Phase 3
N=307
Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
Bottom Line
View on ClinicalTrials.gov: NCT01468207 ↗Enrolled (actual)
307
Serious AEs
3.2%
Results posted
Oct 2015
Primary outcome: Primary: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 — 26.0; 41.8; 29.8; 21.4 percentage of participants — p==0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Biological); placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 |
26.0; 41.8; 29.8; 21.4; 44.6; 38.6 | =0.003 sig |
| SECONDARY Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 |
28.6; 28.9 | =0.961 |
| SECONDARY Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3 |
24.8; 27.9 | =0.628 |
| SECONDARY Change From Baseline to Week 12 in Modified Sartorius Score |
-15.7; -24.4 | =0.124 |
Summary
A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).
Eligibility Criteria
Inclusion Criteria
- Adults must have a diagnosis of HS for at least 1 year prior to Baseline.
- HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.
- Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.
- Subject must have experienced an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of HS.
- Subject must have a total AN count of greater than or equal to 3 at baseline.
Exclusion Criteria
- Subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-TNF) therapy (e.g., infliximab or etanercept).
- Subject received any oral antibiotic treatment for HS within 28 days prior to Baseline.
- Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.
- If entering the study on concomitant oral analgesics for non-HS related pain:
- Subject on opioid analgesics within 14 days prior to Baseline visit;
- Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit ("as needed" is not considered a stable dose).
Data sourced from ClinicalTrials.gov (NCT01468207). 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.