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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37989

Enrollment

Registered

2011-09-26

Start date

2012-05-29

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

hidradenitis suppurativa

Interventions

patients 100 kg a 90 mg subcutaneous injection with ustekinumab on week 0-4-16 and 28

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 1.5 times of the maximum allowable value

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

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