A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast; Placebo
Intervention description: Apremilast 30 mg tablets BID from weeks 0 to 32.; Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
Intervention MeSH terms: Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque Psoriasis; Scalp; Double-Blind; Efficacy; Safety; CC-10004; Apremilast; Otezla; Itch; Head

Summary:

      This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the
      efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque
      psoriasis of the scalp.

      Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be
      randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first
      16 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must satisfy the following criteria to be enrolled in the study:

          -  Males or females, ≥ 18 years of age at the time of signing the informed consent
             document

          -  Be willing and able to adhere to the study visit schedule and other protocol
             requirements.

          -  Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening and
             baseline

          -  Must be a candidate for phototherapy and/or systemic therapy for either body or scalp
             psoriasis lesions.

          -  Have moderate to severe plaque psoriasis at screening and baseline

          -  Must be in good health (except for psoriasis) as judged by the Investigator, based on
             medical history, physical examination, 12-lead electrocardiogram (ECG), clinical
             laboratories, and urinalysis

          -  Must meet laboratory criteria

          -  Females of childbearing potential (FCBP)* must have a negative pregnancy test at
             screening and baseline. While on investigational product (IP) 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.

        *A female of childbearing potential is a sexually mature female who 1) has not undergone a
        hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical
        removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive
        months (that is, has had menses at any time during the preceding 24 consecutive months).

        ** The female subject's chosen form of contraception must be effective by the time the
        female subject is randomized into the study (for example, hormonal contraception should be
        initiated at least 28 days before randomization).

        Exclusion Criteria:

        The presence of any of the following will exclude a subject from enrollment:

          -  Other than psoriasis, history of any clinically significant uncontrolled disease.

        Any condition, including the presence of laboratory abnormalities, which would place the
        subject at unacceptable risk if he/she were to participate in the study.

          -  Pregnant or breast feeding

          -  Hepatitis B surface antigen positive at screening

          -  Anti-hepatitis C antibody positive at screening

          -  Active tuberculosis (TB) or a history of incompletely treated TB

          -  Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening

          -  History of positive human immunodeficiency virus (HIV), or have congenital or acquired
             immunodeficiency (eg, common variable immunodeficiency disease)

          -  Active substance abuse or a history of substance abuse within 6 months prior to
             signing the informed consent form.

          -  Bacterial infections requiring treatment with oral or injectable antibiotics, or
             significant viral or fungal infections, within 4 weeks of signing the informed consent
             form.

          -  Malignancy or history of malignancy, except for treated (i.e., cured) basal cell or
             squamous cell in situ skin carcinomas or treated (i.e., cured) cervical
             intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of
             recurrence within 5 years of signing the informed consent.

          -  Prior history of suicide attempt at any time in the subject's life time prior to
             signing the informed consent and randomization, or major psychiatric illness requiring
             hospitalization within the last 3 years prior to signing the informed consent.

          -  Psoriasis flare/rebound within 4 weeks of signing the informed consent form or between
             the screening and baseline visits.

          -  Topical therapy within 2 weeks prior to randomization; Conventional systemic therapy
             for psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids on
             the scalp within 2 weeks prior to randomization; Phototherapy treatment of body or
             scalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between
             12 weeks to 24 weeks prior to randomization

          -  Use of any investigational drug beginning 4 weeks prior to randomization, or 5
             pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)

          -  Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light
             sources

          -  Prior treatment with apremilast

          -  History of allergy or hypersensitivity to any components of the Investigational
             product.