Understanding how Hidradenitis Suppurativa symptoms change after starting secukinumab
Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation: a French Multicentric Prospective Observational Study
Novartis · NCT06444087
This study is tracking how symptoms of Hidradenitis Suppurativa change over a year after starting a new treatment called secukinumab to see how well it works for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 177 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Novartis (industry) |
| Drugs / interventions | secukinumab |
| Locations | 20 sites (Antony and 19 other locations) |
| Trial ID | NCT06444087 on ClinicalTrials.gov |
What this trial studies
This observational study aims to track the changes in symptoms of Hidradenitis Suppurativa (HS) over a 12-month period following the initiation of secukinumab treatment. Conducted across multiple centers in France, it involves the collection of patient-reported outcomes regarding pain, oozing, and odor associated with HS. The study does not alter the standard physician-patient relationship or treatment protocols, allowing physicians to make independent decisions regarding patient care. Patients will be followed for up to 24 months to assess the long-term effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a clinically confirmed diagnosis of Hidradenitis Suppurativa who are starting secukinumab treatment.
Not a fit: Patients with medical or psychological conditions that may hinder their participation or those currently involved in another clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of secukinumab for managing Hidradenitis Suppurativa symptoms.
How similar studies have performed: While this study is observational and builds on existing knowledge, similar studies have shown promising results in understanding treatment impacts for chronic conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Antony and 19 other locations
- Novartis Investigative Site — Antony, France (RECRUITING)
- Novartis Investigative Site — Bordeaux Cedex, France (RECRUITING)
- Novartis Investigative Site — Brest, France (RECRUITING)
- Novartis Investigative Site — Calais, France (RECRUITING)
- Novartis Investigative Site — Dijon, France (RECRUITING)
- Novartis Investigative Site — La Rochelle, France (RECRUITING)
- Novartis Investigative Site — Le Mans, France (RECRUITING)
- Novartis Investigative Site — Lille, France (RECRUITING)
- Novartis Investigative Site — Lorient, France (RECRUITING)
- Novartis Investigative Site — Lyon, France (RECRUITING)
- Novartis Investigative Site — Montpellier, France (RECRUITING)
- Novartis Investigative Site — Nantes Cedex 1, France (RECRUITING)
- Novartis Investigative Site — Nice, France (RECRUITING)
- Novartis Investigative Site — Paris, France (RECRUITING)
- Novartis Investigative Site — Rodez, France (RECRUITING)
- Novartis Investigative Site — Rouen, France (RECRUITING)
- Novartis Investigative Site — Saint Mande, France (RECRUITING)
- Novartis Investigative Site — Saint Pierre, France (RECRUITING)
- Novartis Investigative Site — Toulouse, France (RECRUITING)
- Novartis Investigative Site — Vannes, France (RECRUITING)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hidradenitis Suppurativa, secukinumab, HS, NIS, France