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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774875
Recruitment Status : Completed
First Posted : December 13, 2018
Results First Posted : January 13, 2022
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Apremilast Drug: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 28, 2019
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : November 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Arm Intervention/treatment
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:
  • Otezla
  • CC-10004

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:
  • Otezla
  • CC-10004

Drug: Placebo
Placebo tablets taken orally twice a day




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.


  5. 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.

  6. 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).

  7. 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.

  8. 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.


  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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


  15. Change From Baseline in Blood Pressure During the Placebo-controlled Period [ Time Frame: Baseline, week 2, week 4, and week 16 ]
  16. Change From Baseline in Pulse Rate During the Placebo-controlled Period [ Time Frame: Baseline and week 2, week 4, and week 16 ]
  17. Change From Baseline in Body Weight During the Placebo-controlled Period [ Time Frame: Baseline and week 2, week 4, and week 16 ]
  18. Change From Baseline in Waist Circumference During the Placebo-controlled Period [ Time Frame: Baseline and week 2, week 4, and week 16 ]
  19. 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.

  20. 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.

  21. 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.


  22. 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.


  23. 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.

  24. 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).

  25. 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.

  26. 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.

  27. 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.


  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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. ]
  34. 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 ]
  35. 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 ]
  36. 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 ]
  37. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774875


Locations
Show Show 73 study locations
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] May 1, 2020
Statistical Analysis Plan  [PDF] February 10, 2021

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03774875    
Other Study ID Numbers: CC-10004-PSOR-020
U1111-1224-8381 ( Registry Identifier: WHO )
2018-002850-58 ( EudraCT Number )
First Posted: December 13, 2018    Key Record Dates
Results First Posted: January 13, 2022
Last Update Posted: September 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Apremilast
CC-10004
Quality of life
Safety
Efficacy
Psoriasis manifestations
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action