Clinical trial • Phase III • Immunology

IANALUMAB for Systemic lupus erythematosus

Phase III trial of IANALUMAB for Systemic lupus erythematosus.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic lupus erythematosus
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
27-05-2024
First CTIS Authorization Date
18-06-2024

Trial design

Randomised, placebo to vay736 (matching placebo). dose and schedule for the comparator are not specified in the provided documents.-controlled Phase III trial across 33 sites in Germany, Romania, France and others.

Randomised
Yes
Comparator
Placebo to VAY736 (matching placebo). Dose and schedule for the comparator are not specified in the provided documents.
Target Sample Size
213
Trial Duration For Participant
420

Eligibility

Recruits 213 paediatric patients.

Pregnancy Exclusion
Pregnant or nursing (lactating) women.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent documents are provided (L1_ICF - Main ICF - Adult and multiple related information sheets and follow-up/pregnancy partner documents in German, Romanian, French, Italian and English are listed). The available records do not state explicit paediatric assent or paediatric-specific consent procedures; inclusion criteria permit participants aged 12+ in some countries but note restriction to 18+ in EEA countries where minors are not allowed.

Inclusion criteria

  • {"criterion_text":"- Male and Female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed.\n- Diagnosis of systemic lupus erythematosus (SLE) meeting the EULAR/ACR SLE classification criteria at least 6 months prior to screening\n- Elevated serum titers at screening of Antinuclear Antibodies (≥1:80) as determined by a central laboratory with a SLE typical fluorescence pattern.\n- Currently receiving corticosteroids and/or anti-malarial treatment and/or another Disease-modifying antirheumatic drug (DMARD) as specified in the protocol.\n- SLEDAI-2K Criteria at screening: SLEDAI-2K score ≥6 points, excluding points attributed to \"fever\", \"lupus headache\", \"alopecia\", and \"organic brain syndrome\" British Isles Lupus Assessment Group-2004 disease activity level at screening of at least 1 of the following: British Isles Lupus Assessment Group-2004 level A disease in ≥1 organ system, Or British Isles Lupus Assessment Group-2004 level B disease in ≥2 organ systems\n- Weigh at least 35 kg at screening"}

Exclusion criteria

  • {"criterion_text":"- Prior treatment with Ianalumab\n- Receipt of live/attenuated vaccine within a 4-week period before first dosing\n- Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms\n- Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CS\n- History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer\n- Pregnant or nursing (lactating) women.\n- History of receiving following treatment I) high dose corticosteroids, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) 12 weeks prior to screening II) Cyclophosphamide or biologics such as immunoglobulins (i.v. or XXX), plasmapheresis, anti-type I interferon receptor biologic agents, anti- CD40 agents, CTLA4-Fc Ig or B-cell activating factor-targeting agents administered within 24 weeks prior to screening; belimumab administered within 12 weeks prior to screening. III) Any B-cell depleting therapies, other than ianalumab administered within 36 weeks prior to randomization or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower) IV) Traditional Chinese medicines administered within 30 days prior to randomization\n- Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection\n- Chronic infection with hepatitis B (HBV) or hepatitis C (HCV)\n- Evidence of active tuberculosis infection\n- History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening\n- Any one of the following laboratory values prior to randomization: Platelets <25000/mm^3 (<25 x 10^3/μL) Hemoglobin (Hgb) <8.0 g/dL (<5 mmol/L), or <7.0 g/dL (<4.3 mmol/L) if related to participant's SLE such as in active hemolytic anemia Absolute neutrophil count (ANC) (<0.8 x 10^3/ μL)\n- Severe organ dysfunction or life-threatening disease at screening\n- Presence of severe lupus kidney disease as defined by proteinuria above 2g/day or equivalent using spot urine protein creatinine ratio\n- XXX\n- Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants achieving SRI-4 at Week 60","definition_or_measurement_approach":"Proportion of participants achieving Systemic Lupus Erythematosus Responder Index (SRI-4) assessed at Week 60 (binary responder outcome measured at Week 60 as specified in endpoint)."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants with no moderate or severe British Isles Lupus Assessment Group flare up to Week 60\n- Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower\n- Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Week 60\n- Proportion of participants achieving Lupus Low Disease Activity State at Week 60\n- Time to first occurrence of SRI-4 from baseline to Week 60\n- Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower\n- Proportion of participants achieving SRI-6 at Week 60\n- Proportion of participants achieving SF-36 Bodily Pain response at Week 60\n- Proportion of participants with AEs and SAEs\n- Clinical laboratory measurements\n- Vital Signs\n- Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time\n- Ianalumab concentration in serum during the treatment and followup (up to the end of study)","definition_or_measurement_approach":"Most secondary endpoints are proportions or rates assessed at specified timepoints (commonly Week 60) or over the study period (e.g., no moderate/severe BILAG flare up up to Week 60). Time-to-event endpoint (Time to first occurrence of SRI-4) measured from baseline up to Week 60. Safety endpoints include incidence of AEs/SAEs, clinical lab measurements and vital signs. Immunogenicity measured by ADA assay titers over time; PK measured by serum concentration sampling during treatment and follow-up (up to end of study)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
213
Recruitment Window Months
68
Consent Approach
Informed consent obtained using Main ICF - Adult and related subject information documents; ICF documents are available in multiple languages (German, Romanian, French, Italian and English as per document listings). There are also specific follow-up information sheets for pregnant participants/partners and additional info sheets. The available documentation does not include explicit paediatric assent forms; inclusion of participants aged 12+ is permitted in some countries but restricted to 18+ in EEA countries per inclusion criteria.

Methods

  • Country-specific recruitment materials (K1_Recruitment Arrangements) including Country-Flyer, Country-Poster and Country-Website documents (examples present for Germany, Romania, France, Italy).
  • Advertisements (K2_Advertisements) for France and Italy as listed in the submitted documents.
  • Recruitment posters/flyers and patient-facing materials (e.g., patient-facing materials and country posters/flyers) provided for site-level recruitment.

Geography

Total Number Of Sites
33
Total Number Of Participants
67

Germany

Earliest CTIS Part Ii Submission Date
04-04-2024
Latest Decision Or Authorization Date
18-06-2024
Processing Time Days
75
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Medicover GmbH
Department Name
#3562 : Medicover München Ost MVZ
Principal Investigator Name
David Kofler
Principal Investigator Email
David.Kofler@medicover.de
Contact Person Name
David Kofler
Contact Person Email
David.Kofler@medicover.de
Site Name
University Hospital Cologne AöR
Department Name
#3557: Innere Medizin
Principal Investigator Name
Philipp Koehler
Principal Investigator Email
philipp.koehler@uk-koeln.de
Contact Person Name
Philipp Koehler
Contact Person Email
philipp.koehler@uk-koeln.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
#3558: Nephrologie, Rheumatologie und klinische Immunologie
Principal Investigator Name
Julia Weinmann-Menke
Principal Investigator Email
julia.weinmann-menke@unimedizin-mainz.de
Contact Person Name
Julia Weinmann-Menke
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
#3553: Rheumatologie und klinische Immunologie
Principal Investigator Name
Thomas Doerner
Principal Investigator Email
thomas.doerner@charite.de
Contact Person Name
Thomas Doerner
Contact Person Email
thomas.doerner@charite.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
#3556: Endokrinologie, Nephrologie, Rheumatologie
Principal Investigator Name
Ulf Wagner
Principal Investigator Email
ulf.wagner@medizin.uni-leipzig.de
Contact Person Name
Ulf Wagner
Site Name
Medical Center - University Of Freiburg
Department Name
#3555: Rheumatologie und klinische Immunologie Dept. Innere Medizin
Principal Investigator Name
Stephanie Finzel
Principal Investigator Email
finzel@uniklinik-freiburg.de
Contact Person Name
Stephanie Finzel
Contact Person Email
finzel@uniklinik-freiburg.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
#3560: Medizinische Klinik II
Principal Investigator Name
Thomas Rauen
Principal Investigator Email
trauen@ukaachen.de
Contact Person Name
Thomas Rauen
Contact Person Email
trauen@ukaachen.de
Site Name
Rheumatologische Schwerpunktpraxis Erlangen
Department Name
#3561: Rheumatologische Schwerpunktpraxis Erlangen
Principal Investigator Name
Stefan Kleinert
Principal Investigator Email
Stefan.kleinert@pgrn.de
Contact Person Name
Stefan Kleinert
Contact Person Email
Stefan.kleinert@pgrn.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
#3552: Rheumazentrum
Principal Investigator Name
Ioana Andreica
Principal Investigator Email
Ioana.andreica@elisabethgruppe.de
Contact Person Name
Ioana Andreica

