Collecting real-world data on secukinumab for treating hidradenitis suppurativa in adults

Prospective, Observational, 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) in Routine Clinical Practice in the Russian Federation (ANIMA-R)

This study is trying to see how well secukinumab works for adults with moderate to severe hidradenitis suppurativa in real-life settings.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: secukinumab
• Locations: 11 sites (Izhevsk and 10 other locations)
• Trial ID: NCT06517732 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world data on the effectiveness of secukinumab in adult patients with moderate to severe hidradenitis suppurativa (HS). It will involve multiple centers across the Russian Federation, where data will be collected from patients who have recently initiated treatment with secukinumab. The attending physician will prescribe secukinumab based on standard clinical guidelines, ensuring that the study reflects routine clinical practice. The study will track patient outcomes and treatment patterns over time.

Who should consider this trial

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

Not a fit: Patients with severe hypersensitivity to secukinumab or those with active inflammatory bowel disease 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 patients with hidradenitis suppurativa.

How similar studies have performed: While this approach is observational and focuses on real-world data, similar studies have shown success in assessing treatment patterns and effectiveness in other conditions.

Eligibility criteria

Inclusion Criteria:

1. Patients who provide written informed consent form (ICF) to participate in the study.
2. Male and female.
3. ≥ 18 years old.
4. Diagnosis of moderate or severe HS (Hurley stage and IHS4).
5. Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
6. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation.

Exclusion Criteria:

1. Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
2. Participation in an ongoing clinical trial.
3. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
4. Clinically significant infection exacerbation, including active tuberculosis.
5. Patients with active inflammatory bowel disease (IBD).
6. Age \<18 years.
7. Pregnancy and breastfeeding.
8. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.

Where this trial is running

Izhevsk and 10 other locations

• Novartis Investigative Site — Izhevsk, Russian Federation (Recruiting)
• Novartis Investigative Site — Kazan, Russian Federation (Recruiting)
• Novartis Investigative Site — Kemerovo, Russian Federation (Recruiting)
• Novartis Investigative Site — Moscow, Russian Federation (Recruiting)
• Novartis Investigative Site — Moscow, Russian Federation (Recruiting)
• Novartis Investigative Site — Moscow, Russian Federation (Recruiting)
• Novartis Investigative Site — Nizhniy Novgorod, Russian Federation (Recruiting)
• Novartis Investigative Site — Saint Petersburg, Russian Federation (Recruiting)
• Novartis Investigative Site — Samara, Russian Federation (Recruiting)
• Novartis Investigative Site — Stavropol, Russian Federation (Recruiting)
• Novartis Investigative Site — Tula, Russian Federation (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Hidradenitis Suppurativa; HS; real-world data; secukinumab