E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with hidradenitis suppurativa |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020041 |
E.1.2 | Term | Hidradenitis suppurativa |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include investigating the tolerability and safety of Adalimumab in the treatment of patients with HS. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last subject in the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |