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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 : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The objective of this study is to assess the safety and efficacy of adalimumab prior to surgery in subjects with moderate to severe Hidradenitis Suppurativa (HS) who are surgical candidates.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa (HS) Drug: Adalimumab Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants randomized to the placebo arm will receive placebo.
Drug: Placebo
Weekly subcutaneous injection

Active Comparator: Adalimumab
Participants randomized to the adalimumab arm will receive active drug, adalimumab.
Drug: Adalimumab
Weekly subcutaneous injection
Other Name: Humira




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the Baseline visit
  • Participant must have at least 3 distinct anatomical regions involved with inflammatory ( also termed 'active') HS lesions; plus

    • either one axilla or one inguinal region (limited to the inguino-crural fold and adjacent areas) that requires excisional surgery, and
    • with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region) rated as Hurley Stage II or III
  • Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS non-surgical sites
  • The HS surgical site must contain at least one active HS lesion
  • The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon

Exclusion Criteria:

  • Has a draining fistula count of greater than 20 at the Baseline visit
  • Requires surgery at any anatomical site other than an unilateral axilla or inguinal region site
  • Requires surgical management prior to Week 13
  • Requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant

Information from the National Library of Medicine

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


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Show 53 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02808975     History of Changes
Other Study ID Numbers: M15-574
2015-005161-23 ( EudraCT Number )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Hidradenitis Suppurativa
axilla
inguinal region
Hurley Stage I, II, or III
adalimumab
secondary intention
abcess and inflammatory nodule (AN) count

Additional relevant MeSH terms:
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents