Hidradenitis SuppurativaPhase 1NCT00134134
Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
A Phase 1 study testing efalizumab in people with Hidradenitis Suppurativa, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness and safety of efalizumab in treating hydradenitis suppurativa, and to evaluate the duration of the benefit seen in people who respond to treatment with efalizumab, after the medication is stopped. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- efalizumab
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Aug 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female between 18-65 years of age
- Has Hydradenitis Suppurativa (HS) involving at least 1 area of the body with greater than or equal to 12 lesions; onset of disease is 6 months and greater.
- Failed at least 3 months of standard conventional therapies such as antibiotics and/or systemic retinoids
- Willing to use contraception unless not of childbearing potential
- Able to comply with protocol requirements
Who cannot join
- Received within 4 weeks prior immunosuppressive medication
- Received treatment within 3 months prior with systemic retinoids (acitretin or isotretinoin)
- Received high potency (class I or II) topical corticoid steroids, topical antibiotics, systemic antibiotics, or topical immunomodulators (tacrolimus or pimecrolimus) within 2 weeks prior to baseline visit
- Received intralesional injections of corticosteroids within 4 weeks prior
- Received surgical intervention for the treatment of HS
- Known history of HIV seropositivity
Show all 16Show fewer
- History of untreated or active tuberculosis
- Active infection requiring systemic antibiotics within 4 weeks of baseline visit
- History of recurrent/chronic infections
- History of malignancy within 5 years of baseline visit (except for squamous cell carcinoma or basal cell carcinoma; may enroll if treated and assessed as cured).
- Pregnant or breastfeeding
- Immunocompromised due to a medical condition
- Has any significant laboratory abnormalities
- Has any medical condition that may interfere with evaluation of the safety and efficacy of efalizumab
- Received efalizumab or any other biologic within the last 6 months
- Taken or used any investigational drug or device within 30 days prior
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine, Dept of Dermatology
New York, New York, 10016
About this study
Official title: An Open-Label Assessment of the Efficacy & Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
The purpose of this study is to determine the effectiveness and safety of efalizumab in treating hydradenitis suppurativa, and to evaluate the duration of the benefit seen in people who respond to treatment with efalizumab, after the medication is stopped.
Read the detailed description
The primary objective of this study is to assess the efficacy of subcutaneously administered efalizumab in the treatment of refractory, severe hydradenitis suppurativa. The secondary objectives of this study are to assess the ability to re-establish disease control after discontinuation of drug and allowance for relapse of disease, as well as to assess the safety of subcutaneously administered efalizumab in the treatment of refractory, severe hydradenitis suppurativa.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- efalizumab
- Keywords
- hidradenitis suppurativa, efalizumab, biologic, Raptiva
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efalizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number of inflammatory lesions 12 weeks post-baseline
Secondary outcomes (2)
Time to the reduction of lesions during 12 weeks of treatment
Percent of disease activity at various weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startFeb 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Bruce Strober, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134134
- Sponsor's protocol ID
- H12452-01B
- Status last verified
- Sep 2006
- First submitted
- 23 Aug 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Assessment of the Efficacy & Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT00134134
- Acronym / sponsor ID
- H12452-01B
- Conditions
- Hidradenitis Suppurativa
- Keywords
- hidradenitis suppurativa, efalizumab, biologic, Raptiva
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Feb 2005
- Study completion
- Aug 2006
- First posted
- 24 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness and safety of efalizumab in treating hydradenitis suppurativa, and to evaluate the duration of the benefit seen in people who respond to treatment with efalizumab, after the medication is stopped.
Detailed description
The primary objective of this study is to assess the efficacy of subcutaneously administered efalizumab in the treatment of refractory, severe hydradenitis suppurativa. The secondary objectives of this study are to assess the ability to re-establish disease control after discontinuation of drug and allowance for relapse of disease, as well as to assess the safety of subcutaneously administered efalizumab in the treatment of refractory, severe hydradenitis suppurativa.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female between 18-65 years of age
- Has Hydradenitis Suppurativa (HS) involving at least 1 area of the body with greater than or equal to 12 lesions; onset of disease is 6 months and greater.
- Failed at least 3 months of standard conventional therapies such as antibiotics and/or systemic retinoids
- Willing to use contraception unless not of childbearing potential
- Able to comply with protocol requirements
Key exclusion criteria (16 listed)
- Received within 4 weeks prior immunosuppressive medication
- Received treatment within 3 months prior with systemic retinoids (acitretin or isotretinoin)
- Received high potency (class I or II) topical corticoid steroids, topical antibiotics, systemic antibiotics, or topical immunomodulators (tacrolimus or pimecrolimus) within 2 weeks prior to baseline visit
- Received intralesional injections of corticosteroids within 4 weeks prior
- Received surgical intervention for the treatment of HS
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 |
|---|---|---|
| efalizumab | Drug | – |
Primary outcome
Reduction in number of inflammatory lesions 12 weeks post-baseline
2 secondary outcomes
Time to the reduction of lesions during 12 weeks of treatment
Percent of disease activity at various weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
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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.
Bruce Strober, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing efalizumab in people with Hidradenitis Suppurativa, run by NYU Langone Health at 1 site in United States.
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 5 inclusion and 16 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 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in number of inflammatory lesions 12 weeks post-baseline. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2006.