A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Hidradenitis Suppurativa

• Conditions: Hidradenitis Suppurativa (HS) is a painful, chronic, skin disease characterized by recurrent inflamed nodules, abscesses, and fistulas, which may heal with scarring. The most commonly involved anatomic locations are the inguino-crural and axillary folds, with sub-mammary folds (in women) and the perineal area less commonly involved.; MedDRA version: 9.1Level: LLTClassification code 10020041Term: Hidradenitis suppurativa

• Registration Number: EUCTR2008-004587-38-DK
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Male and female subjects at least 18 years of age;
2. Subjects must have a diagnosis of HS for at least 6 months (180 days) prior to
Baseline that involves at least two distinct anatomic areas (e.g., left and right
axilla; or left axilla and left inguinal-crural fold);
3. Subjects must be unresponsive or intolerant, as determined by the investigator, to oral antibiotics for treatment for
their HS;
4. Subject must have stable hidradenitis suppurativa for at least 2 months (60 days)
before Screening and also at the Baseline visit as determined by subject interview
of his/her medical history;
5. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is 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. The results of the serum pregnancy test performed during the Screening Period and urine pregnancy test performed at the Baseline Visit must be negative.
Examples of approved mehtods of birth control include the following:
? Barrier methods (condoms or intrauterine device)
? Contraceptives (oral, parenteral, transdermal or implantable) for three months
(90 days) prior to study drug administration
? Vasectomized partner
6. Subject has a negative PPD test (or equivalent) and CXR (PA and lateral view) at
Screening (See Section 5.3.1.1 of the study protocol). If the subject had a positive PPD test (or equivalent), has had a past ulcerative reaction to PPD placement and/or a CXR consistent with prior TB exposure, the subject must initiate, or have documented completion of a course of anti-TB therapy; (See Section 5.3.1.1 of the protocol).
7. Subject has a PGA of at least moderate disease (score of > 3) at the Baseline visit;
8. Subject is judged to be in good general health, as determined by investigator based upon the results of a medical history, laboratory evaluations, chest x-ray (CXR)12-lead ECG, and the physical examination performed during the Screening period and confirmed at Baseline;
9. Ability and willingness to self-administer SC injections or have available qualified
person(s) who can reliably administer SC injections;
10. Ability and willingness to give written informed consent and to comply with the
requirements of the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior treatment with adalimumab or other anti-TNF therapy (e.g., infliximab or etanercept) , or participation in an adalimumab trial;
2. Any other active skin disease or condition (e.g., bacterial, fungal or viral infection)
that may interfere with assessment of hidradenitis suppurativa;
3. Subjects on allowable oral and/or topical antibiotic treatment for HS who have
not been on a stable dose for at least 4 weeks prior to the Baseline visit.
(See Section 5.2.3 of the study protocol for medications).
4. Subject received systemic non-biologic therapies for hidradenitis suppurativa
< 4 weeks prior to Baseline visit (other than oral and/or topical antibiotics);
5. Received any investigational agent within 30 days or 5 half lives prior to Baseline
(whichever is longer), or within a duration of its known pharmacological activity;
6. Subject received UVB phototherapy within 2 weeks of Baseline;
7. Subject received PUVA phototherapy within 4 weeks of Baseline;
8. Prior exposure to Tysabri (natalizumab);
9. Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or
IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals,
or oral antifungals within 14 days prior to Baseline, except as required as part of an anti-TB regimen;
10. History of moderate to severe congestive heart failure (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 CNS demyelinating disease or neurologic symptoms suggestive of CNS
demyelinating disease;
12. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection,
human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
chronic recurring infections or active TB;
13. Known hypersensitivity to the excipients of adalimumab as stated in the label;
14. Positive pregnancy test at screening or Baseline;
15. Female subjects who are breast-feeding or considering becoming pregnant during the study;
16. Evidence of dysplasia or history of malignancy (including lymphoma and
leukemia) other than a successfully treated non-metastatic cutaneous squamous
cell, basal cell carcinoma or localized carcinoma in situ of the cervix;
17. History of clinically significant drug or alcohol abuse in the last 12 months;
18. Clinically significant abnormal screening laboratory results as evaluated by the Investigator;
19. 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to determine the clinical efficacy and safety of adalimumab in subjects with moderate to severe chronic hidradenitis suppurativa (HS) after 16 weeks of treatment. ;Secondary Objective: The secondary objective is to determine maintenance of efficacy and continued safety of adalimumab 40 mg for an additional 36 weeks. The pharmacokinetics and immunogenicity of adalimumab following subcutaneous (SC) injection will also be assessed.;Primary end point(s): The primary efficacy variable is the proportion of subjects achieving clinical response, defined as achieving a PGA of clear, minimal, or mild, with a minimum of 2 grades improvement (reduction) from Baseline on the PGA at Week 16.