Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation

NCT06444087 | Active Not Recruiting

• 1 other identifier: CAIN457MFR01
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 22

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.

Conditions

Hidradenitis Suppurativa

Keywords

secukinumab; Hidradenitis Suppurativa; HS; NIS; France

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving at least 30% reduction of the NRS score for at least one the assessed symptoms

  Patients will provide an assessment of pain, oozing and bad smell based on three numeric rating scales (NRS). The most common form of the scale is a horizontal line with a numeric scale ranging from 0 to 10, 0 corresponding to "no symptoms" and 10 being the worst possible symptom. At each visit, these three assessments will cover the last seven days.

  Baseline, month 12

Secondary Outcomes (20)

• Proportion of patients achieving at least a 30% reduction of NRS

  Baseline, month 3, month 6, month 18 and month 24

• Proportion of patients achieving at least a 5-point reduction of the Dermatology Life Quality Index (DLQI)

  Baseline, month 3, month 6, month 18 and month 24

• 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

  Baseline, up to 24 months

• Proportion of patients having stopped at tobacco, alcohol and cannabis use

  Baseline, month 3, month 6, month 18 and month 24

• Absenteeism due to Hidradenitis Suppurativa

  Baseline, month 3, month 6, month 18 and month 24

Study Arms (1)

secukinumab

Patients prescribed with secukinumab

Other: secukinumab

Interventions

secukinumab OTHER

This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.

secukinumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (22)

Novartis Investigative Site

Nice, France, 06000, France

Location

Novartis Investigative Site

Antony, 92160, France

Location

Novartis Investigative Site

Bordeaux, 33075, France

Location

Novartis Investigative Site

Brest, 29609, France

Location

Novartis Investigative Site

Calais, 62100, France

Location

Novartis Investigative Site

Dijon, 21000, France

Location

Novartis Investigative Site

La Rochelle, 17019, France

Location

Novartis Investigative Site

Le Mans, 72000, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Lorient, 56322, France

Location

Novartis Investigative Site

Lyon, 69003, France

Location

Novartis Investigative Site

Marseille, 13008, France

Location

Novartis Investigative Site

Martigues, 13500, France

Location

Novartis Investigative Site

Montpellier, 34090, France

Location

Novartis Investigative Site

Nantes, 44093, France

Location

Novartis Investigative Site

Paris, 75014, France

Location

Novartis Investigative Site

Rodez, 12000, France

Location

Novartis Investigative Site

Rouen, 76031, France

Location

Novartis Investigative Site

Saint-Mandé, 94160, France

Location

Novartis Investigative Site

Saint-Pierre, 97410, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

Novartis Investigative Site

Vannes, 56000, France

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (22)