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
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast; Placebo
Intervention description: Apremilast 30 mg tablets taken orally twice a day.; Placebo tablets taken orally twice a day
Intervention MeSH terms: Apremilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Apremilast; CC-10004; Quality of life; Safety; Efficacy; Psoriasis manifestations

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.
    

Eligibility 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.