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A 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. (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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03774875
Recruitment Status : Not yet recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Information provided by (Responsible Party):

Brief Summary:

This is a Phase 4, multi-center, randomized, placebo-controlled, double-blind study of the impact of apremilast on quality of life, efficacy, and safety in subjects with manifestations of plaque psoriasis and impaired quality of life.

Approximately 255 subjects will be randomized 2 (apremilast):1 (placebo) in approximately 6 to 10 countries in Western Europe. Subjects will be block-randomized equally to each of the manifestations of psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and psoriasis in visible locations). If subjects present with multiple manifestations, they will be allocated to the manifestation which is most severe, as determined by the subject.

However, all manifestations will be assessed for efficacy at each study visit.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Apremilast (CC-10004) Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 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.
Estimated Study Start Date : February 10, 2019
Estimated Primary Completion Date : June 19, 2020
Estimated Study Completion Date : May 26, 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 twice daily
Subjects will take oral tablets of apremilast for up to 52 weeks (30 mg twice daily).
Drug: Apremilast (CC-10004)
This study will randomize subjects to either apremilast 30 mg BID or placebo comparator in a 2:1 ratio, respectively. Subjects randomized to apremilast will receive dose-titration for the initial 5 days. Apremilast subjects will receive "dummy" titration at wk 16 to maintain the blinding of the original treatment assignments. Investigational product (IP) will be dispensed in blinded dose cards until Week 20. Thereafter, IP will be dispensed in open-label bottles.
Other Name: Otezla

Placebo Comparator: Placebo followed by Apremilast 30mg twice daily
Subjects will take placebo for 16 weeks. After Week 16, subjects will be switched to receive apremilast (30 mg twice daily) until Week 52.
Other: Placebo
Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally twice daily for 16 weeks.

Drug: Apremilast (CC-10004)
Beginning at Week 16 and after a 5-day titration with apremilast, subjects initially randomized to placebo will be switched to receive apremilast 30 mg BID for 36 weeks (52 weeks total). Investigational product (IP) will be dispensed in blinded dose cards until Week 20. Thereafter, IP will be dispensed in open-label bottles

Primary Outcome Measures :
  1. Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline [ Time Frame: Week16 ]
    Dermatology Life Quality Index (DLQI)

Secondary Outcome Measures :
  1. Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline [ Time Frame: Week 32 and 52 ]
    Dermatology Life Quality Index (DLQI)

  2. Mean change from baseline in DLQI [ Time Frame: Week 16, 32 and 52 ]
    Dermatology Life Quality Index (DLQI)

  3. Mean change from baseline in Whole Body Itch NRS score [ Time Frame: Week 16, 32 and 52 ]
    Whole Body Itch Numeric Rating Scale (NRS)

  4. Mean change from baseline in skin discomfort/pain VAS [ Time Frame: Week 16, 32 and 52 ]
    Skin Discomfort/Pain Visual Analog Scale (VAS)

  5. Mean percent change in BSA affected by psoriasis [ Time Frame: Week 16, 32 and 52 ]
    Body Surface Area (BSA)

  6. Proportion of subjects who achieve PBI score of ≥ 1 [ Time Frame: Week 16, 32 and 52 ]
    Patient Benefit Index (PBI)

  7. Proportion of subjects who achieve PASI < 3 [ Time Frame: Week 16, 32 and 52 ]
    Psoriasis Area Severity Index (PASI)

  8. Mean percent change from baseline in EQ-5D score [ Time Frame: Week 16 and 52 ]
    European Quality of Life 5- Dimension (EQ-5D)

  9. Mean change in WPAI domain scores [ Time Frame: Week 16 and 52 ]
    Work Productivity and Activity Impairment Questionnaire (WPAI)

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.

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

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.
  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, be contraindicated to, or intolerant to other conventional systemic therapy (including, but not limited to, cyclosporine, methotrexate, acitretin, OR 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.

Exclusion Criteria:

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

  1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  2. 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.
  3. Subject has history of drug-induced psoriasis.
  4. Subject has arthritis that requires systemic treatment.
  5. Subject unable to avoid use of tanning booths for at least 4 weeks prior to baseline and during study.
  6. Subject is currently enrolled in any other clinical trial involving an investigational product.
  7. Other than psoriasis, subject has any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
  8. 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.
  9. 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..
  10. Subject has received a live vaccine within 3 months of baseline or plans to do so during study.
  11. Subject is a pregnant or breastfeeding (lactating) woman.
  12. 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.
  13. Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
  14. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  15. Subject has any condition that confounds the ability to interpret data from the study.

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 identifier (NCT number): NCT03774875

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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599

Sponsors and Collaborators
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Study Director: Priscila Nakasato, MD Celgene

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Responsible Party: Celgene Identifier: NCT03774875     History of Changes
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
Last Update Posted: December 13, 2018
Last Verified: December 2018

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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 Celgene:
Quality of life
Psoriasis manifestations

Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents