Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01468233
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 3
Start date November 2011
Completion date April 2014

See also
  Status Clinical Trial Phase
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Completed NCT02896920 - Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness
Completed NCT01468207 - Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa Phase 3
Completed NCT03894956 - Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
Completed NCT03001115 - Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects
Not yet recruiting NCT05723757 - Autophagy Dysfunction in Hidradenitis Suppurativa N/A
Completed NCT02808975 - Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically Phase 4
Completed NCT04430855 - A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms Phase 2
Recruiting NCT06212999 - A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa Phase 3
Active, not recruiting NCT04354012 - Hidradenitis Suppurativa Wound Care Phase 2
Completed NCT03487276 - Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Recruiting NCT05620836 - A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 3
Not yet recruiting NCT05735925 - The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis N/A
Recruiting NCT05620823 - A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa Phase 3
Not yet recruiting NCT06241573 - A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab Phase 2/Phase 3
Available NCT05583604 - Secukinumab Global MAP Cohort for Adult Patients With Hidradenitis Suppurativa (HS)