acne ectopica acne inversa
Conditions
Interventions
Starting at baseline, all subjects will receive open-label adalimumab 40mg per
week, regardless of treatment assignment in the prior phase-3 study. If at any
time on or after week 24 of the open-lab
- Achieves an AN count of 0 or 1 on at least 2 consecutive study visits, AND
- The physician and subject mutually decide that the risk/benefit of reducing
adalimumab dosing to every other week is favorable.
Sponsors
AbbVie BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Subjects who previously participated in a prior Phase3 HS study (M11-810) and: * completed the study, or * achieved HiSCR at the entry of period B, then experienced a loss of response (LOR) defined as an AN count that is greater than the average of AN counts at baseline and week 12 of the prior Phase 3 HS study; or * did not achieve HiSCR at the entry of period B, then experienced worsening or absence of improvement on or after week 16 of the prior phase 3 HS study, defined as an AN count * Baseline AN count at two consecutive visits (excluding week 12) occurring * 14 days apart 2) If female, subject is either: * Not of childbearing potential, defined as postmenopausal for at least 1 year (365 days); or * Surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy; or * Of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. 3) Subject must agree to daily use (throughout the entirety of the study) of one of the following over-the-counter topical antiseptics on their body areas affected with HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with any other anti-TNF therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 HS study. 2. Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of hidradenitis suppurativa. 3. Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit of Study M12-555, except for antibiotics permitted in a prior Phase 3 HS study. 4. Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit of Study M12-555. 5. Subject received systemic non-biologic therapies with potential therapeutic impact for HS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following efficacy variables will be determined throughout the study to evaluate the long-term efficacy of adalimumab to treat moderate to severe HS: HiSCR Abcess count Draining fistula count Non-draining fistula count Inflammatory nodule count Non-inflammatory nodule count Hypertrophic scar count AN-count Modified Sartorius-score erythema Hurley Stage at eacht affected anatomic region Patient global assessment of skin pain DLQI WPAI:SHP TSQM | — |
Countries
Netherlands
Outcome results
None listed