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Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER II)

Primary Purpose

Hidradenitis Suppurativa (HS)

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
adalimumab
placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa (HS) focused on measuring placebo controlled, double blind, adalimumab, TNF, psoriasis, HS, PIONEER II, hidradenitis suppurativa, acne inversa, boil, acne

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).
  • 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Placebo Comparator

    Experimental

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    Adalimumab Every Week (EW)

    Placebo/Placebo

    Adalimumab Every Week (EW)/Placebo

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

    Adalimumab Every Week (EW)/Adalimumab Every Week (EW)

    Arm Description

    Placebo for 12 weeks.

    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).

    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).

    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).

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    November 7, 2011
    Last Updated
    July 8, 2021
    Sponsor
    AbbVie (prior sponsor, Abbott)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01468233
    Brief Title
    Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa
    Acronym
    PIONEER II
    Official Title
    A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie (prior sponsor, Abbott)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hidradenitis Suppurativa (HS)
    Keywords
    placebo controlled, double blind, adalimumab, TNF, psoriasis, HS, PIONEER II, hidradenitis suppurativa, acne inversa, boil, acne

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    326 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo for 12 weeks.
    Arm Title
    Adalimumab Every Week (EW)
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Placebo/Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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).
    Arm Title
    Adalimumab Every Week (EW)/Placebo
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Biological
    Intervention Name(s)
    adalimumab
    Other Intervention Name(s)
    Humira
    Intervention Description
    Adalimumab pre-filled syringe, administered by subcutaneous injection
    Intervention Type
    Biological
    Intervention Name(s)
    placebo
    Intervention Description
    Placebo pre-filled syringe, administered by subcutaneous injection
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
    Description
    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 Outcome Measure Information:
    Title
    Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12
    Description
    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
    Title
    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
    Description
    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
    Title
    Change From Baseline to Week 12 in Modified Sartorius Score
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    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). 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martin Okun, MD
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27518661
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    29380251
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://rxabbvie.com
    Description
    Related Info

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