MODERATE TO SEVERE GENITAL PSORIASIS MedDRA version: 20.0 Level: LLT Classification code 10063407 Term: Psoriasis genital System Organ Class: 100000004858
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion 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 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 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 =65 years) yes F.1.3.1 Number of subjects fo
Exclusion criteria
Exclusion criteria: 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 and genital 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, ixekizumab, secukinumab (or biosimilars for each) within 12 weeks prior to randomization ii. Anti-IL-12 or anti-IL-23 monoclonal antibodies such as ustekinumab, guselkumab, or tildrakizumab, within 24 weeks prior to randomization e. Use of any investigational drug beginning 4 weeks prior to randomization, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the clinical efficacy of oral apremilast 30 mg BID, compared to placebo, in subjects with moderate to severe genital psoriasis during the 16-week Placebo controlled Phase. ;Secondary Objective: The secondary objectives are: - To evaluate the safety and tolerability of apremilast 30 mg BID, compared with placebo, in subjects with moderate to severe genital psoriasis - To evaluate the effect of apremilast 30 mg BID compared with placebo on genital psoriasis symptoms - To evaluate the effect of apremilast 30 mg BID, compared with placebo, on Health-related Quality of Life (HRQoL);Primary end point(s): Static Physician Global Assessment of Genitalia (sPGA-G) 0/1 (modified): Proportion of subjects with a modified sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Static PGA (sPGA) 0/1: Proportion of subjects achieving an overall sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline - Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS): Proportion of subjects with at least a 4-point improvement in GPI-NRS item score within the Genital Psoriasis Symptoms Scale (GPSS) for subjects with a baseline score of = 4 - Body Surface Area (BSA): Change from baseline in affected BSA - Dermatology Life Quality Index (DLQI): Change from baseline in DLQI total score - Genital Psoriasis Symptoms Scale (GPSS): Change from baseline in GPSS total score and individual items scores;Timepoint(s) of evaluation of this end point: Week 16 | — |
Countries
Belgium, Canada, France, Germany, Italy, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed