Observational study on secukinumab treatment for hidradenitis suppurativa

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)

This study looks at how well secukinumab works for adults with moderate to severe hidradenitis suppurativa by gathering real-world data from different dermatology practices in Germany over two years.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: secukinumab
• Locations: 100 sites (Aachen and 99 other locations)
• Trial ID: NCT05921994 on ClinicalTrials.gov

What this trial studies

This observational, prospective study aims to collect real-world data on the treatment patterns of secukinumab in adult patients with moderate to severe hidradenitis suppurativa (HS) over a two-year period. It will involve multiple dermatology practices across Germany to ensure a broad representation of treatment practices. The study will assess flexible dosing regimens and the factors influencing treatment decisions in a real-world setting, providing insights into the effectiveness and management of HS with secukinumab.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of moderate to severe hidradenitis suppurativa who are eligible for secukinumab treatment.

Not a fit: Patients who do not have a diagnosis of hidradenitis suppurativa or those with contraindications to secukinumab will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of secukinumab's effectiveness and optimize treatment strategies for patients with hidradenitis suppurativa.

How similar studies have performed: Other studies have shown success with similar observational approaches in understanding treatment patterns and outcomes in chronic conditions.

Eligibility criteria

Inclusion Criteria:

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

1. Patients who provide written informed consent to participate in the study
2. Male and female patients with ≥18 years of age
3. Diagnosis of clinically unequivocal moderate to severe HS
4. Patients for whom a therapy with secukinumab is medically indicated
5. Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
6. Treatment with secukinumab according to the latest version of SmPC
7. 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:

1. 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
2. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation
3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab
4. Previous exposure to IL-17 inhibitors
5. For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors

Where this trial is running

Aachen and 99 other locations

• Novartis Investigative Site — Aachen, Germany (Recruiting)
• Novartis Investigative Site — Ahaus, Germany (Recruiting)
• Novartis Investigative Site — Annaberg-Buchholz, Germany (Recruiting)
• Novartis Investigative Site — Augsburg, Germany (Recruiting)
• Novartis Investigative Site — Bad Steben, Germany (Recruiting)
• Novartis Investigative Site — Baden-Baden, Germany (Recruiting)
• Novartis Investigative Site — Bergen, Germany (Recruiting)
• Novartis Investigative Site — Berlin, Germany (Recruiting)
• Novartis Investigative Site — Berlin, Germany (Recruiting)
• Novartis Investigative Site — Berlin, Germany (Recruiting)
• Novartis Investigative Site — Berlin, Germany (Recruiting)
• Novartis Investigative Site — Berlin, Germany (Recruiting)
• Novartis Investigative Site — Bielefeld, Germany (Recruiting)
• Novartis Investigative Site — Bochum, Germany (Recruiting)
• Novartis Investigative Site — Bonn, Germany (Recruiting)
• Novartis Investigative Site — Brandenburg An Der Havel, Germany (Recruiting)
• Novartis Investigative Site — Bremen, Germany (Recruiting)
• Novartis Investigative Site — Bremen, Germany (Completed)
• Novartis Investigative Site — Bueckeburg, Germany (Recruiting)
• Novartis Investigative Site — Buxtehude, Germany (Recruiting)
• Novartis Investigative Site — Chemnitz, Germany (Recruiting)
• Novartis Investigative Site — Chemnitz, Germany (Recruiting)
• Novartis Investigative Site — Delitzsch, Germany (Recruiting)
• Novartis Investigative Site — Dessau Rosslau, Germany (Recruiting)
• Novartis Investigative Site — Dorsten, Germany (Recruiting)
• Novartis Investigative Site — Dortmund, Germany (Recruiting)
• Novartis Investigative Site — Dresden, Germany (Withdrawn)
• Novartis Investigative Site — Dresden, Germany (Recruiting)
• Novartis Investigative Site — Dresden, Germany (Recruiting)
• Novartis Investigative Site — Duren, Germany (Recruiting)
• Novartis Investigative Site — Emsdetten, Germany (Recruiting)
• Novartis Investigative Site — Erlangen, Germany (Recruiting)
• Novartis Investigative Site — Falkenberg, Germany (Recruiting)
• Novartis Investigative Site — Falkensee, Germany (Recruiting)
• Novartis Investigative Site — Freiburg, Germany (Recruiting)
• Novartis Investigative Site — Freising, Germany (Recruiting)
• Novartis Investigative Site — Geilenkirchen, Germany (Recruiting)
• Novartis Investigative Site — Gelsenkirchen, Germany (Recruiting)
• Novartis Investigative Site — Gera, Germany (Recruiting)
• Novartis Investigative Site — Gernsbach, Germany (Recruiting)
• Novartis Investigative Site — Gladbeck, Germany (Recruiting)
• Novartis Investigative Site — Grossenhain, Germany (Recruiting)
• Novartis Investigative Site — Hamburg, Germany (Recruiting)
• Novartis Investigative Site — Hamburg, Germany (Recruiting)
• Novartis Investigative Site — Hamburg, Germany (Recruiting)
• Novartis Investigative Site — Hamburg, Germany (Recruiting)
• Novartis Investigative Site — Hannover, Germany (Recruiting)
• Novartis Investigative Site — Hasfurt, Germany (Recruiting)
• Novartis Investigative Site — Haslach im Kinzigtal, Germany (Recruiting)
• Novartis Investigative Site — Hofgeismar, Germany (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Hidradenitis Suppurativa; Hidradenitis suppurativa; HS; secukinumab; Germany; NIS