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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)

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ClinicalTrials.gov Identifier: NCT03774875
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : June 19, 2020
Estimated Study Completion Date : February 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 Itch NRS score [ Time Frame: Week 16, 32 and 52 ]
    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)

  10. Treatment-emergent Adverse events [ Time Frame: From enrollment until at least 28 days after completion of study treatment, an average of 1 year. ]
    Frequency and incidence rate of any TEAE by SOC, PT, severity, and relationship of adverse events (AEs) to investigational product (IP)

  11. Clinically significant changes in body weight [ Time Frame: Throughout the duration of the apremilast treatment, an average of 1 year. ]
    Frequency of clinically significant changes in body weight.

  12. Clinically significant changes in waist circumference [ Time Frame: Throughout the duration of the apremilast treatment, an average of 1 year. ]
    Frequency of clinically significant changes in waist circumference.

  13. Clinically significant changes in vital signs [ Time Frame: Throughout the duration of the apremilast treatment, an average of 1 year. ]
    Frequency of clinically significant changes in vital signs.

  14. Clinically significant changes in laboratory findings [ Time Frame: Throughout the duration of the apremilast treatment, an average of 1 year. ]
    Frequency of clinically significant changes in laboratory findings.



Information from the National Library of Medicine

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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: DO NOT USE ACROYNMS

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 eGFR (estimated glomerular filtration rate) or CLcr (creatinine clearance) 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. (NOTE: This will allow to block-randomize equally to each of the manifestations of plaque psoriasis specified in Inclusion Criteria #7. An alert from IRT (interactive response technology) system will notify Investigators of the recruitment status of each of the manifestation randomization blocks

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


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Show 74 Study Locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Priscila Nakasato, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov 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: June 12, 2019
Last Verified: June 2019

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

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
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
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents