Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918255
• Other study ID #: M10-467
• Secondary ID: 2008-004587-38
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2009
• Last updated: April 14, 2011
• Start date: April 2009
• Est. completion date: November 2010

Study information

• Verified date: April 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Paul-Ehrlich-InstitutNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.

Description:

This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0 through the end of Week 15) followed by a 36-week open-label period (Period 2: Weeks 16 through 52). Participants are randomized in a 1:1:1 ratio based on Hurley Stage as stratification factor to receive adalimumab 40 mg every week (qwk), adalimumab 40 mg every other week (eow), or matching placebo during Period 1. During Period 2, participants receive open-label adalimumab 40 mg eow with the option to escalate to 40 mg weekly dosing at Week 28 or Week 31 if the participant has a Physician's Global Assessment of moderate disease or worse (score of greater than or equal to 3). The primary objective of the study is to determine the clinical efficacy and safety of participants with moderate to severe chronic hidradenitis suppurativa (HS) after 16 weeks of treatment. The secondary objective is to evaluate the maintenance of efficacy and continued safety of adalimumab for an additional 36 weeks of treatment. (Note: Hurley Stage is a classification system for skin involvement that is largely based on the presence and extent of abscess formation accompanied by scarring and sinus tracts. Hurley Stages are I [abscess formation without scarring and sinus tracts], II [widely separated recurrent abscesses with scarring and sinus tracts], and III [multiple interconnected abscesses and sinus tracts across entire area]. Randomization in this study was performed using stratification by Hurley Stage [III versus (I or II).) At the present time, Period 1 double-blind data only is provided; additional information will be provided when analysis of open-label Period 2 is completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with stable, moderate to severe hidradenitis suppurativa

• Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy.

• Ability to administer subcutaneous injections

• General good health otherwise

Exclusion Criteria:

• Prior anti-TNF therapy

• Unstable antibiotic therapy for HS

• Required medication washouts for other HS treatments

• Prior exposure to Tysabri® (natalizumab);

• Recent infection requiring treatment

• Significant medical events or conditions that may put patients at risk for participation

• Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;

• History of cancer, except successfully treated skin cancer

• Recent history of drug or alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Biological:
• adalimumab
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters

Drug:
• Placebo
Subcutaneous injection using prefilled syringe containing 0.8 milliliters

Locations

Country	Name	City	State
Denmark	Site Ref # / Investigator 18683	Copenhagen NV
Denmark	Site Ref # / Investigator 18684	Roskilde
Germany	Site Ref # / Investigator 18471	Dessau
Germany	Site Ref # / Investigator 18469	Kiel
Netherlands	Site Ref # / Investigator 18470	Amsterdam
Netherlands	Site Ref # / Investigator 18468	Rotterdam
United States	Site Ref # / Investigator 18209	Atlanta	Georgia
United States	Site Ref # / Investigator 18201	Bakerfield	California
United States	Site Ref # / Investigator 19062	Birmingham	Alabama
United States	Site Ref # / Investigator 18203	Boston	Massachusetts
United States	Site Ref # / Investigator 18210	Boston	Massachusetts
United States	Site Ref # / Investigator 19061	Dallas	Texas
United States	Site Ref # / Investigator 18211	Evansville	Indiana
United States	Site Ref # / Investigator 18981	Hershey	Pennsylvania
United States	Site Ref # / Investigator 18467	Los Angeles	California
United States	Site Ref # / Investigator 18204	Miami	Florida
United States	Site Ref # / Investigator 18208	New York	New York
United States	Site Ref # / Investigator 19141	New York	New York
United States	Site Ref # / Investigator 18206	Norfolk	Virginia
United States	Site Ref # / Investigator 18466	Omaha	Nebraska
United States	Site Ref # / Investigator 18464	Philadelphia	Pennsylvania
United States	Site Ref # / Investigator 18463	San Antonio	Texas
United States	Site Ref # / Investigator 18207	San Diego	California
United States	Site Ref # / Investigator 18202	Skokie	Illinois
United States	Site Ref # / Investigator 18461	St Louis	Missouri
United States	Site Ref # / Investigator 19001	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Denmark,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Clinical Response at Week 16	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).	Baseline, Week 16	No
Secondary	Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16	Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.	Baseline, Week 16	No
Secondary	Percentage of Participants Achieving Clinical Response at Week 2	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).	Baseline, Week 2	No
Secondary	Percentage of Participants Achieving Clinical Response at Week 4	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).	Baseline, Week 4	No
Secondary	Percentage of Participants Achieving Clinical Response at Week 8	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).	Baseline, Week 8	No
Secondary	Percentage of Participants Achieving Clinical Response at Week 12	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).	Baseline, Week 12	No
Secondary	Change From Baseline in Modified Sartorius Scale at Week 16	The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.	Baseline, Week 16	No
Secondary	Change From Baseline in Modified Sartorius Scale at Week 52	The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.	Baseline, Week 52	No
Secondary	Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52	Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.	Baseline, Week 52	No