- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01704534
A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa (HiTS)
February 12, 2015 updated by: Barbara Horváth, Principal Investigator, University Medical Center Groningen
A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)
The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.
Study Overview
Detailed Description
An open label prospective study is performed to investigate the effectiveness and safety of ustekinumab in hidradenitis suppurativa.
Twenty patients will be included.
They will receive ustekinumab 45 or 90 mg on weeks 0-4-16-28.
Patients will be followed up untill week 40.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands, 9700RB
- University Medical Centre Groningen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years or older
- Hidradenitis suppurativa Hurley stage II or III
- No response to conventional local and oral antibiotics, or immunnesuppressive medication, or TNF-alpha inhibitors or surgery
- The patient has to be able to complete a dutch questionnaire
- Informed consent must be obtained
Exclusion Criteria:
- Not able to complete a Dutch questionnaire
- Pregnancy or breast feeding
- Active hepatitis B or C infection, HIV or tuberculosis
- Treatment with biologics or other immunosuppressive medicine in the previous 3 months
- Malignancies in the last 10 years with the exception of basal cell carcinoma
- Demyelinating disorders
- Heart failure
- Known allergy to ustekinumab or to its preservatives
- Live vaccins in the next 3 months Sever liver or renal failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ustekinumab
Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28
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subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sartorius score
Time Frame: 76 weeks
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Clinical response is defined as an improvement of the Sartorius score of at least 50%
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76 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Barbara Horváth, MD-PhD, University Medical Center Groningen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
August 7, 2012
First Submitted That Met QC Criteria
October 9, 2012
First Posted (Estimate)
October 11, 2012
Study Record Updates
Last Update Posted (Estimate)
February 13, 2015
Last Update Submitted That Met QC Criteria
February 12, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 662507
- 2011-002091-16 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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