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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

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 < 28 days prior to Baseline visit of Study M12-555.
6. Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to the Baseline visit of Study M12-555, except for permitted analgesics taken in the prior Phase 3 HS study.
7. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Baseline visit other than investigational drug taken in a prior Phase 3 HS study.
8. Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
9. Infection(s) requiring treatment with intravenous (IV) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to the Baseline visit of Study M12-555 or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to the Baseline visit of Study M12-555, except as required as part of an anti-TB regimen or as permitted in a prior Phase 3 HS study.
10. History of moderate to severe congestive heart failure (New York Health Association [NYHA] class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator would put the subject at risk by participation in the protocol.
11. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
12. History of invasive infection (e.g., listeriosis, histoplasmosis), human immunodeficiency virus (HIV).
13. Subject has an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study.
14. Chronic recurring infections or active TB.
15. Known hypersensitivity to adalimumab or its excipients as stated in Section 5.5.2, Table 3.
16. Positive pregnancy test at Baseline.
17. Female subjects who are breast-feeding or considering becoming pregnant during the study.
18. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ of the cervix.
19. History of clinically significant drug or alcohol abuse in the last 12 months (365 days).
20. Clinically significant abnormal laboratory results as evaluated by the investigator.
21. Subject is considered by the investigator for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The following efficacy variables will be determined throughout the study to<br /><br>evaluate the long-term efficacy of adalimumab to treat moderate to severe HS:<br /><br>HiSCR<br /><br>Abcess count<br /><br>Draining fistula count<br /><br>Non-draining fistula count<br /><br>Inflammatory nodule count<br /><br>Non-inflammatory nodule count<br /><br>Hypertrophic scar count<br /><br>AN-count<br /><br>Modified Sartorius-score<br /><br>erythema<br /><br>Hurley Stage at eacht affected anatomic region<br /><br>Patient global assessment of skin pain<br /><br>DLQI<br /><br>WPAI:SHP<br /><br>TSQM</p><br>

Secondary Outcome Measures