Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 99 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: patients, being treated for HS with secukinumab according to the summary of product characteristics (SmPC), after the approval of secukinumab has been granted in this indication.

Trial locations and contacts

80 sites in 1 country.

About this study

Official title: Long Term observAtional, Prospective, Multicenter Study to Collect iN a Real-world populatIon Data on the treatMent Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) (ANIMA)

Conditions

Hidradenitis Suppurativa

Being tested

secukinumab

Keywords

Hidradenitis suppurativa, HS, secukinumab, Germany, NIS

Medical subject headings

Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• secukinumabOther

  Prospective observational study. There is no treatment allocation. Patients administered secukinumab by prescription and administered according to the SmPC.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Proportion of patients receiving up-titration

   Proportion of patients receiving up-titration (q4w-to-q2w)

   Measured: Up to 24 months

2. Proportion of patients receiving down-titration

   Proportion of patients receiving down-titration (q2w-to-q4w)

   Measured: Up to 24 months

3. Time to up-titration and down-titration

   Time to up-titration and down-titration

   Measured: Up to 2 years

4. Duration of q4w treatment with secukinumab after dose reduction

   Duration of q4w treatment with secukinumab after dose reduction

   Measured: Up to 2 years

5. Proportion of patients who receive more than one up-and/or down titration

   Proportion of patients who receive more than one up-and/or down titration

   Measured: Up to 24 months

6. Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab

   Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab

   Measured: Up to 2 years

7. Number and type of surgical interventions

   Number and type of surgical interventions

   • minor and major surgical excision;
   • inpatient, outpatient

   Measured: Up to 2 years

8. Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)

   The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity.

   HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS

   Measured: Up to 24 months

9. mean change of International Hidradenitis Suppurativa Severity Score System (IHS4)

   The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity.

   HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS

   Measured: Up to 24 months

10. Proportion of patients achieving a 5-point reduction of their Dermatology Life Quality Index (DLQI) questionnaire

    The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school.

    Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.

    Measured: Up to 24 months

11. Mean reduction of Abscesses and inflammatory nodules (AN) count

    Mean reduction of Abscesses and inflammatory nodules (AN) count

    Measured: Up to 24 months

12. Proportion of patients achieving a 30% reduction of pain Numerical Rating scale 30 (NRS30)

    The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). To assess this, the patient should concentrate on the pain that his/her skin lesions generate. The Patient's Global Assessment of Skin Pain - NRS will be completed by the subject electronically via a web-based application or in paper form.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Jun 2023
2. Study start10 Aug 2023
3. Primary completion31 Mar 2027 (estimated)
4. Study completion31 Mar 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
• More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.