Clinical trial • Phase III • Dermatology

SECUKINUMAB for Hidradenitis suppurativa

Phase III trial of SECUKINUMAB for Hidradenitis suppurativa.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Hidradenitis suppurativa
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Other

Key dates

Initial CTIS Submission Date
09-07-2024
First CTIS Authorization Date
06-08-2024

Trial design

Randomised, secukinumab 300 mg (subcutaneous) q4w or 300 mg q2w versus matching placebo (placebo to ain457 300mg/2ml solution for injection in pre-filled syringe).-controlled Phase III trial in Austria, Belgium, Croatia and others.

Randomised
Yes
Comparator
SECUKINUMAB 300 mg (subcutaneous) q4w or 300 mg q2w versus matching placebo (Placebo to AIN457 300mg/2mL solution for injection in pre-filled syringe).
Target Sample Size
349
Trial Duration For Participant
728

Eligibility

Recruits 349 Vulnerable population selected (isVulnerablePopulationSelected=true). Written informed consent must be obtained before any assessment is performed (see inclusion criterion 1). Adult main ICFs and specific follow-up ICFs for pregnant participants/partners are provided (multiple country-specific ICF documents listed). No paediatric assent process or minor consent/assent procedures are described in the available documentation..

Pregnancy Exclusion
8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. in European Union (EU) 20 weeks). Contraception methods include: Total abstinence, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For United Kingdom: with spermicidal foam/gel/film/cream/vaginal suppository. Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS).
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected=true). Written informed consent must be obtained before any assessment is performed (see inclusion criterion 1). Adult main ICFs and specific follow-up ICFs for pregnant participants/partners are provided (multiple country-specific ICF documents listed). No paediatric assent process or minor consent/assent procedures are described in the available documentation.

Inclusion criteria

  • {"criterion_text":"- 1. Written informed consent must be obtained before any assessment is performed\n- 2. Subjects who complete the whole study treatment period (52 weeks) in the core studies (CAIN457M2301 or CAIN457M2302) and have received secukinumab treatment during the Treatment Period 2 of the core studies."}

Exclusion criteria

  • {"criterion_text":"- 1. A protocol deviation in the core study which, according to the investigator will prevent the meaningful analysis of the extension study for the individual subject.\n- 2. Ongoing or planned use of prohibited HS or non-HS treatments. Time of use of prohibited treatments in the core study must continue to be adhered to.\n- 3. Subjects not expected to benefit from participation in the extension study, as assessed by the subject and investigator.\n- 4. Subjects whose participation in the extension study could expose them to an undue safety risk\n- 5. Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the study.\n- 6. Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal, such as inflammatory bowel disease), which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.\n- 7. Plans for administration of live vaccines during the study.\n- 8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. in European Union (EU) 20 weeks). Contraception methods include: Total abstinence, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For United Kingdom: with spermicidal foam/gel/film/cream/vaginal suppository. Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time to loss of response up to Week 104 (Randomized Withdrawal period) in subjects who were HiSCR responders at Week 52 in the core studies. HiSCR response is defined as at least 50% decrease in Abscess and inflammatory Nodule (AN) number relative to the Baseline visit in the core study, with no increase in the number of abscesses and in the number of draining fistulae. Loss of response is defined as: •\tat least a 50% or greater increase in AN count (abscess and/or nodules) at a regular or unsch","definition_or_measurement_approach":"Primary endpoint = time to loss of response up to Week 104 in HiSCR responders at Week 52. HiSCR response defined as ≥50% decrease in Abscess and inflammatory Nodule (AN) count from core-study Baseline with no increase in abscesses or draining fistulae. Loss of response defined as at least a 50% or greater increase in AN count (as specified in endpoint definition). Measurement is by lesion counts (AN) assessed at scheduled visits up to Week 104."}

Secondary endpoints

  • {"endpoint_text":"- Adverse events, laboratory values, vital signs","definition_or_measurement_approach":"Long-term safety and tolerability assessed by collection and evaluation of adverse events, abnormal laboratory values and vital signs."}

Recruitment

Planned Sample Size
349
Recruitment Window Months
73
Consent Approach
Written informed consent must be obtained before any assessment is performed (inclusion criterion 1). Multiple country-specific adult ICF documents are provided (Main ICF - Adult in multiple languages) and specific follow-up ICFs exist for pregnant participants and pregnant partners. Consent is therefore expected to be documented using adult ICFs; no assent process for minors is described in the available documents.

