Patients with hidradenitis suppurativa MedDRA version: 8.1 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa
Conditions
Interventions
Trade Name: HUMIRA
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Sponsors
University of Copenhagen, Roskilde, Department of Dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (>=18 years) with moderate to severe HS, defined as a Hurley stage II or III, for more than 6 months, and not responding adequately to conventional therapy will be included. Female patients of childbearing potential should have a negative pregnancy test (serum HCG) prior to start of study treatment. [Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)], and further, should use a reliable method of contraception e.g. intra-uterine devices or hormone contraceptives (oral, implantable, or injectable) during the entire study and 150 days after cessation of study medication. 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
Exclusion criteria: Discharging HS lesions with defined microbial pathogens (Staphylococcus aureus or Streptococcus pyogenes, Group A). Use of conventional therapy for HS including but not limited to antibiotics, oestrogens/cyproterone acetate and surgery 4 weeks prior to baseline and during the 12 weeks’ treatment phase and biological therapies 12 weeks prior to baseline and during the 12 weeks’ treatment phase, or during the follow-up period as defined in this protocol, is not allowed. Patients with positive serology for hepatitis B or C indicating active infection, immuno-compromised conditions or history of HIV, history of listeriosis, history of histoplasmosis, active or latent TB, persistent chronic or active infections requiring hospitalisation and/or treatment with i.v. antibiotics, i.v. antivirals, or i.v. antifungals within 30 days or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to screening are excluded. Patients with a history of malignancy are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to investigate the clinical efficacy of Adalimumab in the treatment of patients with hidradenitis suppurativa (HS) as evaluated by a Physician’s HS scoring system at week 12.;Secondary Objective: Secondary objectives include investigating the tolerability and safety of Adalimumab in the treatment of patients with HS. ;Primary end point(s): Primary efficacy endpoint:To investigate the clinical efficacy of Adalimumab in the treatment of patients with HS as evaluated by the percentage change relative to baseline of the Physician’s HS scoring system at week 12. | — |
Countries
Denmark
Outcome results
None listed