Romania

Earliest CTIS Part Ii Submission Date
04-04-2024
Latest Decision Or Authorization Date
21-06-2024
Processing Time Days
78
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
3302; Rheumatology
Principal Investigator Name
Rednic Simona
Principal Investigator Email
srednic@umfcluj.ro
Contact Person Name
Rednic Simona
Contact Person Email
srednic@umfcluj.ro
Site Name
Centrul Medical Perseide S.R.L.
Department Name
3306; Rheumatology
Principal Investigator Name
Anca Maria Dima
Principal Investigator Email
anca.dima@perseide.ro
Contact Person Name
Anca Maria Dima
Contact Person Email
anca.dima@perseide.ro
Site Name
Saint Maria Hospital
Department Name
3304; Rheumatology
Principal Investigator Name
Balanescu Andra
Principal Investigator Email
balanescu.andra@gmail.com
Contact Person Name
Balanescu Andra
Contact Person Email
balanescu.andra@gmail.com
Site Name
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Department Name
3301; Rheumatology
Principal Investigator Name
Duca Liliana
Principal Investigator Email
liliduca@neomed.org
Contact Person Name
Duca Liliana
Contact Person Email
liliduca@neomed.org

France

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
28-06-2024
Processing Time Days
3
Number Of Sites
11
Number Of Participants
14

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
#3509 - Service de Médecine interne
Principal Investigator Name
Karim Sacre
Principal Investigator Email
karim.sacre@aphp.fr
Contact Person Name
Karim Sacre
Contact Person Email
karim.sacre@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
#3505 - Service de Médecine interne
Principal Investigator Name
Jacques Morel
Principal Investigator Email
j-morel@chu-montpellier.fr
Contact Person Name
Jacques Morel
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
#3510 - Service de Médecine interne
Principal Investigator Name
Laurent Sailler
Principal Investigator Email
sailler.l@chu-toulouse.fr
Contact Person Name
Laurent Sailler
Contact Person Email
sailler.l@chu-toulouse.fr
Site Name
Hospital Edouard Herriot
Department Name
3514: Service de médecine interne
Principal Investigator Name
Thomas Barba
Principal Investigator Email
Thomas.barba@chu-lyon.fr
Contact Person Name
Thomas Barba
Contact Person Email
Thomas.barba@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
#3504 - Service de Médecine Interne
Principal Investigator Name
Christian Lavigne
Principal Investigator Email
chlavigne@chu-angers.fr
Contact Person Name
Christian Lavigne
Contact Person Email
chlavigne@chu-angers.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
#3508 - Service de Médecine Interne et Immunologie Clinique
Principal Investigator Name
Nicole Ferreira-Maldent
Principal Investigator Email
n.ferreira-maldent@chu-tours.fr
Contact Person Name
Nicole Ferreira-Maldent
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
#3501 - Service de médecine interne
Principal Investigator Name
Zahir Amoura
Principal Investigator Email
zahir.amoura@aphp.fr
Contact Person Name
Zahir Amoura
Contact Person Email
zahir.amoura@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse (second entry)
Department Name
#3512 - Service de Médecine interne – Immunologie Clinique
Principal Investigator Name
Gregory Pugnet
Principal Investigator Email
pugnet.g@chu-toulouse.fr
Contact Person Name
Gregory Pugnet
Contact Person Email
pugnet.g@chu-toulouse.fr
Site Name
Hopital Cochin Saint Vincent De Paul
Department Name
#3502 - Service de Médecine interne
Principal Investigator Name
Veronique Le Guern
Principal Investigator Email
veronique.le-guern@aphp.fr
Contact Person Name
Veronique Le Guern
Contact Person Email
veronique.le-guern@aphp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
#3507 - Service de Médecine Interne
Principal Investigator Name
Laurence Bouillet
Principal Investigator Email
lbouillet@chu-grenoble.fr
Contact Person Name
Laurence Bouillet
Contact Person Email
lbouillet@chu-grenoble.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
3513: Service de médecine interne
Principal Investigator Name
Ludovic Trefond
Principal Investigator Email
ltrefond@chu-clermontferrand.fr
Contact Person Name
Ludovic Trefond

Italy

Earliest CTIS Part Ii Submission Date
04-04-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
81
Number Of Sites
9
Number Of Participants
18

