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

This study is currently recruiting participants.
Verified October 2012 by University Medical Centre Groningen
Sponsor:
Collaborator:
Janssen-Cilag B.V.
Information provided by (Responsible Party):
Barbara Horváth, Principal Investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01704534
First received: August 7, 2012
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Hidradenitis Suppurativa
 Drug: Ustekinumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Drug Information available for: Ustekinumab
U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Change in Sartorius score [ Time Frame: 76 weeks ] [ Designated as safety issue: No ]
    Clinical response is defined as an improvement of the Sartorius score of at least 50%


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ustekinumab Drug: Ustekinumab
subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28
Other Name: Stelara

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704534

Locations
Netherlands
University Medical Centre Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: Barbara Horváth, MD PhD     0031503612520     b.horvath@umcg.nl    
Contact: Janine L Blok, MD     0031503612520     j.l.blok@umcg.nl    
Principal Investigator: Barbara Horváth, MD PhD            
Sub-Investigator: Janine L Blok, MD            
Sponsors and Collaborators
University Medical Centre Groningen
Janssen-Cilag B.V.
Investigators
Principal Investigator: Barbara Horváth, MD-PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: Barbara Horváth, Principal Investigator, MD PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01704534     History of Changes
Other Study ID Numbers: 662507, 2011-002091-16
Study First Received: August 7, 2012
Last Updated: October 9, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Hidradenitis suppurativa
Acne ectopica
Inverse acne
Ustekinumab
Stelara

Additional relevant MeSH terms:
Sweat Gland Diseases
Hidradenitis
Hidradenitis Suppurativa
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
 Infection
Suppuration
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013