Active — Not RecruitingNot Applicable

Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.

Germany434 participantsStarted 2023-08-10

Plain-language summary

The purpose of this observational, prospective, non-interventional, multicenter, open-label, single arm study in Hidradenitis suppurativa (HS) is to assess the treatment pattern of secukinumab in a flexible dosing regimen and decision influencing factors for flexible dosing in a real-world population over 2 years.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients who provide written informed consent to participate in the study
✓. Male and female patients with ≥18 years of age
✓. Diagnosis of clinically unequivocal moderate to severe HS
✓. Patients for whom a therapy with secukinumab is medically indicated
✓. Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
✓. Treatment with secukinumab according to the latest version of SmPC
✓. Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit

Exclusion criteria

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

What they're measuring

Proportion of patients receiving up-titration

Timeframe: Up to 24 months

Proportion of patients receiving down-titration

Timeframe: Up to 24 months

Time to up-titration and down-titration

Timeframe: Up to 2 years

Duration of q4w treatment with secukinumab after dose reduction

Timeframe: Up to 2 years

Proportion of patients who receive more than one up-and/or down titration

Timeframe: Up to 24 months

Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab

Timeframe: Up to 2 years

Number and type of surgical interventions

Timeframe: Up to 2 years

Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)

Timeframe: Up to 24 months

Trial details

NCT IDNCT05921994

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Hidradenitis Suppurativa trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients who provide written informed consent to participate in the study
✓. Male and female patients with ≥18 years of age
✓. Diagnosis of clinically unequivocal moderate to severe HS
✓. Patients for whom a therapy with secukinumab is medically indicated
✓. Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
✓. Treatment with secukinumab according to the latest version of SmPC
✓. Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit

Exclusion criteria

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

What they're measuring

Proportion of patients receiving up-titration

Timeframe: Up to 24 months

Proportion of patients receiving down-titration

Timeframe: Up to 24 months

Time to up-titration and down-titration

Timeframe: Up to 2 years

Duration of q4w treatment with secukinumab after dose reduction

Timeframe: Up to 2 years

Proportion of patients who receive more than one up-and/or down titration

Timeframe: Up to 24 months

Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab

Timeframe: Up to 2 years

Number and type of surgical interventions

Timeframe: Up to 2 years

Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)

Timeframe: Up to 24 months