Sites

Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
3607; S.C.D.U. Allergologia e Immunologia Clinica Presidio Ospedaliero Unberto I
Principal Investigator Name
Luisa Brussino
Principal Investigator Email
Luisa.brussino@unito.it
Contact Person Name
Luisa Brussino
Contact Person Email
Luisa.brussino@unito.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
3608; S.O.D. Clinica Medica
Principal Investigator Name
Gianluca Moroncini
Principal Investigator Email
g.moroncini@univpm.it
Contact Person Name
Gianluca Moroncini
Contact Person Email
g.moroncini@univpm.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
3602; U.O Reumatologia Stabilimento Ospedale S. Chiara
Principal Investigator Name
Marta Mosca
Principal Investigator Email
marta.mosca@med.unipi.it
Contact Person Name
Marta Mosca
Contact Person Email
marta.mosca@med.unipi.it
Site Name
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Department Name
3606; U.O.C. Reumatologia Clinica Presidio Ospedaliero G. Pini
Principal Investigator Name
Maria Gerosa
Principal Investigator Email
maria.gerosa@unimi.it
Contact Person Name
Maria Gerosa
Contact Person Email
maria.gerosa@unimi.it
Site Name
Universita' Degli Studi Di Ferrara
Department Name
3604; U.O.C. Reumatologia
Principal Investigator Name
Marcello Govoni
Principal Investigator Email
gvl@unife.it
Contact Person Name
Marcello Govoni
Contact Person Email
gvl@unife.it
Site Name
Azienda Sanitaria Locale Napoli 1 Centro
Department Name
3612: UOSD Reumatologia
Principal Investigator Name
Enrico Tirri
Principal Investigator Email
enrico.tirri@aslnapoli1centro.it
Contact Person Name
Enrico Tirri
Site Name
San Camillo Forlanini Hospital
Department Name
3609; U.O.C. Reumatologia
Principal Investigator Name
Gian Domenico Sebastiani
Principal Investigator Email
gsebastiani@scamilloforlanini.rm.it
Contact Person Name
Gian Domenico Sebastiani
Site Name
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta
Department Name
3610; UOS Reumatologia UOC Medicina Interna
Principal Investigator Name
Giovanni Italiano
Principal Investigator Email
reumagio@gmail.com
Contact Person Name
Giovanni Italiano
Contact Person Email
reumagio@gmail.com
Site Name
Azienda Ospedaliera di Padova
Department Name
3603; U.O.C. di Reumatologia DIDAS Medicina e Sistemi
Principal Investigator Name
Luca Iaccarino
Principal Investigator Email
luca.iaccarino@unipd.it
Contact Person Name
Luca Iaccarino
Contact Person Email
luca.iaccarino@unipd.it

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [1]
Name
Parexel International (IRL) Limited
Responsibilities
sponsorDuties code: 12
Name
Iqvia Holdings Inc.
Responsibilities
Management of drug supply logistics, dispensing and unblinding. Develop IRT system; sponsorDuties code: 3
Name
Iqvia Laboratories Limited
Responsibilities
sponsorDuties codes: [4]
Name
Labcorp Central Laboratory Services LP
Responsibilities
sponsorDuties codes: [4]

Third parties

  • {"country":"Denmark","full_name":"Eurofins Biopharma Product Testing Denmark A/S","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Licensing and Translations of Patient Reported Outcomes and Clinician Reported outcomes","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patient Facing Materials","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"Management of drug supply logistics, dispensing and unblinding. Develop IRT system; sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties code: 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"sponsorDuties codes: [4]","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":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local equipment storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Mipharm S.p.A.","duties_or_roles":"Local drug supply Local equipment storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
VAY736
Active Substance
IANALUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
ENTECAVIR
Active Substance
ENTECAVIR
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
0.5 mg
Investigational Product Name
Placebo to VAY736
Modality
Other
Authorisation Status
prodAuthStatus: N/A
Investigational Product Name
TENOFOVIR DISOPROXIL
Active Substance
EMTRICITABINE, TENOFOVIR DISOPROXIL
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
300 mg
Investigational Product Name
TENOFOVIR ALAFENAMIDE
Active Substance
TENOFOVIR ALAFENAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
25 mg
Investigational Product Name
-
Active Substance
-
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
50 mg
Combination Treatment
Yes

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