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

University Medical Center Groningen (UMCG)

Status and phase

Completed

Phase 2

Conditions

Hidradenitis Suppurativa

Treatments

Drug: Ustekinumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01704534

662507

2011-002091-16 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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