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The primary objective of this study is to evaluate the safety and efficacy of Apremilast in subjects with moderate Hidradenitis Suppurativa (HS).
Full description
This study is an open-label 28-week trial. All Subjects will receive Apremilast with the initial titrating dose as per package insert (10mg per day on day #1, escalating to 30mg twice daily at day #6 and continuation at this dose).
The primary efficacy endpoint is:
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16, defined as a 30% reduction in the total number of abscess and inflammatory nodule count with a 50% reduction as an exploratory endpoint..
The Secondary endpoints are:
The number of patients achieving a one point reduction in the Physician's Global Assessment (PGA) score at week 16 Changes in Modified Sartorius scale from Baseline to Week 16 The number of patients achieving a two point reduction (required from baseline score) in the Visual Analog Scale (VAS) pain score at week 16 Dermatology Life Quality Index or DLQI,
The study will be conducted over 24 weeks on active therapy followed by a four week observational visit. The total length of the study will be 28 weeks.
Study visits will occur at Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, and then a observational follow up 4 weeks afterwards. Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
Adverse events will be collected throughout the study.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:• Have the capacity to understand and sign and Informed Consent Form.
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.
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.
† 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).
The screening/baseline laboratory test results must meet the following criteria (WNL means within normal limits for patients with HS [e.g., may have slightly higher WBC and platelet counts]):
WBC (white blood cell count): WNL
ANC (absolute neutrophil count): WNL
Hemoglobin: >10 mg/dl
Platelets: WNL
Serum Creatinine: WNL
SGOT (AST - aspartate aminotransferase): <2 times upper normal limit
SGPT (ALT - alanine aminotransferase): <2 times upper normal limit
Alkaline phosphatase:<2 times upper normal limit
Exclusion Criteria:
Primary purpose
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20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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