Back to results

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

Primary Purpose

Hidradenitis Suppurativa

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Ustekinumab

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis suppurativa, Acne ectopica, Inverse acne, Ustekinumab, Stelara

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Medical Centre Groningen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ustekinumab

Arm Description

Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28

Outcomes

Primary Outcome Measures

Change in Sartorius score

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01704534

First Posted

August 7, 2012

Last Updated

February 12, 2015

Sponsor

University Medical Center Groningen

Collaborators

Janssen-Cilag B.V.

1. Study Identification

Unique Protocol Identification Number

NCT01704534

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Center Groningen

Collaborators

Janssen-Cilag B.V.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hidradenitis Suppurativa

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ustekinumab

Arm Type

Experimental

Arm Description

Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28

Intervention Type

Drug

Intervention Name(s)

Ustekinumab

Other Intervention Name(s)

Stelara

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Sartorius score

Description

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

Time Frame

76 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara Horváth, MD-PhD

Organizational Affiliation

University Medical Center Groningen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Centre Groningen

City

Groningen

ZIP/Postal Code

9700RB

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs