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CompletedNCT01468233PIONEER IIUpdated Jul 12, 2021Results posted

Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa

A Phase 3 interventional study of adalimumab and placebo in Hidradenitis Suppurativa (HS), sponsored by AbbVie (prior sponsor, Abbott). Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-07-12.

Sponsored by AbbVie (prior sponsor, Abbott) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
326
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).

Read the detailed description

The clinical trial identifier is PIONEER II. The purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe HS. HS is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. Sometimes these bumps can heal themselves quickly and sometimes they will become much worse and create sores that heal with multiple combined scars, or areas that do not heal. In this study, approximately 300 adults will be enrolled at treatment centers worldwide. Subject participation in this study will be up to 50 weeks. There will be a screening period, which will last from 7 to 30 days, and a study treatment period of up to 36 weeks. Study visits occur at Screening, Baseline, and Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves the study before Week 36). The study is divided into two treatment periods. The first period (Period A) will last 12 weeks and the second period (Period B) will last 24 weeks.

02

Conditions studied

  • Hidradenitis Suppurativa (HS)

Keywords

  • placebo controlled
  • double blind
  • adalimumab
  • TNF
  • psoriasis
  • HS
  • PIONEER II
  • hidradenitis suppurativa
  • acne inversa
  • boil
  • acne
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 326 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-TNF) therapy (e.g., infliximab or etanercept).
  • Subjects on permitted oral antibiotic treatment for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit.
  • 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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
326 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo for 12 weeks.

    Biological: placebo

  • Experimental
    Adalimumab Every Week (EW)

    Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).

    Biological: adalimumab

  • Placebo comparator
    Placebo/Placebo

    Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).

    Biological: placebo

  • Experimental
    Adalimumab Every Week (EW)/Placebo

    Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

    Biological: adalimumab · Biological: placebo

  • Experimental
    Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)

    Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).

    Biological: adalimumab

  • Experimental
    Adalimumab Every Week (EW)/Adalimumab Every Week (EW)

    Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

    Biological: adalimumab

Interventions

  • Biologicaladalimumab

    Adalimumab pre-filled syringe, administered by subcutaneous injection

    Also known as: Humira

  • Biologicalplacebo

    Placebo pre-filled syringe, administered by subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

    HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.

    Time frame: Baseline (Week 0) up to Week 12

Secondary outcomes

  1. Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12

    The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered nonresponders.

    Time frame: Baseline (Week 0) up to Week 12

  2. 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

    The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders.

    Time frame: Baseline (Week 0) up to Week 12

  3. Change From Baseline to Week 12 in Modified Sartorius Score

    The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.

    Time frame: Baseline (Week 0) and Week 12

07

Results

Posted Oct 28, 2015

Participant flow

Participants ≥ 18 years of age with HS for at least 1 year prior to Baseline and HS lesions present in at least 2 distinct anatomical areas (one of which must be at least Hurley Stage II or III) who had experienced inadequate response to ≥ 90 day treatment of oral antibiotics for HS were eligible for enrolment in the study.

Treatment Period 1
Participant flow — Treatment Period 1
MilestonePlaceboAdalimumab Every Week (EW)Placebo/PlaceboAdalimumab Every Week (EW)/PlaceboAdalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
Started1631630000
Completed1511550000
Not completed1280000
Withdrew: Adverse event530000
Withdrew: Withdrawal by subject340000
Withdrew: Lost to follow-up300000
Withdrew: Other110000
Treatment Period 2
Participant flow — Treatment Period 2
MilestonePlaceboAdalimumab Every Week (EW)Placebo/PlaceboAdalimumab Every Week (EW)/PlaceboAdalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
Started00151515351
Completed0040232528
Not completed00111282823
Withdrew: Adverse event003021
Withdrew: Lack of efficacy009201
Withdrew: Withdrawal by subject009111
Withdrew: Loss/absence of response (per protocol)0084252220
Withdrew: Lost to follow-up003020
Withdrew: Other003010

Outcome measures

PrimaryPercentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.

Time frame:
Baseline (Week 0) up to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
percentage of participantsPlaceboAdalimumab Every Week (EW)Placebo - Baseline Hurley Stage IIPlacebo - Baseline Hurley Stage IIIAdalimumab Every Week (EW) - Baseline Hurley Stage IIAdalimumab Every Week (EW) - Baseline Hurley Stage III
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 1227.658.936.817.162.455.1
Statistical analysis
  • Placebo vs Adalimumab Every Week (EW) · Cochran-Mantel-Haenszel · p = <0.001 (P-value adjusted for baseline Hurley Stage and for baseline antibiotic use (Y/N).) · Adjusted mean difference: 31.5 · 95% CI 20.7 to 42.2
  • Placebo - Baseline Hurley Stage II vs Adalimumab Every Week (EW) - Baseline Hurley Stage II · Cochran-Mantel-Haenszel · p = <0.001 (P-value adjusted for baseline antibiotic use (Y/N).) · Adjusted mean difference: 25.5 · 95% CI 10.5 to 40.5
  • Placebo - Baseline Hurley Stage III vs Adalimumab Every Week (EW) - Baseline Hurley Stage III · Cochran-Mantel-Haenszel · p = <0.001 (P-value adjusted for baseline antibiotic use (Y/N).) · Adjusted mean difference: 38.1 · 95% CI 22.8 to 53.3
SecondaryPercentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12

The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered nonresponders.

Time frame:
Baseline (Week 0) up to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12
percentage of participantsPlacebo - Baseline Hurley Stage IIEvery Week (EW) - Baseline Hurley Stage II
Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 1232.251.8
Statistical analysis
  • Placebo - Baseline Hurley Stage II vs Every Week (EW) - Baseline Hurley Stage II · Cochran-Mantel-Haenszel · p = =0.01 (P-value adjusted for baseline antibiotics use (Y/N).) · Adjusted mean difference: 19.5 · 95% CI 4.7 to 34.2
SecondaryPercentage 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

The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders.

