To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

— HIDRI2007  

Official title:

Open Label,Phase Two Study to Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827996
• Other study ID #: HIDRI2007
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2009
• Last updated: January 22, 2009
• Start date: February 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2009
• Source: Florida Academic Dermatology Centers
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following:

1. HS >1 year duration with multiple ER or doctors visits related to HS

2. Intralesional kenalog injection >5/year, however none within 2 weeks of entry

3. Failed systemic retinoids, but not within 3 months of entry

4. 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)

5. History of surgery (reconstructive), but not within 3 months of entry

Exclusion Criteria:

1. 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).

2. Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).

3. If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection.

4. Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months.

5. 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.

6. 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.

7. Have a concomitant diagnosis or history of congestive heart failure.

8. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• adalimumab
Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Florida Academic Dermatology Centers	Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		13 weeks	Yes
Secondary	To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa.		13 weeks	Yes
Secondary	To evaluate the ability of adalimumab to maintain suppression of the disease.		13 weeks	Yes