To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa (HIDRI2007)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
The trial is a 12-week phase 2 study. Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12 in subjects with moderate to severe hidradenitis suppurativa.
To assess the efficacy and safety of adalimumab in subjects with moderate to severe hidradenitis suppurativa. Efficacy will be evaluated using the included Hidradenitis Suppurativa Severity Index (HSSI). [ Time Frame: 13 weeks ]
Secondary Outcome Measures :
To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa. [ Time Frame: 13 weeks ]
To evaluate the ability of adalimumab to maintain suppression of the disease. [ Time Frame: 13 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following:
HS >1 year duration with multiple ER or doctors visits related to HS
Intralesional kenalog injection >5/year, however none within 2 weeks of entry
Failed systemic retinoids, but not within 3 months of entry
Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment)
History of surgery (reconstructive), but not within 3 months of entry
Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection).
Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection.
Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
Have a concomitant diagnosis or history of congestive heart failure.
Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.