- First submitted
- 11 Dec 2018
- Last updated
- 10 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Publications
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.
PubMed 36300769Augustin 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.
PubMed 40317400Strober 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03774875
- Acronym / sponsor ID
- EMBRACE / CC-10004-PSOR-020
- Conditions
- Psoriasis
- Keywords
- Apremilast, CC-10004, Quality of life, Safety, Efficacy, Psoriasis manifestations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Posted 13 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast 30 mg | Experimental | Drug: ApremilastParticipants will take apremilast 30 mg tablets orally twice a day for up to 52 weeks. |
| Placebo / Apremilast 30 mg | Placebo comparator | Drug: Apremilast, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastAlso: Otezla, CC-10004Apremilast 30 mg tablets taken orally twice a day. | Drug | Apremilast 30 mg, Placebo / Apremilast 30 mg |
| PlaceboPlacebo tablets taken orally twice a day | Drug | Placebo / Apremilast 30 mg |
Primary outcome
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.
37 secondary outcomes
Change From Baseline in DLQI at Week 16
Time frame: 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
Change From Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16
Time frame: Baseline and week 16
Change From Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16
Time frame: Baseline and week 16
Percentage of Participants Who Achieved a Psoriasis Area Severity Index (PASI) Score < 3 at Week 16
Time frame: Week 16
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at Week 16
Time frame: 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
Percent Change From Baseline in EQ-5D Index Score at Week 16
Time frame: 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
Change From Baseline in WPAI: PSO at Week 16: Percentage Work Impairment
Time frame: Baseline and week 16
Change From Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment
Time frame: Baseline and week 16
Change From Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment
Time frame: 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.
Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period
Time frame: 16 weeks
Change From Baseline in Blood Pressure During the Placebo-controlled Period
Time frame: 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
Change From Baseline in Body Weight During the Placebo-controlled Period
Time frame: 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
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
Change From Baseline in DLQI at Weeks 32 and 52
Time frame: 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
Change From Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52
Time frame: 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
Percentage of Participants Who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52
Time frame: 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
Percent Change From Baseline in EQ-5D VAS Score at Week 52
Time frame: Baseline and week 52
Percent Change From Baseline in EQ-5D Index Score at Week 52
Time frame: Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed
Time frame: Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Work Impairment
Time frame: Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment
Time frame: Baseline and week 52
Change From Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment
Time frame: 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.
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.
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36300769Mrowietz 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.
- Background: PubMed 40317400Augustin 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.
- Derived from this study: PubMed 42825996Strober 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
72 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apremilast in people with Psoriasis, run by Amgen at 72 sites in 6 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 20 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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in Germany, United Kingdom, Spain, France, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2022). 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 Who Achieved a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 (time frame: Baseline and 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 NCT03774875, 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 10 Jul 2025.