Time frame:
Baseline (Week 0) up to Week 12
Reported as:
Number · percentage of participants
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
percentage of participantsPlacebo - Baseline NRS at Worst ≥ 3Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3
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 ≥ 320.745.7
Statistical analysis
  • Placebo - Baseline NRS at Worst ≥ 3 vs Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3 · Cochran-Mantel-Haenszel · p = <0.001 (P-value adjusted for baseline Hurley Stage and antibiotics use (Y/N).) · Adjusted mean difference: 25.1 · 95% CI 12.7 to 37.6
SecondaryChange From Baseline to Week 12 in Modified Sartorius Score

The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.

Time frame:
Baseline (Week 0) and Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline to Week 12 in Modified Sartorius Score
units on a scalePlaceboAdalimumab Every Week (EW)
Change From Baseline to Week 12 in Modified Sartorius Score-9.5 ± 3.84-28.9 ± 3.85
Statistical analysis
  • Placebo vs Adalimumab Every Week (EW) · ANCOVA · p = <0.001 (P-value calculated from ANCOVA with stratum (baseline Hurley Stage and antibiotics use), baseline value, and treatment as covariates.) · Ls mean difference: -19.4 · 95% CI -28.6 to -10.1

Adverse events

Collected over Adverse Events were collected from first dose of study drug until 70 days following last dose of study drug (46 weeks); Serious Adverse Events were collected from the time that informed consent was obtained (up to 50 weeks).. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (Period 1)—6/163 (3.7%)77/163 (47.2%)
Adalimumab EW (Period 1)—3/163 (1.8%)66/163 (40.5%)
Placebo/Placebo (Period 2)—7/151 (4.6%)48/151 (31.8%)
Adalimumab EW/Placebo (Period 2)—0/51 (0%)27/51 (52.9%)
Adalimumab EW/Adalimumab EOW (Period 2)—2/53 (3.8%)25/53 (47.2%)
Adalimumab EW/Adalimumab EW (Period 2)—2/51 (3.9%)21/51 (41.2%)
Most frequent serious events
Showing 10 of 27
Most frequent serious events
EventPlacebo (Period 1)Adalimumab EW (Period 1)Placebo/Placebo (Period 2)Adalimumab EW/Placebo (Period 2)Adalimumab EW/Adalimumab EOW (Period 2)Adalimumab EW/Adalimumab EW (Period 2)
PNEUMONIAInfections and infestations0/1630/1630/1510/510/531/51
RASHSkin and subcutaneous tissue disorders0/1630/1630/1510/510/531/51
LYMPHADENITISBlood and lymphatic system disorders0/1630/1630/1510/511/530/51
ACUTE MYOCARDIAL INFARCTIONCardiac disorders0/1630/1630/1510/511/530/51
CARDIO-RESPIRATORY ARRESTCardiac disorders0/1630/1630/1510/511/530/51
HIDRADENITISSkin and subcutaneous tissue disorders2/1630/1631/1510/511/530/51
ATRIAL FIBRILLATIONCardiac disorders0/1630/1631/1510/510/530/51
APPENDICITISInfections and infestations0/1630/1631/1510/510/530/51
CLOSTRIDIUM DIFFICILE INFECTIONInfections and infestations0/1630/1631/1510/510/530/51
DEPRESSIONPsychiatric disorders0/1630/1631/1510/510/530/51
Most frequent other events
Showing 10 of 29
Most frequent other events
EventPlacebo (Period 1)Adalimumab EW (Period 1)Placebo/Placebo (Period 2)Adalimumab EW/Placebo (Period 2)Adalimumab EW/Adalimumab EOW (Period 2)Adalimumab EW/Adalimumab EW (Period 2)
HIDRADENITISSkin and subcutaneous tissue disorders19/1637/16313/15110/518/533/51
HEADACHENervous system disorders21/16321/1634/1514/513/535/51
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations9/1638/16313/1515/514/531/51
DIARRHOEAGastrointestinal disorders4/1639/1632/1511/514/531/51
NASOPHARYNGITISInfections and infestations10/1639/1635/1511/513/533/51
TOOTHACHEGastrointestinal disorders1/1632/1633/1513/510/531/51
BRONCHITISInfections and infestations4/1632/1632/1513/510/531/51
GASTROENTERITIS VIRALInfections and infestations1/1630/1630/1510/512/533/51
INFLUENZAInfections and infestations3/1633/1633/1512/510/533/51
GASTROENTERITISInfections and infestations3/1635/1637/1511/512/531/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboAdalimumab Every Week (EW)Total
Mean36.1 ± 12.1834.9 ± 9.9635.5 ± 11.13
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboAdalimumab Every Week (EW)Total
Female113108221
Male5055105
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, Armstrong AW, Kerdel F, Gold MH, Forman SB, Korman NJ, Giamarellos-Bourboulis EJ, Crowley JJ, Lynde C, Reguiai Z, Prens EP, Alwawi E, Mostafa NM, Pinsky B, Sundaram M, Gu Y, Carlson DM, Jemec GB. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370. PubMed 27518661 ↗
  • Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6. PubMed 29380251 ↗

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01468233
Lead sponsor
AbbVie (prior sponsor, Abbott)
Responsible party
Sponsor
First posted
Nov 9, 2011
Start date
Nov 2011
Primary completion
Apr 2014
Completion
Apr 2014
Results posted
Oct 28, 2015
Last update
Jul 12, 2021

Study contacts

Martin Okun, MD
study chair · AbbVie

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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