EUCTR2008-004587-38-NLActive, not recruitingNot Applicable
A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Hidradenitis Suppurativa
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Abbott GmbH & Co. KG
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 to oral antibiotics for treatment for
- •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.
- •? 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) and/or CXR (PA and/or lateral view), consistent with prior TB
- •exposure, the subject must have had one of the following:
- •a) Prophylactic treatment initiated prior to administration of study drug;
- •however the course of prophylaxis need not be completed prior to the
- •onset of study drug. Prophylactic treatment will be according to Appendix D of the study protocol (United States Centers for Disease Control [CDC] recommended preventive therapy for TB) or per local guidelines as approved by the Abbott Medical Monitor.
- •b) Subject has documented prophylactic treatment for TB in the past and does not need to repeat this treatment or TB prophylaxis is ongoing.
- •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, 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 (e.g., infliximab or etanercept) anti-TNF
- •therapy, 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. Prior exposure to Tysabri® (natalizumab);
- •7. 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;
- •8. 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;
- •9. History of CNS demyelinating disease or neurologic symptoms suggestive of CNS
- •demyelinating disease;
- •10. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection,
- •human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
- •chronic recurring infections or active TB;
- •11. Known hypersensitivity to the excipients of adalimumab as stated in the label;
- •12. Female subjects who are pregnant or breast-feeding or considering becoming
- •pregnant during the study;
- •13. 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;
- •14. History of clinically significant drug or alcohol abuse in the last 12 months;
- •15. 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.
Investigators
Similar Trials
Active, not recruiting
Not Applicable
A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Hidradenitis SuppurativaHidradenitis 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 suppurativaEUCTR2008-004587-38-DKAbbott GmbH & Co. KG150
Active, not recruiting
Not Applicable
A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Hidradenitis SuppurativaEUCTR2008-004587-38-DEAbbott GmbH & Co. KG150
Recruiting
Phase 2
Multicenter Phase II Study of the Safety and Efficacy of Nilotinib in Patients with Chronic Phase Chronic Myelogenous Leukemia Showing a Major Molecular Response to ImatinibChronic Myelogenous LeukemiaJPRN-UMIN000007140Cooperative study between the West Japan Hematology Study Group and the Clinical Research Support Center Kyushu130
Recruiting
Phase 2
Study of KTE-X19 in Adult Japanese Subjects with Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic LeukemiaJPRN-jRCT2063230095Asou Hiroya21
Active, not recruiting
Not Applicable
A multicenter phase II study to evaluate safety and efficacy of glutadon once weekly (GDO) in patients with metastatic colorectal cancer resistant or intolerable to approved chemo- and molecular-targeted therapiesEUCTR2009-017871-13-PLew Medical Enzymes AG