E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hidradenitis Suppurativa (also known as Acne inversa) |
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E.1.1.1 | Medical condition in easily understood language |
A painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and ooze purulent drainage, and cause subsequent scarring. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020041 |
E.1.2 | Term | Hidradenitis suppurativa |
E.1.2 | System Organ Class | 100000004858 |
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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 |
Assess the safety and efficacy of adalimumab prior to surgery in subjects with moderate to severe Hidradenitis Suppurativa (HS) who are surgical candidates. |
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E.2.2 | Secondary objectives of the trial |
- Assess the impact of adalimumab on the planned HS surgical site before surgery
- Evaluate the safety and efficacy of adalimumab when used after surgery, and
- Evaluate Patient Reported Outcomes (PRO) related to health status, HS-related symptoms, physical functioning, treatment satisfaction, and work/activity impairment.
- Evaluate the pharmacokinetics (PK) and immunogenicity of adalimumab. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male and female subjects between the ages of 18 and 65, inclusive
- Subject must have skin lesions that are diagnostic of HS for at least 1 year (365 days) prior to the Baseline visit
- Subject must have at least 3 distinct anatomical regions involved with inflammatory ( also termed ‘active’) HS lesions; including
(a) either an axilla or unilateral inguinal region (limited to the inguinal-crural fold and adjacent areas) that requires excisional surgery (hereinafter designated the “HS surgical site”), and
(b) with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region; hereinafter designated the 'HS non-surgical sites) rated as Hurley Stage II or III
- Subject must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS non-surgical sites
- The HS surgical site must contain at least one active HS lesion
- The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon
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E.4 | Principal exclusion criteria |
- Subject has a draining fistula count of greater than 20 at the Baseline visit
- Subject requires surgery at any anatomical site other than an unilateral axilla or inguinal region site
- Subject requires surgical management prior to Week 13, based on the designated surgeon's assessment
- Subject requires, based on designated surgeon's assessment, excisional surgery with primary closure, partial surgical reduction of the excised area with surgical suture, or reconstruction techniques as the method of closure being most beneficial for the subject
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E.5 End points |
E.5.1 | Primary end point(s) |
- The primary efficacy variable is the proportion of subjects achieving HiSCR (Hidradenitis Suppurativa Clinical Response). HiSCR is defined as at least a 50% reduction in the AN count with no increase in abscess count and no increase in draining fistula count relative to baseline. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- The proportion of subjects achieving HiSCR-es (defined as the HiSCR excluding the HS surgical site) at Weeks 12 and 24
- The percent change in surface area of the surgical site, and
- The proportion of subjects at Week 12 that require less extensive surgical than the surgical plan (determined at Baseline) or no surgery. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Colombia |
European Union |
Israel |
Mexico |
Norway |
Russian Federation |
Saudi Arabia |
Turkey |
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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
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LVLS or the last follow-up contact whichever is longer. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |