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.

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)

ClinicalTrials.gov ID

NCT05921994

Acronym / sponsor ID

ANIMA / CAIN457MDE01

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa, HS, secukinumab, Germany, NIS

Study type

Observational

Recruitment status

Active, not recruiting

Enrolment

436 participants (actual)

Lead sponsor

Novartis PharmaceuticalsIndustry (pharma, biotech, devices)

Study start

10 Aug 2023 (actual)

Primary completion

31 Mar 2027 (estimated)

Study completion

31 Mar 2027 (estimated)

First posted

28 Jun 2023 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 to 99 years

Sex

All

Healthy volunteers

Not accepted

Age groups

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Proportion of patients receiving up-titration

   Time frame: Up to 24 months

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

2. Proportion of patients receiving down-titration

   Time frame: Up to 24 months

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

3. Time to up-titration and down-titration

   Time frame: Up to 2 years

   Time to up-titration and down-titration

4. Duration of q4w treatment with secukinumab after dose reduction

   Time frame: Up to 2 years

   Duration of q4w treatment with secukinumab after dose reduction

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

   Time frame: Up to 24 months

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

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

   Time frame: Up to 2 years

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

7. Number and type of surgical interventions

   Time frame: Up to 2 years

   Number and type of surgical interventions * minor and major surgical excision; * inpatient, outpatient

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

   Time frame: Up to 24 months

   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

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

   Time frame: Up to 24 months

   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

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

    Time frame: Up to 24 months

    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.

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

    Time frame: Up to 24 months

    Mean reduction of Abscesses and inflammatory nodules (AN) count

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

    Time frame: Up to 24 months

    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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

80 sites in 1 country: see every site and its status.