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NCT01704534 Clinical Trial

A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

— HiTS  

Official title:
A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01704534
Other study ID # 662507
Secondary ID 2011-002091-16
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2012
Est. completion date April 2014

Study information
Verified date April 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ustekinumab
subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28

Locations
Country Name City State
Netherlands University Medical Centre Groningen Groningen

Sponsors (2)
Lead Sponsor Collaborator
University Medical Center Groningen Janssen-Cilag B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Sartorius score Clinical response is defined as an improvement of the Sartorius score of at least 50% 76 weeks
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