A global study comparing ABBV-066 to placebo in adult subjects with Hidradenitis Suppurativa
- Conditions
- Hidradenitis SuppurativaMedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-000122-21-ES
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 190
• Subjects must be = 18 years old at Screening with a clinical diagnosis of moderate to severe HS (defined as a total AN count of = 5 at Baseline, presence of HS lesions in at least 2 distinct anatomic areas, and draining fistula count of = 20 at Baseline) for at least 1 year prior to Baseline, as determined by the investigator (i.e., through medical history, interview of subject).
• Subjects must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
• Prior exposure to anti-IL12/23/17 (overall, no more than 10% of the study population)
• Prior exposure to anti-TNF (overall, no more than 15% of the study population)
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 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
No history of active skin disease other than HS that could interfere with the assessment of HS.
No active TB or concurrent treatment for latent TB and no evidence of HBV, HCV or HIV.
No documented active or suspected malignancy or history of any malignancy within the last 5 years.
No history of organ transplantation.
No exposure to other immunomodulatory biologic therapies, including anti-IL-1 within 3 months or 5 half-lives, whichever is longer, prior to Baseline.
No previous treatment with any cell-depleting therapies including but not limited to anti-CD20 within 12 months prior to Baseline or until B cell count returns to normal level.
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 this study is to assess the safety and efficacy of risankizumab dose 1 and dose 2 versus placebo for the treatment of signs and symptoms of moderate to severe HS in adult subjects diagnosed for at least one year before the Baseline visit.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16. HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase in abscess or draining fistula counts.;Timepoint(s) of evaluation of this end point: Week 16
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Week 8 and Week 16;Secondary end point(s): Proportion of subjects achieving at least 30% reduction from Baseline in NRS30 in PGA Skin Pain at Week 8 among subjects with Baseline Numerical Rating Scale (NRS) = 3. <br>Proportion of subjects achieving NRS30 in PGA Skin Pain at Week 16 among subjects with Baseline NRS = 3.<br>Proportion of subjects who experience at least 25% increase in AN counts with a minimum increase of 2 relative to Baseline during Period A. <br>Change from Baseline in DLQI at Week 16.<br>Change from Baseline in HS-related swelling – assessed based on the HSSA at Week 16. <br>Change from Baseline in HS-related odor – assessed based on the HSSA at Week 16. <br>Change from Baseline in HS-related worst drainage – assessed based on the HSSA at Week 16.