Long-term treatment of hidradenitis suppurativa with secukinumab
Zusammenfassung der Studie
This study is an extension study of the main studies CAIN457M2301 and CAIN457M2302. Both studies were also conducted at Swiss centers. Eligible patients are those who completed the entire study treatment phase (52 weeks) in one of the main studies. This study examines the safety, tolerability, and efficacy of further administration of secukinumab for up to 4 years in individuals affected by hidradenitis suppurativa (HS). Secukinumab is a medication that is a monoclonal antibody. Secukinumab binds to and reduces the activity of a cytokine (a messenger in the body) called interleukin-17A (IL-17A). IL-17A is believed to be partially responsible for the inflammation in HS (pain, swelling, and redness) and that IL-17A contributes to HS symptoms. A medication that acts on IL-17A could therefore help alleviate these symptoms. Secukinumab is a medication that is not approved by the Swiss Agency for Therapeutic Products Swissmedic for the treatment of patients with HS, but it has been approved for the treatment of individuals with other conditions (psoriasis, psoriatic arthritis, ankylosing spondylitis) and is marketed under the name Cosentyx. Patients are randomly assigned to one of two treatment groups 1) The same dose of secukinumab as in the previous study (66% probability) or 2) Placebo (33% probability). If placebo is assigned and symptoms worsen, the placebo is discontinued and there is the possibility to start an open-label treatment with secukinumab. After a maximum period of 1 year, each participant has the opportunity to continue with an open-label secukinumab treatment for up to an additional 3 years, administered every 2 or 4 weeks.
(BASEC)
Untersuchte Intervention
When a patient has completed the entire study treatment phase (52 weeks) of one of the main studies and agrees to participate in this study, the participant is randomly assigned to one of the 2 following treatment groups: - Secukinumab 300 mg every 2 weeks or every 4 weeks (the same dose as in the previous study is continued) - Placebo group for secukinumab treatment with 300 mg every 2 weeks or every 4 weeks. The study medication is provided in 2 ml pre-filled syringes and is injected under the skin. Participants are expected to self-administer the study treatment (inject), if possible. Participation in the study may last a total of 4 years.
(BASEC)
Untersuchte Krankheit(en)
This study examines patients with hidradenitis suppurativa (HS). HS is a chronic inflammatory skin disease in which lumps form under the skin in areas where skin rubs against skin, which can lead to inflammatory pain, fluid drainage, scarring, and potentially even reduced mobility of the arms and legs.
(BASEC)
Individuals who have completed the entire study treatment phase (52 weeks) of one of the main studies (CAIN457M2301 or CAIN457M2302) may participate. (BASEC)
Ausschlusskriterien
Individuals who do not practice adequate contraception, as well as pregnant and breastfeeding women, may not participate. Additionally, individuals who would take certain medications in parallel with the study that are not allowed are also excluded. Further information can be obtained from the study physician. (BASEC)
Studienstandort
Bern, Genf, Lausanne
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Kerstin Wanke
+41793308956
kerstin.wanke@clutternovartis.comNovartis Pharma Schweiz AG
(BASEC)
Allgemeine Auskünfte
Novartis Pharmaceuticals
(ICTRP)
Wissenschaftliche Auskünfte
Novartis Pharmaceuticals
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
08.06.2020
(BASEC)
ICTRP Studien-ID
NCT04179175 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A multicenter, double-blind, randomized withdrawal extension study of subcutaneous secukinumab to demonstrate long-term efficacy, safety and tolerability in subjects with moderate to severe hidradenitis suppurativa (BASEC)
Wissenschaftlicher Titel
A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa (ICTRP)
Öffentlicher Titel
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa (ICTRP)
Untersuchte Krankheit(en)
Hidradenitis Suppurativa (ICTRP)
Untersuchte Intervention
Drug: secukinumabDrug: secukinumab (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- written informed consent must be obtained before any assessment is performed
- subject must have completed the study treatment period (52 weeks) in the core
studies (AIN457M2301 or AIN457M2302) and had received secukinumab treatment during
Treatment Period 2
Exclusion Criteria:
- protocol deviation in the core study which will prevent the meaningful analysis of
the extension study
- ongoing or planned use of prohibited HS or non-HS treatment
- participation in the extension could expose the subject to an undue safety risk
- current sever progressive or uncontrolled disease which renders the subject
unsuitable for the study (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders;Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders (ICTRP)
Number of Participants With Treatment Emergent Adverse Events (ICTRP)
Registrierungsdatum
25.11.2019 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Novartis Pharmaceuticals, Novartis Pharmaceuticals (ICTRP)
Sekundäre IDs
2023-508956-20, CAIN457M2301E1 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT04179175 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar