Hidradenitis Suppurativa (HS) Clinical Trial
Official title:
A Phase 4, Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction With Surgery in Subjects With Moderate to Severe Hidradenitis Suppurativa
The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.
This was an interventional, randomized, double-blind (DB), placebo-controlled study. The study duration included a 30-day Screening Period, an initial 12-week DB treatment pre-surgery period (Period A), a 2-week peri-operative period with continuation of weekly DB study drug administration (Period B), and a subsequent 10-week DB treatment post-operative period (Period C). Randomization (in a 1:1 ratio) in Period A was stratified by baseline Hurley Stage (II versus III) and anatomical location of the planned surgical site (i.e., axilla versus inguinal region). The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded. In Period B, the designated surgeon measured and recorded the surface area of the actual surgery, with surgery occurring during Week 13. Surgery and post-operative management (e.g., hospitalization, surgical wound care) was per local practice. No study drug was administered at Week 24, the final study visit. Participants were able to begin commercial product (as prescribed by the participants's physician) after all Week 24 procedures were completed. ;
| 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 |
NCT01468233 -
Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa
|
Phase 3 | |
| 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 |
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)
|