Safety and Efficacy of Humira (Adalimumab) for Hidradenitis Suppurativa (HS) Peri-Surgically (SHARPS Study) (SHARPS)
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|ClinicalTrials.gov Identifier: NCT02808975|
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Drug: Adalimumab Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 4, Double-blind, Randomised, 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|
|Actual Study Start Date :||July 18, 2016|
|Estimated Primary Completion Date :||September 18, 2019|
|Estimated Study Completion Date :||September 18, 2019|
Placebo Comparator: Placebo
Participants randomized to the placebo arm will receive placebo.
Weekly subcutaneous injection
Active Comparator: Adalimumab
Participants randomized to the adalimumab arm will receive active drug, adalimumab.
Weekly subcutaneous injection
Other Name: Humira
- Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: At Week 12 ]HiSCR defined as at least a 50% reduction in the AN count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
- Proportion of participants achieving HiSCR-es [ Time Frame: At Weeks 12 and 24 ]The proportion of participants achieving HiSCR-es (defined as the Hidradenitis Suppurativa Clinical Response excluding the HS surgical site)
- Proportion of participants that require less extensive surgery than the surgical plan (determined at Baseline) or no surgery [ Time Frame: At Week 12 ]The proportion of participants that require less extensive surgery than the surgical plan or no longer require surgery.
- Percent change in surface area of the Hidradenitis Suppurativa (HS) surgical site [ Time Frame: From Week 0 to Week 12 ]Assessing change in surface area of the HS surgical site from baseline to week 12, before surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808975
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
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|Study Director:||AbbVie Inc.||AbbVie|