Clinical trial • Phase II • Immunology
IANALUMAB for Rheumatoid arthritis|Sjögren's syndrome|Systemic lupus erythematosus
Phase II trial of IANALUMAB for Rheumatoid arthritis|Sjögren's syndrome|Systemic lupus erythematosus.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Rheumatoid arthritis|Sjögren's syndrome|Systemic lupus erythematosus
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 22-05-2024
- First CTIS Authorization Date
- 17-09-2024
Trial design
Randomised, open-label, crossover comparison of ianalumab administered subcutaneously via different delivery formats: cohort 1 compares 1 x 2 ml auto-injector (ai) vs 2 x 1 ml pre-filled syringes (pfs); cohort 2 compares 1 x 2 ml pfs vs 2 x 1 ml pfs. dose specified in protocol as ianalumab 000 mg s.c. at steady state.-controlled, crossover Phase II trial in Netherlands, Germany, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Crossover comparison of ianalumab administered subcutaneously via different delivery formats: Cohort 1 compares 1 x 2 mL auto-injector (AI) vs 2 x 1 mL pre-filled syringes (PFS); Cohort 2 compares 1 x 2 mL PFS vs 2 x 1 mL PFS. Dose specified in protocol as ianalumab 000 mg s.c. at steady state.
- Crossover
- Yes
- Target Sample Size
- 98
Eligibility
Recruits 98 Vulnerable population selected. "Signed informed consent must be obtained before any assessment is performed." No separate assent process for minors is described (trial enrols adults aged 18-70)..
- Pregnancy Exclusion
- Pregnant or nursing (lactating) women.
- Vulnerable Population
- Vulnerable population selected. "Signed informed consent must be obtained before any assessment is performed." No separate assent process for minors is described (trial enrols adults aged 18-70).
Inclusion criteria
- {"criterion_text":"- Signed informed consent must be obtained before any assessment is performed."}
- {"criterion_text":"- Male and female patients aged 18 years to 70 years (inclusive)."}
- {"criterion_text":"- Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2 at screening."}
- {"criterion_text":"- Diagnosed with RA, SjD and/or SLE as determined by the investigator."}
- {"criterion_text":"- Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator."}
- {"criterion_text":"- Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment."}
- {"criterion_text":"- Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study."}
Exclusion criteria
- {"criterion_text":"- Use of prohibited therapies."}
- {"criterion_text":"- Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection."}
- {"criterion_text":"- Plans for administration of live vaccines during the study period."}
- {"criterion_text":"- Uncontrolled co-existing serious disease."}
- {"criterion_text":"- Pregnant or nursing (lactating) women."}
- {"criterion_text":"- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug."}
- {"criterion_text":"- US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment."}
Endpoints
Primary endpoints
- {"endpoint_text":"- For each cohort, Ianalumab serum concentrations (AUCtau and Cmax) over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24)","definition_or_measurement_approach":"Measurement of serum ianalumab concentrations to derive AUCtau and Cmax at steady state after the 3rd dose (week 8–12 window) and 6th dose (week 20–24 window)."}
Secondary endpoints
- {"endpoint_text":"- For each cohort, ianalumab PK parameters will be determined: Tmax and Ctrough","definition_or_measurement_approach":"Pharmacokinetic parameter determination (Tmax and Ctrough) from measured ianalumab serum concentrations."}
- {"endpoint_text":"- Adverse events, laboratory evaluations, vital signs, ECG parameters","definition_or_measurement_approach":"Safety monitoring through collection of adverse events, laboratory tests, vital signs and ECG assessments."}
- {"endpoint_text":"- Anti-ianalumab antibodies (ADA); incidence of ADA positive participants","definition_or_measurement_approach":"Immunogenicity testing for anti-ianalumab antibodies; reporting incidence of ADA-positive participants."}
Recruitment
- Planned Sample Size
- 98
- Recruitment Window Months
- 55
- Consent Approach
- Signed informed consent must be obtained from each participant prior to any assessments. Main informed consent forms and related participant-facing documents are available in multiple languages (examples in the submission: English, Dutch, German, Spanish, Italian, Hungarian, Polish, Czech). Additional information/ICFs exist for pregnant participants and pregnant partners and info sheets for female partners.
