Phase 3
Completed N=508
Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa
Source: ClinicalTrials.gov NCT01635764 ↗Enrolled (actual)
508
Serious AEs
19.5%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit — 34.1; 39.8; 34.1; 38.6 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit |
34.1; 39.8; 34.1; 38.6; 41.1; 40.2 | — |
| PRIMARY Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit |
26.1; 54.4; 57.9; 57.0; 60.5; 57.0 | — |
| PRIMARY Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit |
19.5; 46.7; 51.6; 48.4; 57.4; 55.7 | — |
| PRIMARY Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit |
22.7; 28.4; 38.6; 35.2; 37.5; 42.0 | — |
| PRIMARY Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit |
31.1; 22.8; 21.1; 35.6; 34.8; 44.3 | — |
| PRIMARY Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit |
20.0; 38.6; 43.0; 42.1; 43.9; 45.6 | — |
| PRIMARY Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population |
-18.0; -21.0; -22.8; -23.9; -26.6; -32.1 | — |
| PRIMARY Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations |
-23.1; -10.5; 0.2; -30.2; -18.8; -16.2 | — |
| PRIMARY Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population |
-18.0; -43.2; -43.0; -49.5; -47.1; -46.2 | — |
| PRIMARY Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 |
47.6; 46.0; 44.4; 42.9; 46.0; 50.8 | — |
| PRIMARY Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 |
40.0; 21.9; 22.6; 47.5; 43.1; 44.6 | — |
| PRIMARY Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 |
31.6; 51.6; 55.3; 55.8; 53.2; 58.4 | — |
| PRIMARY Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 |
56.0; 52.0; 48.0; 46.0; 40.0; 50.0 | — |
| PRIMARY Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 |
43.6; 37.7; 31.9; 49.0; 46.8; 61.8 | — |
| PRIMARY Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3 |
30.6; 59.2; 61.0; 61.7; 53.3; 60.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who previously participated in a prior Phase 3 AbbVie hidradenitis suppurativa (HS) study (M11-313 or M11-810) and:
- Completed the study; or
- Experienced a loss of response (LOR); or
- Experienced worsening or absence of improvement
Exclusion Criteria
- Prior treatment with any other anti-tumour necrosis factor (anti-TNF) therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 AbbVie HS study.
- Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit, except for antibiotics permitted in a prior Phase 3 AbbVie HS study.
- Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit of Study M12-555.
Data sourced from ClinicalTrials.gov (NCT01635764). 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.