Phase 2
Completed N=154
Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Source: ClinicalTrials.gov NCT00918255 ↗Enrolled (actual)
154
Serious AEs
5.8%
Results posted
May 2011
Primary outcomePrimary: Percentage of Participants Achieving Clinical Response at Week 16 — 17.6; 9.6; 3.9 percentage of participants — p=0.022
Summary
This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Clinical Response at Week 16 |
17.6; 9.6; 3.9 | 0.022 sig |
| SECONDARY Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16 |
-50.66; -30.43; -13.66 | 0.062 |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 2 |
2.0; 9.6; 2.0 | 1.000 |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 4 |
11.8; 5.8; 2.0 | 0.044 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 8 |
7.8; 5.8; 7.8 | 1.000 |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 12 |
21.6; 7.7; 5.9 | 0.012 sig |
| SECONDARY Change From Baseline in Modified Sartorius Scale at Week 16 |
-30.0; -16.0; -7.5 | 0.045 sig |
| SECONDARY Change From Baseline in Modified Sartorius Scale at Week 52 |
— | — |
| SECONDARY Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adults with stable, moderate to severe hidradenitis suppurativa
- Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy.
- Ability to administer subcutaneous injections
- General good health otherwise
Exclusion Criteria
- Prior anti-TNF therapy
- Unstable antibiotic therapy for HS
- Required medication washouts for other HS treatments
- Prior exposure to Tysabri® (natalizumab);
- Recent infection requiring treatment
- Significant medical events or conditions that may put patients at risk for participation
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
- History of cancer, except successfully treated skin cancer
- Recent history of drug or alcohol abuse
Data sourced from ClinicalTrials.gov (NCT00918255). 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. Informational only — not medical advice.