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
• 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
• 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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

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