Hidradenitis SuppurativaPhase 2NCT00918255
Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
A Phase 2 study testing adalimumab in people with Hidradenitis Suppurativa, run by Abbott at 26 sites in 4 countries.
Trial summary
This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 26 sitesin 4 countries
- Study dates
- Apr 2009to Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
United States20 sites
Site Ref # / Investigator 18209
Atlanta, Georgia, 30327
Site Ref # / Investigator 18201
Bakerfield, California, 93309
Site Ref # / Investigator 19062
Birmingham, Alabama, 35205
Site Ref # / Investigator 18203
Boston, Massachusetts, 02111
Site Ref # / Investigator 18210
Boston, Massachusetts, 02114
Site Ref # / Investigator 19061
Dallas, Texas, 75246-1613
Site Ref # / Investigator 18211
Evansville, Indiana, 47714
Site Ref # / Investigator 18981
Hershey, Pennsylvania, 17033
Site Ref # / Investigator 18467
Los Angeles, California, 90045
Site Ref # / Investigator 18204
Miami, Florida, 33136
Site Ref # / Investigator 19141
New York, New York, 10016
Site Ref # / Investigator 18208
New York, New York, 10019
Site Ref # / Investigator 18206
Norfolk, Virginia, 23507
Site Ref # / Investigator 18466
Omaha, Nebraska, 68144
Site Ref # / Investigator 18464
Philadelphia, Pennsylvania, 19104
Site Ref # / Investigator 18463
San Antonio, Texas, 78258
Site Ref # / Investigator 18207
San Diego, California, 92103
Site Ref # / Investigator 18202
Skokie, Illinois, 60077
Site Ref # / Investigator 18461
St Louis, Missouri, 63104
Site Ref # / Investigator 19001
Winston-Salem, North Carolina, 27103
Denmark2 sites
Site Ref # / Investigator 18683
Copenhagen NV, 2400
Site Ref # / Investigator 18684
Roskilde, 4000
Germany2 sites
Site Ref # / Investigator 18471
Dessau, 06847
Site Ref # / Investigator 18469
Kiel, 24105
Netherlands2 sites
Site Ref # / Investigator 18470
Amsterdam, 1105 AZ
Site Ref # / Investigator 18468
Rotterdam, 3015 CA
About this study
Official title: A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.
Read the 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
- Being tested
- adalimumab, Placebo
- Keywords
- Hidradenitis Suppurativa, Adalimumab, Nodule, Abscess, Fistula, Physicians Global Assessment, Hurley Stage, Sartorius Scale
- Medical subject headings
- Hidradenitis Suppurativa, Abscess, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabBiological
Also called ABT-D2E7, Humira
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
PlaceboDrug
Subcutaneous injection using prefilled syringe containing 0.8 milliliters
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: adalimumab |
| Placebo | Placebo comparator | Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 16
Secondary outcomes (8)
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.
Measured: Baseline, Week 16
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).
Measured: Baseline, Week 2
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 8
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).
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 16
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.
Measured: Baseline, Week 52
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.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Okun, MD, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918255
- Sponsor's protocol ID
- M10-467
- Other IDs
- 2008-004587-38, 2008
- Status last verified
- Apr 2011
- First submitted
- 30 Apr 2009
- Last updated
- 9 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29380251Scheinfeld 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.
PubMed 27136622Kimball 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.
PubMed 23247938
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT00918255
- Acronym / sponsor ID
- M10-467
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Adalimumab, Nodule, Abscess, Fistula, Physicians Global Assessment, Hurley Stage, Sartorius Scale
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 9 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adalimumab 40 mg qwk | Experimental | Biological: adalimumabInitial 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. |
| Adalimumab 40 mg eow | Experimental | Biological: adalimumabInitial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo for adalimumab, administered weekly starting at Week 0 through Week 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumabAlso: ABT-D2E7, HumiraSubcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters | Biological | Adalimumab 40 mg eow, Adalimumab 40 mg qwk |
| PlaceboSubcutaneous injection using prefilled syringe containing 0.8 milliliters | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving Clinical Response at Week 16
Time frame: Baseline, 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).
8 secondary outcomes
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Achieving Clinical Response at Week 2
Time frame: Baseline, Week 2
Percentage of Participants Achieving Clinical Response at Week 4
Time frame: Baseline, Week 4
Percentage of Participants Achieving Clinical Response at Week 8
Time frame: Baseline, Week 8
Percentage of Participants Achieving Clinical Response at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Modified Sartorius Scale at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Modified Sartorius Scale at Week 52
Time frame: Baseline, Week 52
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29380251Ryan 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.
- Derived from this study: PubMed 27136622Scheinfeld 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.
- Derived from this study: PubMed 23247938Kimball 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Okun, MD, PhD study director
Abbott
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adalimumab in people with Hidradenitis Suppurativa, run by Abbott at 26 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Denmark, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Clinical Response at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00918255, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2011; AzTrials last refreshed its copy on 7 Nov 2026.