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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01704534

Acronym

HiTS

Enrollment

Registered

2012-10-11

Start date

2012-05-31

Completion date

2014-04-30

Last updated

2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa, Acne ectopica, Inverse acne, Ustekinumab, Stelara

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.

Interventions

DRUGUstekinumab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026