Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa
PIONEER II
A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II
2 other identifiers
interventional
326
0 countries
N/A
Brief Summary
A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
October 28, 2015
CompletedJuly 12, 2021
July 1, 2021
2.4 years
November 7, 2011
September 16, 2015
July 8, 2021
Conditions
Keywords
Outcome Measures
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.
Baseline (Week 0) up to Week 12
Secondary Outcomes (3)
Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12
Baseline (Week 0) up to Week 12
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
Baseline (Week 0) up to Week 12
Change From Baseline to Week 12 in Modified Sartorius Score
Baseline (Week 0) and Week 12
Study Arms (6)
Placebo
PLACEBO COMPARATORPlacebo for 12 weeks.
Adalimumab Every Week (EW)
EXPERIMENTALAdalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
Placebo/Placebo
PLACEBO COMPARATORParticipants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).
Adalimumab Every Week (EW)/Placebo
EXPERIMENTALParticipants 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).
Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)
EXPERIMENTALParticipants 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).
Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
EXPERIMENTALParticipants 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).
Interventions
Adalimumab pre-filled syringe, administered by subcutaneous injection
Placebo pre-filled syringe, administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 27518661RESULTKearney N, Chen X, Bi Y, Hew K, Smith KM, Kirby B. Treatment of hidradenitis suppurativa with adalimumab in the PIONEER I and II randomized controlled trials reduced indices of systemic inflammation, recognized risk factors for cardiovascular disease. Clin Exp Dermatol. 2025 Jan 27;50(2):339-347. doi: 10.1093/ced/llae324.
PMID: 39141589DERIVEDRyan 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.
PMID: 29380251DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Information
- Organization
- AbbVie (prior sponsor, Abbott)
Study Officials
- STUDY CHAIR
Martin Okun, MD
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
November 9, 2011
Study Start
November 1, 2011
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
July 12, 2021
Results First Posted
October 28, 2015
Record last verified: 2021-07