Clinical trial NCT06444087: Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation
Official title: Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation: a French Multicentric Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hidradenitis Suppurativa
Keywords: secukinumab
Hidradenitis Suppurativa
HS
NIS
France
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include male and female patients (aged ≥ 18 years) with a diagnosis of HS and for whom the decision to initiate treatment with secukinumab was made independently of the study.

Brief summary: The primary objective of this non-interventional study is to describe the evolution of Hidradenitis suppurativa (HS) symptoms 12 months after secukinumab initiation based on the patients' assessment of pain, oozing, and bad smell.

Detailed description: This study is a prospective (primary data), national, descriptive, non-interventional, multicentre study conducted by medical practice and hospital-based dermatologists across different geographical regions in France.

This real-world study does not change the physician-patient relationship or patient management or follow-up. Physicians remain free with their prescriptions and patient follow-up procedures. In fact, secukinumab initiation and all treatment decisions will be made according to routine medical care and independently of study participation.

Recruited patients will be longitudinally followed-up for the duration of the study, up to 24 months (± 3 months) after secukinumab initiation or secukinumab treatment discontinuation before the end of the 24 months of follow-up (early discontinuation).

Eligibility criteria: Inclusion Criteria:

1. Male and female patients ≥ 18 years old,
2. Patients who do not object to participation in the study,
3. Diagnosis of HS clinically confirmed,
4. Initiation of secukinumab treatment for HS in compliance with the summary of product characteristics,
5. The physician's decision to initiate secukinumab has been taken according to his/her own practice and regardless of study participation.

Exclusion Criteria:

1. Patients with any medical or psychological condition which, in the physician's opinion, may prevent participation in the study,
2. Patients participating in a clinical trial.

Primary outcomes:
measure: Proportion of patients achieving at least 30% reduction of the NRS score for at least one the assessed symptoms
timeFrame: Baseline, month 12
Secondary outcomes:
measure: Proportion of patients achieving at least a 30% reduction of NRS
timeFrame: Baseline, month 3, month 6, month 18 and month 24
measure: Proportion of patients achieving at least a 5-point reduction of the Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, month 3, month 6, month 18 and month 24
measure: Proportion of patients maintaining the improvement up to 24 months of the response of the Impact of Hidradenitis Suppurativa on daily life compared to baseline
timeFrame: Baseline, up to 24 months
measure: Proportion of patients having stopped at tobacco, alcohol and cannabis use
timeFrame: Baseline, month 3, month 6, month 18 and month 24
measure: Absenteeism due to Hidradenitis Suppurativa
timeFrame: Baseline, month 3, month 6, month 18 and month 24
measure: Proportion of patients achieving at least a 5-point reduction of FDLQI compared to the baseline
timeFrame: Baseline, month 3, month 6, month 18 and month 24
measure: Secukinumab dose regimen prescribed at baseline
timeFrame: Baseline
measure: Proportion of patients receiving up-titration or down-titration
timeFrame: Month 3, month 6, month 12, month 18 and month 24
measure: Time spent under each treatment regimen
timeFrame: Up to 24 months
measure: Total duration of secukinumab treatment
timeFrame: Up to 24 months
measure: Proportion of patients with at least one temporary discontinuation
timeFrame: Up to 24 months
measure: Proportion of patients taking all prescribed doses
timeFrame: Up to 24 months
measure: Proportion of patients achieving a reduction in IHS4
timeFrame: Baseline, month 3, month 6, month 12, month 18 and month 24
measure: Evolution of AN count
timeFrame: Baseline, month 3, month 6, month 12, month 18 and month 24
measure: Percentages of patients with onset or worsening of flares
timeFrame: Baseline, month 3, month 6, month 18 and month 24
measure: Proportion of patients who achieved at least a 30% reduction in the NRS score (pruritus)
timeFrame: Baseline, month 3, month 6, month 18 and month 24
measure: Proportion of patients receiving at least one medication for HS
timeFrame: Month 3, month 6, month 18 and month 24
measure: Proportion of patients who had a surgical procedure
timeFrame: Up to 24 months
measure: Proportion of patients with stable/increased/decreased dressing used since the baseline visit
timeFrame: Baseline, month 3, month 6, month 18 and month 24
measure: Number of patients by reasons for secukinumab initiation
timeFrame: Baseline
Other outcomes:
Locations:
city: Antony
country: France
facility: Novartis Investigative Site
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Calais
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: La Rochelle
country: France
facility: Novartis Investigative Site
city: Le Mans
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Lorient
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nantes Cedex 1
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Rodez
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint Mande
country: France
facility: Novartis Investigative Site
city: Saint Pierre
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Vannes
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: