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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


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
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