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.

Germany435 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 range

18 Years – 99 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 99 Years

Sex

ALL

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

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