ANIMA: 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.

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05921994

Collaborator

(none)

600

Enrollment

40.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this observational, prospective, non-interventional, multicenter, open-label, single arm study in Hidradenitis suppurativa (HS) is to assess the treatment pattern of secukinumab in a flexible dosing regimen and decision influencing factors for flexible dosing in a real-world population over 2 years.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa	Other: secukinumab

Detailed Description

The study will collect data from patients during routine secukinumab treatment and will be representative of the real-world patient population eligible for secukinumab treatment in Germany.

In order to attain widespread representation of health care practices related to the use of secukinumab in the approved indication of moderate to severe HS, a broad spectrum of dermatology practices and clinics who are treating patients with HS across Germany will be included.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Anticipated Study Start Date :

Jul 31, 2023

Anticipated Primary Completion Date :

Dec 22, 2026

Anticipated Study Completion Date :

Dec 22, 2026

Arms and Interventions

Arm	Intervention/Treatment
secukinumab 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.	Other: secukinumab Prospective observational study. There is no treatment allocation. Patients administered secukinumab by prescription and administered according to the SmPC.

Arm

Intervention/Treatment

secukinumab

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.

Other: secukinumab

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

Outcome Measures

Primary Outcome Measures

Proportion of patients receiving up-titration [Up to 24 months]
Proportion of patients receiving up-titration (q4w-to-q2w)
Proportion of patients receiving down-titration [Up to 24 months]
Proportion of patients receiving down-titration (q2w-to-q4w)
Time to up-titration and down-titration [Up to 2 years]
Time to up-titration and down-titration
Duration of q4w treatment with secukinumab after dose reduction [Up to 2 years]
Duration of q4w treatment with secukinumab after dose reduction
Proportion of patients who receive more than one up-and/or down titration [Up to 24 months]
Proportion of patients who receive more than one up-and/or down titration
Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab [Up to 2 years]
Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab
Number and type of surgical interventions [Up to 2 years]
Number and type of surgical interventions minor and major surgical excision; inpatient, outpatient
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) [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
mean change of International Hidradenitis Suppurativa Severity Score System (IHS4) [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
Proportion of patients achieving a 5-point reduction of their Dermatology Life Quality Index (DLQI) questionnaire [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.
Mean reduction of Abscesses and inflammatory nodules (AN) count [Up to 24 months]
Mean reduction of Abscesses and inflammatory nodules (AN) count
Proportion of patients achieving a 30% reduction of pain Numerical Rating scale 30 (NRS30) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:

Patients who provide written informed consent to participate in the study
Male and female patients with ≥18 years of age
Diagnosis of clinically unequivocal moderate to severe HS
Patients for whom a therapy with secukinumab is medically indicated
Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
Treatment with secukinumab according to the latest version of SmPC
Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit

Exclusion Criteria:

Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients:

Patients who have any contraindications, such as a history of or active inflammatory bowel disease (Crohn´s disease, ulcerative colitis), and are not eligible for treatment with secukinumab according to the SmPC
Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation
Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab
Previous exposure to IL-17 inhibitors
For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors