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

University Medical Center Groningen20 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

UstekinumabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Centre Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

Change in Sartorius score

Clinical response is defined as an improvement of the Sartorius score of at least 50%

Time frame: 76 weeks

Data from ClinicalTrials.gov

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