A Phase 4 interventional study of Placebo and Adalimumab in Hidradenitis Suppurativa (HS), sponsored by AbbVie. Completed at 55 sites in 23 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-05-14.
Sponsored by AbbVie · Phase 4, Interventional, and Treatment
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.
This was an interventional, randomized, double-blind (DB), placebo-controlled study. The study duration included a 30-day Screening Period, an initial 12-week DB treatment pre-surgery period (Period A), a 2-week peri-operative period with continuation of weekly DB study drug administration (Period B), and a subsequent 10-week DB treatment post-operative period (Period C). Randomization (in a 1:1 ratio) in Period A was stratified by baseline Hurley Stage (II versus III) and anatomical location of the planned surgical site (i.e., axilla versus inguinal region). The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded. In Period B, the designated surgeon measured and recorded the surface area of the actual surgery, with surgery occurring during Week 13. Surgery and post-operative management (e.g., hospitalization, surgical wound care) was per local practice. No study drug was administered at Week 24, the final study visit. Participants were able to begin commercial product (as prescribed by the participants's physician) after all Week 24 procedures were completed.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's enrollment of 206 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participant must have at least 3 distinct anatomical regions involved with inflammatory (also termed 'active') HS lesions; plus
Exclusion Criteria:
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week Period B: Weeks 13-14- 1 SC injection each week Period C: Weeks 15-23- 1 SC injection each week
Drug: Placebo
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week Period B: Weeks 13-14- 1 SC 40 mg injection each week Period C: Weeks 15-23- 1 SC 40 mg injection each week
Drug: Adalimumab
Subcutaneous injections administered as described in arm description
Subcutaneous injections administered as described in arm description
Also known as: Humira
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
HiSCR is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Time frame: At Week 12
Percentage of Participants Achieving HiSCR-es at Week 12
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
Time frame: At Week12
Percentage of Participants Achieving HiSCR-es at Week 24
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
Time frame: At Week 24
Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented.
Time frame: From Baseline to Week 12
Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented, and the percentage of participants at Week 12 requiring a less extensive surgery than the surgical plan (determined at Baseline) or no surgery as determined by the designated surgeon was recorded.
Time frame: At Week 12
| Milestone | Placebo | Adalimumab |
|---|---|---|
| Started | 103 | 103 |
| Completed | 81 | 84 |
| Not completed | 22 | 19 |
| Withdrew: Adverse event | 3 | 4 |
| Withdrew: Withdrew consent | 9 | 8 |
| Withdrew: Lost to follow-up | 4 | 6 |
| Withdrew: Planned hs surgery performed prior wk 13 | 1 | 0 |
| Withdrew: Other, not specified | 5 | 1 |
HiSCR is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
| percentage of participants | Placebo | Adalimumab |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | 34.0 (24.8 to 43.1) | 47.6 (37.9 to 57.2) |
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
| percentage of participants | Placebo | Adalimumab |
|---|---|---|
| Percentage of Participants Achieving HiSCR-es at Week 12 | 35.0 (25.7 to 44.2) | 47.6 (37.9 to 57.2) |
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
| percentage of participants | Placebo | Adalimumab |
|---|---|---|
| Percentage of Participants Achieving HiSCR-es at Week 24 | 31.1 (22.1 to 40.0) | 51.5 (41.8 to 61.1) |
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented.
| percent change from Baseline | Placebo | Adalimumab |
|---|---|---|
| Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12 | 26.233 (-31.684 to 84.150) | 68.190 (8.485 to 127.896) |
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented, and the percentage of participants at Week 12 requiring a less extensive surgery than the surgical plan (determined at Baseline) or no surgery as determined by the designated surgeon was recorded.
| percentage of participants | Placebo | Adalimumab |
|---|---|---|
| Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery | 43.7 (33.3 to 54.1) | 46.3 (35.5 to 57.1) |
Collected over Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/103 (0%) | 3/103 (2.9%) | 43/103 (41.7%) |
| Adalimumab | 2/103 (1.9%) | 7/103 (6.8%) | 48/103 (46.6%) |
| Event | Placebo | Adalimumab |
|---|---|---|
| HIDRADENITISSkin and subcutaneous tissue disorders | 2/103 | 0/103 |
| CARDIOVASCULAR DISORDERCardiac disorders | 1/103 | 0/103 |
| CHOLELITHIASISHepatobiliary disorders | 0/103 | 1/103 |
| BLASTOCYSTIS INFECTIONInfections and infestations | 0/103 | 1/103 |
| POSTOPERATIVE WOUND INFECTIONInfections and infestations | 1/103 | 0/103 |
| RESPIRATORY TRACT INFECTIONInfections and infestations | 0/103 | 1/103 |
| MUSCULOSKELETAL CHEST PAINMusculoskeletal and connective tissue disorders | 0/103 | 1/103 |
| PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders | 0/103 | 1/103 |
| TESTIS CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/103 | 1/103 |
| RUPTURED CEREBRAL ANEURYSMNervous system disorders | 0/103 | 1/103 |
| Event | Placebo | Adalimumab |
|---|---|---|
| NASOPHARYNGITISInfections and infestations | 19/103 | 19/103 |
| HIDRADENITISSkin and subcutaneous tissue disorders | 15/103 | 14/103 |
| PROCEDURAL PAINInjury, poisoning and procedural complications | 8/103 | 14/103 |
| HEADACHENervous system disorders | 14/103 | 13/103 |
| DIARRHOEAGastrointestinal disorders | 4/103 | 6/103 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 1/103 | 6/103 |
| DIZZINESSNervous system disorders | 6/103 | 2/103 |
Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit
| Age, Continuous(years) | Placebo | Adalimumab | Total |
|---|---|---|---|
| Mean | 36.8 ± 10.81 | 38.5 ± 11.71 | 37.6 ± 11.27 |
| Sex: Female, Male(Participants) | Placebo | Adalimumab | Total |
|---|---|---|---|
| Female | 55 | 51 | 106 |
| Male | 48 | 52 | 100 |
| Race/Ethnicity, Customized(Participants) | Placebo | Adalimumab | Total |
|---|---|---|---|
| White | 97 | 96 | 193 |
| Black or African American | 4 | 4 | 8 |
| Asian | 1 | 1 | 2 |
| American Indian or Alaska Native | 0 | 2 | 2 |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 |
| Multiple | 0 | 0 | 0 |
| Missing | 1 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr, Analytic code
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