A Phase 2 Open-label Single Center Study to Evaluate the Efficacy of Apremilast for the Treatment of Moderate Hidradenitis Suppurativa
Overview
- Phase
- Phase 2
- Intervention
- Apremilast
- Conditions
- Hidradenitis Suppurativa
- Sponsor
- Florida Academic Dermatology Centers
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the safety and efficacy of Apremilast in subjects with moderate Hidradenitis Suppurativa (HS).
Detailed 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: 1. The number of patients achieving a one point reduction in the Physician's Global Assessment (PGA) score at week 16 2. Changes in Modified Sartorius scale from Baseline to Week 16 3. The number of patients achieving a two point reduction (required from baseline score) in the Visual Analog Scale (VAS) pain score at week 16 4. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have the capacity to understand and sign and Informed Consent Form.
- •Subject must be in general good health ( except for Hidradenitis Suppurativa) as judged by the Investigator, based on medical history, physical examination, clinical laboratories and urinalysis. NOTE: the definition of good health means a subjects that does not have uncontrolled significant co-morbid conditions.
- •Must have a diagnosis of Hidradenitis Suppurativa (HS) for at least 6 months prior to Baseline/Screening visit
- •Subjects with moderate Hidradenitis Suppurativa (HS) with a Physician's Global Assessment (PGA) score of 3 defined as having: 0 abscesses, 0 draining fistula, and 5 inflammatory nodules; or 1 abscess or draining fistula and 1 inflammatory nodule; or 2-5 abscesses or draining fistulas and 10 inflammatory nodules
- •Hidradenitis Suppurativa (HS) lesions must be present in at least two distinct anatomic areas, one of which must be at least Hurley Stage II (see definition of terms)
- •Subject must have stable HS for at least 2 months (60 days) prior to Screening/ Baseline visit as determined by the investigator through subject interview and review of medical history;
- •Subject must have a total abscess and inflammatory nodule (AN) count (PGA) of no greater than moderate at the Baseline visit. Patient with PGA 0-1 (No disease or minimal Disease will be excluded).
- •Subject must agree to daily use (and throughout the entirety of the study) of one of the following over-the-counter topical antiseptics on their Hidradenitis Suppurativa (HS) lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater.
- •Women who are postmenopausal must have a negative serum pregnancy test on entry in the study.
- •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:
Exclusion Criteria
- •The presence of any of the following will exclude a subject from enrollment:
- •Subjects with PGA 4 and 5 , with 15 lesions and significant scarring (defined as any linear, indurated area, extended across more than 50% of the circumference of the affected area) ,fistulas or sinus tract involvement will be excluded.
- •Other than Hidradenitis Suppurativa , any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- •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.
- •Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- •Women who are pregnant, nursing, or planning pregnancy within 6 months after the last study drug dose (this includes father's who plan on fathering a child within 6 months after their last study drug dose.
- •Active substance abuse or a history of substance abuse within 6 months prior to Screening
- •Malignancy or history of malignancy, except for:
- •treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas;
- •treated \[ie, cured\] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
Arms & Interventions
Apremilast ( open label)
Investigational Product: Apremilast Doses: Period A: 10mg Per day, day #1, 10mg Twice Per day, day #2 10mg qAM, 20mg qHS day #3 20mg Twice per day, day #4 20mg qAM, 30 mg qHS day #5 30mg Twice per day, day #6 Period B: 30mg Twice per day, day #7 through week #24 Period C: Week 28 (4 weeks off therapy), for final evaluation Mode of Administration: Oral
Intervention: Apremilast
Outcomes
Primary Outcomes
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR)
Time Frame: 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..
Secondary Outcomes
- 3. The number of patients achieving a two point reduction (required from baseline score) in the Visual Analog Scale (VAS) pain score(Week 16)
- The number of patients achieving a one point reduction in the Physician's Global Assessment (PGA) score(Week 16)
- Changes in Modified Sartorius scale from Baseline(From Baseline to Week 16)