Clinical trial NCT05921994: 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.
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis suppurativa
HS
secukinumab
Germany
NIS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients, being treated for HS with secukinumab according to the summary of product characteristics (SmPC), after the approval of secukinumab has been granted in this indication.

Brief 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.

Detailed description: The study will collect data from patients during routine secukinumab treatment and will be representative of the real-world patient population eligible for secukinumab treatment in Germany.

In order to attain widespread representation of health care practices related to the use of secukinumab in the approved indication of moderate to severe HS, a broad spectrum of dermatology practices and clinics who are treating patients with HS across Germany will be included.

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

Primary outcomes:
measure: Proportion of patients receiving up-titration
timeFrame: Up to 24 months
measure: Proportion of patients receiving down-titration
timeFrame: Up to 24 months
measure: Time to up-titration and down-titration
timeFrame: Up to 2 years
measure: Duration of q4w treatment with secukinumab after dose reduction
timeFrame: Up to 2 years
measure: Proportion of patients who receive more than one up-and/or down titration
timeFrame: Up to 24 months
measure: Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab
timeFrame: Up to 2 years
measure: Number and type of surgical interventions
timeFrame: Up to 2 years
measure: Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)
timeFrame: Up to 24 months
measure: mean change of International Hidradenitis Suppurativa Severity Score System (IHS4)
timeFrame: Up to 24 months
measure: Proportion of patients achieving a 5-point reduction of their Dermatology Life Quality Index (DLQI) questionnaire
timeFrame: Up to 24 months
measure: Mean reduction of Abscesses and inflammatory nodules (AN) count
timeFrame: Up to 24 months
measure: Proportion of patients achieving a 30% reduction of pain Numerical Rating scale 30 (NRS30)
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Ahaus
country: Germany
facility: Novartis Investigative Site
city: Annaberg-Buchholz
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Steben
country: Germany
facility: Novartis Investigative Site
city: Baden-Baden
country: Germany
facility: Novartis Investigative Site
city: Bergen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Brandenburg An Der Havel
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Bueckeburg
country: Germany
facility: Novartis Investigative Site
city: Buxtehude
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Delitzsch
country: Germany
facility: Novartis Investigative Site
city: Dessau Rosslau
country: Germany
facility: Novartis Investigative Site
city: Dorsten
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duren
country: Germany
facility: Novartis Investigative Site
city: Emsdetten
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Falkenberg
country: Germany
facility: Novartis Investigative Site
city: Falkensee
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Freising
country: Germany
facility: Novartis Investigative Site
city: Geilenkirchen
country: Germany
facility: Novartis Investigative Site
city: Gelsenkirchen
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Gernsbach
country: Germany
facility: Novartis Investigative Site
city: Gladbeck
country: Germany
facility: Novartis Investigative Site
city: Grossenhain
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hasfurt
country: Germany
facility: Novartis Investigative Site
city: Haslach im Kinzigtal
country: Germany
facility: Novartis Investigative Site
city: Hofgeismar
country: Germany
facility: Novartis Investigative Site
city: Ilmenau
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Juelich
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Kempen
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Krefeld
country: Germany
facility: Novartis Investigative Site
city: Kroepelin
country: Germany
facility: Novartis Investigative Site
city: Kronach
country: Germany
facility: Novartis Investigative Site
city: Kulmbach
country: Germany
facility: Novartis Investigative Site
city: Lauf
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lingen
country: Germany
facility: Novartis Investigative Site
city: Luebeck
country: Germany
facility: Novartis Investigative Site
city: Lutherstadt Wittenberg
country: Germany
facility: Novartis Investigative Site
city: Lutherstadt Wittenberg
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Moenchengladbach
country: Germany
facility: Novartis Investigative Site
city: Monchengladbach
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Neu Wulmstorf
country: Germany
facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Neuwied
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Oberasbach
country: Germany
facility: Novartis Investigative Site
city: Oelde
country: Germany
facility: Novartis Investigative Site
city: Oelsnitz
country: Germany
facility: Novartis Investigative Site
city: Panketal
country: Germany
facility: Novartis Investigative Site
city: Peitz
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Remscheid
country: Germany
facility: Novartis Investigative Site
city: Rheinstetten Moersch
country: Germany
facility: Novartis Investigative Site
city: Schweinfurt
country: Germany
facility: Novartis Investigative Site
city: Selters
country: Germany
facility: Novartis Investigative Site
city: Simmern
country: Germany
facility: Novartis Investigative Site
city: Soest
country: Germany
facility: Novartis Investigative Site
city: Stolberg
country: Germany
facility: Novartis Investigative Site
city: Unna
country: Germany
facility: Novartis Investigative Site
city: Vechta
country: Germany
facility: Novartis Investigative Site
city: Wittlich
country: Germany
facility: Novartis Investigative Site
city: Wuppertal
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: