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

NCT ID: NCT00918255

Last Updated: 2011-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-11-30

Brief Summary

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

Detailed 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.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Adalimumab 40 mg qwk

Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

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

Adalimumab 40 mg eow

Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

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

Placebo

Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous injection using prefilled syringe containing 0.8 milliliters

Interventions

adalimumab

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

Intervention Type: BIOLOGICAL

Placebo

Subcutaneous injection using prefilled syringe containing 0.8 milliliters

Intervention Type: DRUG

Other Intervention Names

ABT-D2E7; Humira

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Principal Investigators

Martin Okun, MD, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Ref # / Investigator 19062

Birmingham, Alabama, United States

Site Ref # / Investigator 18201

Bakerfield, California, United States

Site Ref # / Investigator 18467

Los Angeles, California, United States

Site Ref # / Investigator 18207

San Diego, California, United States

Site Ref # / Investigator 18204

Miami, Florida, United States

Site Ref # / Investigator 18209

Atlanta, Georgia, United States

Site Ref # / Investigator 18202

Skokie, Illinois, United States

Site Ref # / Investigator 18211

Evansville, Indiana, United States

Site Ref # / Investigator 18203

Boston, Massachusetts, United States

Site Ref # / Investigator 18210

Boston, Massachusetts, United States

Site Ref # / Investigator 18461

St Louis, Missouri, United States

Site Ref # / Investigator 18466

Omaha, Nebraska, United States

Site Ref # / Investigator 19141

New York, New York, United States

Site Ref # / Investigator 18208

New York, New York, United States

Site Ref # / Investigator 19001

Winston-Salem, North Carolina, United States

Site Ref # / Investigator 18981

Hershey, Pennsylvania, United States

Site Ref # / Investigator 18464

Philadelphia, Pennsylvania, United States

Site Ref # / Investigator 19061

Dallas, Texas, United States

Site Ref # / Investigator 18463

San Antonio, Texas, United States

Site Ref # / Investigator 18206

Norfolk, Virginia, United States

Site Ref # / Investigator 18683

Copenhagen NV, , Denmark

Site Ref # / Investigator 18684

Roskilde, , Denmark

Site Ref # / Investigator 18471

Dessau, , Germany

Site Ref # / Investigator 18469

Kiel, , Germany

Site Ref # / Investigator 18470

Amsterdam, , Netherlands

Site Ref # / Investigator 18468

Rotterdam, , Netherlands

Countries

United States; Denmark; Germany; Netherlands

References

Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

Reference Type: DERIVED

PMID: 29380251 (View on PubMed)

Scheinfeld N, Sundaram M, Teixeira H, Gu Y, Okun M. Reduction in pain scores and improvement in depressive symptoms in patients with hidradenitis suppurativa treated with adalimumab in a phase 2, randomized, placebo-controlled trial. Dermatol Online J. 2016 Mar 16;22(3):13030/qt38x5922j.

Reference Type: DERIVED

PMID: 27136622 (View on PubMed)

Kimball AB, Kerdel F, Adams D, Mrowietz U, Gelfand JM, Gniadecki R, Prens EP, Schlessinger J, Zouboulis CC, van der Zee HH, Rosenfeld M, Mulani P, Gu Y, Paulson S, Okun M, Jemec GB. Adalimumab for the treatment of moderate to severe Hidradenitis suppurativa: a parallel randomized trial. Ann Intern Med. 2012 Dec 18;157(12):846-55. doi: 10.7326/0003-4819-157-12-201212180-00004.

Reference Type: DERIVED

PMID: 23247938 (View on PubMed)

Other Identifiers

2008-004587-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-467

Identifier Type: -

Identifier Source: org_study_id