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NCT Number: NCT01704534

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

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

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Centre Groningen

Groningen, 9700RB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ustekinumab

Drug

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

Other names: Stelara

Primary outcomes

  1. Change in Sartorius score

    Time frame: 76 weeks

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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Janssen-Cilag B.V.

Registry information

Official study title

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

Acronym: HiTS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2012
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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