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

Phase 2

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: Ustekinumab

• Registration Number: NCT01704534
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-11
• Primary Completion: 2014-01
• Study Completion: 2014-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ustekinumab	Ustekinumab	Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28

Primary Outcome Measures

Name	Time	Method
Change in Sartorius score	76 weeks	Clinical response is defined as an improvement of the Sartorius score of at least 50%

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands