A clinical study is designed to evaluate the efficacy and safety of apremilast (CC-10004) in patients with moderate to severe genital psoriasis
- Conditions
- MODERATE TO SEVERE GENITAL PSORIASISMedDRA version: 20.0 Level: LLT Classification code 10063407 Term: Psoriasis genital System Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-002608-15-FR
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 332
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 must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
5. Subject must have a diagnosis of moderate or severe psoriasis of the genital area at Screening and Baseline as defined by having a modified sPGA-G score of = 3 (moderate or severe).
6. Subject must have a diagnosis of moderate or severe psoriasis at Screening and Baseline as defined by having a sPGA score of = 3.
7. Subject must have plaque psoriasis (BSA = 1%) in a non-genital area at both Screening and Baseline.
8. Subject must have been inadequately controlled with or intolerant of topical therapy, or topical therapy is inappropriate for the treatment of psoriasis affecting the genital area.
9. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
10. Subject must meet the following laboratory criteria:
a. White blood cell count = 3000/mm3 (= 3.0 x 109/L) and < 14,000/mm3(< 14 x 109/L)
b. Platelet count = 100,000/µL (= 100 x 109/L)
c. Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L)
d. Total bilirubin = 2 mg/dL (=34 µmol/L)
e. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) = 2 x upper limit of normal (ULN)
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 332
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
The presence of any of the following will exclude a subject from enrollment:
1. Subject has any significant medical condition or laboratory abnormality, that would prevent the subject from participating in the study.
2. 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.
3. Subject has any condition that confounds the ability to interpret data from the study.
4. Subject is pregnant or breast feeding.
5. Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at Screening.
6. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
7. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
8. Subject has active substance abuse or a history of substance abuse within 6 months prior to Screening.
9. Subject has 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 at least 4 weeks prior to Screening.
10. Subject has malignancy or history of malignancy (except for treated [i.e. cured] basal cell or squamous cell in situ skin carcinomas and treated [i.e. cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence).
11. Subject has 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.
12. Subject has psoriasis flare/rebound (defined as a sudden worsening of body psoriasis or psoriasis of the genitalia which requires administration of prohibited medications) within 4 weeks of Screening or between the Screening and Baseline Visit.
13. Subject has current or planned concurrent use of the following therapies that may have a possible effect on psoriasis of the body and/or genital area during the course of the treatment phase of the trial:
a. Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, vitamin D analog preparations, calcineurin inhibitors).
-Exceptions: unmedicated emollients (eg, Eucerin®) for body lesions and non-medicated shampoos for scalp lesions (Subjects should not use these topical treatments within 24 hours prior
to the clinic visit.)
b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, fumaric acid esters).
c. Phototherapy treatment of body within 4 weeks prior to randomization (i.e. ultraviolet B [UVB], psoralen and ultraviolet A radiation [PUVA]).
d. Biologic therapy:
i. TNF or IL-17 blockers such as adalimumab, brodalumab, certolizumab pegol, etanercept, infliximab,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method