Adalimumab s.c. for the treatment of patients with hidradenitis suppurativa – clinical efficacy, safety and tolerability - SOPHISTICATE - SOPHISTICATE

Phase 1

Conditions: Patients with hidradenitis suppurativa
MedDRA version: 8.1Level: LLTClassification code 10020041Term: Hidradenitis suppurativa

Registration Number: EUCTR2006-005297-48-DK

Lead Sponsor: niversity of Copenhagen, Roskilde, Department of Dermatology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

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 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.

Secondary Outcome Measures