Phase 4
N=206
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
Hidradenitis Suppurativa (HS)
Bottom Line
View on ClinicalTrials.gov: NCT02808975 ↗Enrolled (actual)
206
Serious AEs
4.9%
Results posted
May 2020
Primary outcome: Primary: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 — 34.0; 47.6 percentage of participants — p==0.049
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Adalimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 |
34.0; 47.6 | =0.049 sig |
| SECONDARY Percentage of Participants Achieving HiSCR-es at Week 12 |
35.0; 47.6 | =0.067 |
| SECONDARY Percentage of Participants Achieving HiSCR-es at Week 24 |
31.1; 51.5 | =0.003 sig |
| SECONDARY Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12 |
26.233; 68.190 | =0.313 |
| SECONDARY Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery |
43.7; 46.3 | =0.746 |
Summary
The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.
Eligibility Criteria
Inclusion Criteria
- Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the Baseline visit
- Participant must have at least 3 distinct anatomical regions involved with inflammatory (also termed 'active') HS lesions; plus
- either one axilla or one inguinal region (limited to the inguino-crural fold and adjacent areas) that requires excisional surgery, and
- with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region) rated as Hurley Stage II or III
- Participant 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
Exclusion Criteria
- Participant has a draining fistula count of greater than 20 at the Baseline visit
- Participant requires surgery at any anatomical site other than an unilateral axilla or inguinal region site
- Participant requires surgical management prior to Week 13
- Participant requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant
Data sourced from ClinicalTrials.gov (NCT02808975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.