Geography

Total Number Of Sites
47
Total Number Of Participants
197

Austria

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
12-08-2024
Processing Time Days
14
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Medical University Of Vienna
Department Name
University Clinic of Dermatology
Contact Person Name
Constanze Jonak
Site Name
Ordensklinikum Linz GmbH
Department Name
Dep. Dermatology
Contact Person Name
Sepp Szepietowski
Contact Person Email
norbert.sepp@ordensklinikum.at

Belgium

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
07-08-2024
Processing Time Days
9
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
2513: Dermatology
Contact Person Name
Arjen Fokko Nikkels
Contact Person Email
af.nikkels@chuliege.be
Site Name
Hopital Erasme
Department Name
2511: Dermatology
Contact Person Name
Veronique Del Marmol
Contact Person Email
v.marmol@drvdm.be
Site Name
Universitair Ziekenhuis Gent
Department Name
2514: Dermatology
Contact Person Name
Jo Lambert
Contact Person Email
Jo.lambert@ugent.be

Croatia

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
13-08-2024
Processing Time Days
15
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
2533: Dermatology
Contact Person Name
Ines Sjerobabski Masnec

Greece

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
20-09-2024
Processing Time Days
53
Number Of Sites
4
Number Of Participants
26

Sites

Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
#2624:1st Department of Dermatology and Venereology
Contact Person Name
Dimitrios Ioannides
Contact Person Email
dem@auth.gr
Site Name
University General Hospital Attikon
Department Name
#2621:4th Department of Internal Medicine
Contact Person Name
Evangelos Giamarellos Bourboulis
Contact Person Email
egiamarel@med.uoa.gr
Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name
#2622:1st Department of Dermatology and Venereology
Contact Person Name
Dimitrios Rigopoulos
Contact Person Email
derm1@med.uoa.gr
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
#2623:2nd Dermatology University Clinic
Contact Person Name
Elisabeth Lazaridou
Contact Person Email
bethlaz@auth.gr

Hungary

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
06-08-2024
Processing Time Days
8
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
University Of Pecs
Department Name
2632: Bőr-, Nemikórtani és Onkodermatológiai Klinika
Contact Person Name
Zsuzsanna Lengyel
Contact Person Email
lengyel.zsuzsanna@pte.hu
Site Name
University Of Debrecen
Department Name
2634: Bőrgyógyászati Klinika
Contact Person Name
Éva Remenyik
Contact Person Email
remenyik@med.unideb.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
2635 : Bőrgyógyászati Osztály
Contact Person Name
Zita Battyáni
Contact Person Email
battyani_z@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
07-08-2024
Processing Time Days
9
Number Of Sites
8
Number Of Participants
31

Sites

Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
2748; Dermatología
Contact Person Name
Alejandro Molina Leyva
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
2750; Dermatología
Contact Person Name
Elena Castro Gonzalez
Site Name
Hospital Universitario De Fuenlabrada
Department Name
2745; Dermatología
Contact Person Name
Alberto Romero Maté
Contact Person Email
aromerom@salud.madrid.org
Site Name
Hospital De Manises
Department Name
2747; Medicina interna
Contact Person Name
Antonio Martorell Calatayud
Contact Person Email
antmarto@hotmail.com
Site Name
Hospital Universitario Puerta Del Mar
Department Name
2746; Dermatología
Contact Person Name
David Jimenez Gallo
Site Name
Hospital Universitario De La Princesa
Department Name
2749; Dermatología
Contact Person Name
Yolanda Delgado Jiménez
Contact Person Email
ydelgado@aedv.es
Site Name
Hospital General Universitario Dr. Balmis
Department Name
2743; Dermatología
Contact Person Name
Jose Carlos Pascual Ramirez
Contact Person Email
jcpascualramirez@hotmail.com
Site Name
Hospital Del Mar
Department Name
2752; Dermatología
Contact Person Name
Gemma Martin Ezquerra
Contact Person Email
GMartin@parcdesalutmar.cat

Netherlands

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
06-08-2024
Processing Time Days
8
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Bravis Ziekenhuis
Department Name
2681: Dermatology
Contact Person Name
Milan Tjioe
Contact Person Email
m.tjioe@bravis.nl

Poland

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
07-08-2024
Processing Time Days
9
Number Of Sites
6
Number Of Participants
27

Sites

Site Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Department Name
2691
Contact Person Name
Jacek Szepietowski
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
2695, Klinika Dermatologii
Contact Person Name
Adam Reich
Contact Person Email
adi_medicalis@go2.pl
Site Name
Prywatna Praktyka Lekarska Ewa Ring
Department Name
2693
Contact Person Name
Ewa Ring
Contact Person Email
ewajopowicz@wp.pl
Site Name
Labderm Essence Sp. z o.o.
Department Name
2692
Contact Person Name
Beata Bergler-Czop
Contact Person Email
bbergler-czop@sum.edu.pl
Site Name
Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
Department Name
2694
Contact Person Name
Joanna Narbutt
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
2696, Klinika Dermatologii
Contact Person Name
Witold Owczarek
Contact Person Email
Witold.owczarek@dermedicus.pl

