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

NCT00918255 | Completed Phase 2 Results

• 2 other identifiers: M10-4672008-004587-38
• Study Type: interventional
• Target: 154
• Locations: 4 countries
• Sites: 26

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Adalimumab; Nodule; Abscess; Fistula; Physicians Global Assessment; Hurley Stage; Sartorius Scale

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16

  Baseline, Week 16

• Percentage of Participants Achieving Clinical Response at Week 2

  Baseline, Week 2

• Percentage of Participants Achieving Clinical Response at Week 4

  Baseline, Week 4

• Percentage of Participants Achieving Clinical Response at Week 8

  Baseline, Week 8

• Percentage of Participants Achieving Clinical Response at Week 12

  Baseline, Week 12

Study Arms (3)

Adalimumab 40 mg qwk

EXPERIMENTAL

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.

Biological: adalimumab

Adalimumab 40 mg eow

EXPERIMENTAL

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.

Biological: adalimumab

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

adalimumab BIOLOGICAL

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

Also known as: ABT-D2E7, Humira

Adalimumab 40 mg eow; Adalimumab 40 mg qwk

Placebo DRUG

Subcutaneous injection using prefilled syringe containing 0.8 milliliters

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (26)

Site Ref # / Investigator 19062

Birmingham, Alabama, 35205, United States

Location

Site Ref # / Investigator 18201

Bakerfield, California, 93309, United States

Location

Site Ref # / Investigator 18467

Los Angeles, California, 90045, United States

Location

Site Ref # / Investigator 18207

San Diego, California, 92103, United States

Location

Site Ref # / Investigator 18204

Miami, Florida, 33136, United States

Location

Site Ref # / Investigator 18209

Atlanta, Georgia, 30327, United States

Location

Site Ref # / Investigator 18202

Skokie, Illinois, 60077, United States

Location

Site Ref # / Investigator 18211

Evansville, Indiana, 47714, United States

Location

Site Ref # / Investigator 18203

Boston, Massachusetts, 02111, United States

Location

Site Ref # / Investigator 18210

Boston, Massachusetts, 02114, United States

Location

Site Ref # / Investigator 18461

St Louis, Missouri, 63104, United States

Location

Site Ref # / Investigator 18466

Omaha, Nebraska, 68144, United States

Location

Site Ref # / Investigator 19141

New York, New York, 10016, United States

Location

Site Ref # / Investigator 18208

New York, New York, 10019, United States

Location

Site Ref # / Investigator 19001

Winston-Salem, North Carolina, 27103, United States

Location

Site Ref # / Investigator 18981

Hershey, Pennsylvania, 17033, United States

Location

Site Ref # / Investigator 18464

Philadelphia, Pennsylvania, 19104, United States

Location

Site Ref # / Investigator 19061

Dallas, Texas, 75246-1613, United States

Location

Site Ref # / Investigator 18463

San Antonio, Texas, 78258, United States

Location

Site Ref # / Investigator 18206

Norfolk, Virginia, 23507, United States

Location

Site Ref # / Investigator 18683

Copenhagen NV, 2400, Denmark

Location

Site Ref # / Investigator 18684

Roskilde, 4000, Denmark

Location

Site Ref # / Investigator 18471

Dessau, 06847, Germany

Location

Site Ref # / Investigator 18469

Kiel, 24105, Germany

Location

Site Ref # / Investigator 18470

Amsterdam, 1105 AZ, Netherlands

Location

Site Ref # / Investigator 18468

Rotterdam, 3015 CA, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 29380251 DERIVED

• 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.

  PMID: 27136622 DERIVED

• 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.

  PMID: 23247938 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa; Abscess; Fistula

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Martin Okun, MD, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: June 11, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 9, 2011
• Results First Posted: May 9, 2011

Record last verified: 2011-04

Locations

US (20); DK (2); DE (2); NL (2)