Clinical trial to examine changes in inflammational type of active, moderate-to-severe hidradenitis suppurativa during a 6-week treatment with the approved medication Adalimumab (HUMIRA).
- Conditions
- Hidradenitis suppurativa is defined as a chronic inflammatory disease of the intertriginous area, including the axilla, groin and anogenital or submammary regions. The condition is characterized by inflammation, recurrent abscesses, fistulas and sinus tracts, leading to post-inflammatory contracture and accordion-like mutilating scars. Mostly this disease appears in younger patients from 15 - 45 years and is connected with a high burden of disease and decreased quality of life.Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-000435-13-DE
- Lead Sponsor
- niversity Hospital Frankfurt for its Dermatology Department, Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
Main inclusion criteria
•Diagnosis of HS for minimum of six months
•Disease state diagnosed to be active and moderate to severe HS, requiring systemic therapy
•No severe or otherwise clinically significant abnormalities found within the patient’s medical/medication history, nor during physical examination
•Minimum of one previously failed or insufficiently responded to systemic therapy for HS
•Women of childbearing age who are sexually active must use a highly effective form of contraception (Pearl Index < 1%) for the duration of the study
•Negative test for tuberculosis (TB) according to local guidelines, obtained no more than three months prior to screening
•Written informed consent and availability of any locally required authorization obtained from the subject, prior to performing any protocol-related procedures
•Patients must be able and willing to comply with the requirements of this protocol
•Age 18–65 years
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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Main exclusion criteria
•Previous use of Adalimumab (Humira®) or any other TNF-a inhibitors
Exclusion criteria related to IMP
•According to SmPC
•According to approval status of EMA
•According to approval status of Adalimumab for treatement of HS in Germany
•Known hypersensitivity to any component of the IMP
Exclusion criteria related to general health
•Active dermatologic conditions that may confound the diagnosis of HS or would interfere with the assessment of treatment (e.g., atopic dermatitis, seborrhoic dermatitis, ichthyosis, psoriasis vulgaris, folliculitis)
•History of a clinically significant infection four weeks prior to baseline visit, which, in the opinion of the investigator, may compromise the safety of the subject
•History of chronic alcohol/drug abuse within the last 12 months before screening
•Pregnant or breastfeeding women
•Severe kidney insufficiency (GFR < 30 ml/min)
•Any severe diseases that may, in the opinion of the investigator, interfere or worsen the hidradenitis suppurativa or result in safety concerns for patients being treated with an anti-TNF-alpha Inhibitor
•History or presence of human immunodeficiency virus (HIV), and/or hepatitis B (HBV) or C virus (HCV) infections
•History of active tuberculosis (TB), or untreated or inadequately treated latent TB (LTBI). Subjects must have a negative QuantiFERON, T-SPOT, or purified protein derivative (PPD) test, performed less than three months before the screening visit.
•Any active medication which suppresses the immune system
•History, current signs, symptoms, or diagnosis of a demyelinating disorder
•History of or current Class III or IV congestive heart failure, as defined by the New York Heart Association,
•History or current signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
•Current malignancy or history of any malignancy, except for adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ; no more than a total of three lifetime basal cell or squamous cell carcinomas permitted
•Concurrent enrolment in another clinical trial, in which the subject is receiving an investigational product
•Any major surgery in the last four weeks, that in the opinion of investigator, study related procedures or treatment with an anti-TNF-alpha inhibitor is contraindicated.
•Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease, including pleural effusions or ascites, which, in the opinion of the investigator pose an unacceptable safety risk
•History of latex allergy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method