Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER II)
This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01468233
First received: November 7, 2011
Last updated: March 14, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
A study to evaluate the safety and efficacy of treatment in adults with moderate to severe hidradenitis suppurativa.
| Condition | Intervention | Phase |
|---|---|---|
|
Hidradenitis Suppurativa (HS) |
Biological: adalimumab Biological: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Clinical Study Protocol M11-810 - PIONEER II A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa |
Resource links provided by NLM:
Genetics Home Reference related topics:
hidradenitis suppurativa
MedlinePlus related topics:
Hidradenitis Suppurativa
Drug Information available for:
Adalimumab
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Proportion of subjects achieving clinical response at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]Subjects achieving improvement in hidradenitis suppurativa severity.
Secondary Outcome Measures:
- Proportion of subjects achieving counts of 0, 1, or 2 at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]Subjects counts lowered to 0, 1, or 2 at Week 12, among subjects with Hurley Stage II at Baseline
- Reduction in patient skin pain assessment at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]Proportion of subjects who achieve a reduction, and at least 1 unit reduction from baseline in their skin pain at measured by the Patient's Global Assessment of Skin Pain (NRS30) at Week 12
- Change in Sartorius scale [ Time Frame: Baseline (Week 0) and Week 12 ] [ Designated as safety issue: No ]Change in Sartorius scale from Baseline to Week 12
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: adalimumab every week (ew)
adalimumab every week
|
Biological: adalimumab
Prefilled syringe, adalimumab subcutaneous every week
Other Name: Humira
|
|
Placebo Comparator: placebo
placebo
|
Biological: placebo
Prefilled syringe, placebo every week
Other Name: placebo
|
|
Experimental: adalimumab every other week (eow)
adalimumab every other week (eow)
|
Biological: adalimumab
Prefilled syringe, subcutaneous every other week (eow)
Other Name: Humira
|
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 hidradenitis suppurativa (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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults must have a diagnosis of hidradenitis suppurativa (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 count of greater than or equal to 3 at baseline.
Exclusion Criteria:
- Subject was previously treated with adalimumab or another 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468233
Show 42 Study Locations
Contacts
| Contact: Andrea L. Byars, BS | 847-937-7904 | andrea.byars@abbvie.com |
| Contact: Tiffany Askew, BS | 847-937-9399 | tiffany.askew@abbvie.com |
Show 42 Study LocationsSponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Chair: | Martin Okun, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01468233 History of Changes |
| Other Study ID Numbers: | M11-810, 2011-003406-24 |
| Study First Received: | November 7, 2011 |
| Last Updated: | March 14, 2013 |
| Health Authority: | Australia: National Health and Medical Research Council Canada: Health Canada Denmark: The Ministry of the Interior and Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Sweden: Medical Products Agency Switzerland: Ethikkommission Turkey: Ministry of Health United States: Food and Drug Administration Greece: National Organization of Medicines |
Keywords provided by AbbVie:
|
placebo controlled double blind adalimumab TNF psoriasis HS |
PIONEER II hidradenitis suppurativa acne inversa boil acne |
Additional relevant MeSH terms:
|
Hidradenitis Hidradenitis Suppurativa Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Bacterial Infections Skin Diseases, Infectious |
Infection Suppuration Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013