A prospective *proof of concept study* to evaluate the potential efficacy of ustekinumab in patients with moderate to severe hidradenitis suppurativa (acne ectopica)

Phase 2

Completed

• Conditions: hidradenitis suppurativa; acne ectopica; acne inversa; 10040798

• Registration Number: NL-OMON37989
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patient above 18 to 65 years old
Patient with hidradenitis suppurativa Hurley stage II-III
Failure on conventional therapy with topical and oral antibiotics or immunosuppresiva or surgical intervention or on previous TNF alpha therapy (is not obligatory)
Patient has to be able to fill in a dutch formulated questionnaire
Signed informed consent
Women of childbaring age should use contraception

Exclusion Criteria

Patients unable to fill in the questionnaires (mentally or physically)
Pregnancy or breast feeding patients
Patients with an active (chronic) infection, e.g. hepatitis B or C, HIV, tuberculosis
History of malignancy in past 10 years, except a basal cell carcinoma
Patients with demyelinating disease
Heartfailure NYHA class III-IV
Patients with a known allergy/hypersensitivity reaction to ustekinumab or one of the preservatives
Vaccination with living virus/bacterium < 3 months before starting ustekinumab
Severe liver or kidney dysfunction > 1.5 times of the maximum allowable value

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters:<br /><br>• Number of patients with a clinical response to ustekinimab using the<br /><br>Sartorius/HS-LASI score. Clinical response is defined as >50% improvement at<br /><br>week 40.<br /><br>• Number of patients with a clinical response to ustekinimab using the PGA.<br /><br>Clinical response is defined as a score of 0 (no disease activity) or 1 (mild<br /><br>disease activity).<br /><br>• Number of patients with improved quality of life using the DLQI questionnaire<br /><br>and improvement in pain score using the VAS. A meaningfull improvement is<br /><br>defined as an improvement of the DLQI with at least 5 points and at least 50%<br /><br>improvement on the VAS. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The correlation between serum Interleukine 2 Receptor (sIL2R) and HS disease<br /><br>activity measured by means of the Sartorius/HS-LASI score, PGA and CRP.<br /><br>• The mean reduction in the serum inflammation parameter (CRP).<br /><br>• The mean improvement of Skindex-29.<br /><br>• Description of the histopathological characteristics of HS and the<br /><br>histopathological differences before and after treatment by means of skin<br /><br>biopsies. To evaluate if we can find an explanation for the cause of HS at RNA<br /><br>levels.<br /><br>• The percentual difference in clinical response between patients who have been<br /><br>treated before with biologics (TNF-a non-responders) and patients who have<br /><br>never been treated with biologics (bio-naive patients). </p><br>