Czechia

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
584
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
Nemocnice Jihlava prispevkova organizace
Department Name
2544: Kozni oddeleni
Contact Person Name
Marie Policarova
Contact Person Email
policarovam@nemji.cz
Site Name
Sanatorium Profesora Arenbergera
Department Name
2541: NA
Contact Person Name
Petr Arenberger
Contact Person Email
avemedica@email.cz
Site Name
Krajska zdravotni a.s.
Department Name
2543: Kozni oddeleni
Contact Person Name
Olga Filipovska
Contact Person Email
olga.filipovska@kzcr.eu
Site Name
Fakultni Nemocnice Plzen
Department Name
2542: Dermatovenerologicka klinika
Contact Person Name
Petra Cetkovska
Contact Person Email
cetkovska@fnplzen.cz

Italy

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
585
Number Of Sites
4
Number Of Participants
17

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
#2655: S.O.D. Clinica di Dermatologia
Contact Person Name
Elisa Molinelli
Site Name
Azienda USL Toscana Centro
Department Name
#2654: U.O. Dermatologia II
Contact Person Name
Francesca Prignano
Contact Person Email
francesca.prignano@unifi.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
#2658:U.O.C. Dermatologia
Contact Person Name
Angelo Valerio Marzano
Contact Person Email
angelo.marzano@unimi.it
Site Name
Universita' Degli Studi Di Ferrara
Department Name
#2657:U.O. di Dermatologia Dipartimento di Medicina Clinica e Specialistica
Contact Person Name
Alessandro Borghi
Contact Person Email
brglsn1@unife.it

Lithuania

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
617
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
2672: Dermatology
Contact Person Name
Skaidra Valiukeviciene
Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
2671: Dermatology
Contact Person Name
Tadas Raudonis
Contact Person Email
Tadas.raudonis@santa.lt

Portugal

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
585
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Hospital Cuf Descobertas S.A.
Department Name
2704; Serviço de Dermatologia
Contact Person Name
Pedro Bastos
Contact Person Email
pedro.mm.bastos@cuf.pt
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
2703, Serviço de Dermatologia
Contact Person Name
Inês Lobo
Contact Person Email
u08253@chporto.min-saude.pt
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
2701; Serviço de Dermatologia
Contact Person Name
Joana Cabete

Bulgaria

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
619
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
ASMC IPSMC Skin And Venereal Diseases
Department Name
2525:N/A
Contact Person Name
Ivan Botev
Contact Person Email
botev2@yahoo.com
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
2522:Dermatology and Venereology clinic
Contact Person Name
Evgenia Hristakieva
Contact Person Email
ehristakieva@gmail.com
Site Name
Ambulatoria Za Specializirana Medicinska Pomosht-Grupova Praktika Po Dermatologia Clinica Evroderma OOD
Department Name
2524:N/A
Contact Person Name
Nikolay Tsankov
Contact Person Email
tsankn@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
2523:Dermatology and Venereology Clinic
Contact Person Name
Dimitar Gospodinov
Contact Person Email
dkg@abv.bg

Slovakia

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
620
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
#2733:Klinika dermatovenerológie
Contact Person Name
Tomáš Kampe
Contact Person Email
tomaskampe@gmail.com
Site Name
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Department Name
#2731:Dermatovenerologické oddelenie
Contact Person Name
Tomas Uhrin
Contact Person Email
tomasuhrin404@gmail.com

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
PRA Hellas CRO A.E.
Responsibilities
CRO for Monitoring Services
Name
Icon Clinical Research Limited
Name
Syneos Health Inc.
Name
Parexel International (IRL) Limited
Responsibilities
Supply / rental of study equipment
Name
IQVIA Limited

Third parties

  • {"country":"Spain","full_name":"Rps Research Iberica S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive Activation sites activities","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"Drug storage, distribution, and destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Bulgaria","full_name":"S & D Pharma Logistics BG EOOD","duties_or_roles":"Storage and destruction of IMP","organisation_type":"Pharmaceutical company"}
  • {"country":"Croatia","full_name":"Medical Intertrade d.o.o.","duties_or_roles":"Destruction of the investigational medicinal products Services of import and distribution of IP to clinical sites","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local equipment storage","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"Electronic device for capturing PROS data","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Supply / rental of study equipment","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"PK and IG samples analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Bulgaria","full_name":"World Courier Bulgaria EOOD","duties_or_roles":"IMPD transportation from sites","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"CRO for Monitoring Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"long terms storage of DNA and biomarker samples","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Latvia","full_name":"Oribalt Riga SIA","duties_or_roles":"Drug destruction depot","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Somalogic Operating Co. Inc.","duties_or_roles":"Analysis of anonymized biomarker data","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
SECUKINUMAB
Active Substance
SECUKINUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
2
Starting Dose
300 mg
Dose Levels
300 mg q4w or 300 mg q2w
Frequency
q4w or q2w
Maximum Dose
300 mg
Investigational Product Name
Placebo to AIN457 300mg/2mL Solution for injection in pre-filled syringe
Modality
Other

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