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 69
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 31-01-2025
- Processing Time Days
- 164
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Maasstad Ziekenhuis Stichting
- Department Name
- 2301:Rheumatology
- Contact Person Name
- Radjesh Bisoendial
- Contact Person Email
- BisoendialR@maasstadziekenhuis.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 29-01-2025
- Processing Time Days
- 168
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Studienambulanz Rheumazentrum Ratingen GbR
- Department Name
- 2052:N/A
- Contact Person Name
- Siegfried Wassenberg
- Contact Person Email
- wassenberg@rhzr.de
- Site Name
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
- Department Name
- 2051:Rheumazentrum Ruhrgebiet
- Contact Person Name
- Ioana Andreica
- Contact Person Email
- Ioana.andreica@elisabethgruppe.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- 2053:Klinik fuer Rheumatologie und Klinische Immunologie
- Contact Person Name
- Stephanie Finzel
- Contact Person Email
- Stephanie.finzel@uniklinik-freiburg.de
Italy
- Earliest CTIS Part Ii Submission Date
- 31-07-2024
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 594
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
- Department Name
- 2152: U.O. Diagnosi e Terapia delle Malattie Allergiche e del Sistema Immunitario
- Contact Person Name
- Massimo Triggiani
- Contact Person Email
- mtriggiani@unisa.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 643
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- Revita Kft.
- Department Name
- 2107
- Contact Person Name
- Regina Cseuz
- Contact Person Email
- recseuz@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- 2104
- Contact Person Name
- Gabriella Szucs
- Contact Person Email
- szucs.gabriella@med.unideb.hu
- Site Name
- Qualiclinic Kft.
- Department Name
- 2108
- Contact Person Name
- Istvan Szombati
- Contact Person Email
- i.szombati@qclinic.hu
- Site Name
- University Of Debrecen
- Department Name
- 2101: Immunologiai Tanszek
- Contact Person Name
- Antonia Szanto
- Contact Person Email
- szanto.antonia@med.unideb.hu
Poland
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 572
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Malopolskie Badania Kliniczne Sp. z o.o.
- Department Name
- 2204:Reumatologia
- Contact Person Name
- Bogdan Batko
- Contact Person Email
- bpbatko@gmail.com
- Site Name
- Reumed Sp. z o.o.
- Department Name
- 2203:Reumatologia
- Contact Person Name
- Marcin Mazurek
- Contact Person Email
- mamazurek@tlen.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 19-08-2024
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 575
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Revmatologie s.r.o.
- Department Name
- 2003:Rheumatology
- Contact Person Name
- Leona Prochazkova
- Contact Person Email
- revmatologie.prochazkova@seznam.cz
- Site Name
- Revmatologicky Ustav
- Department Name
- 2002:Rheumatology
- Contact Person Name
- Sarka Forejtova
- Contact Person Email
- forejtova@revma.cz
- Site Name
- Medical Plus s.r.o.
- Department Name
- 2001:Rheumatology
- Contact Person Name
- Eva Dokoupilova
- Contact Person Email
- evadokoupil@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 19-08-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 582
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- 2254:Reumatologia
- Contact Person Name
- Francisco Javier Blanco García
- Contact Person Email
- fblagar@sergas.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- 2251:Reumatologia
- Contact Person Name
- Eva María Perez Pampin
- Contact Person Email
- eva.perez.pampin@sergas.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- 2255:Reumatologia
- Contact Person Name
- Carlos Antonio Guillén Astete
- Contact Person Email
- carlosantonio.guillen@salud.madrid.org
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
- code:1
- Name
- Parexel International (IRL) Limited
- Responsibilities
- code:12
- Name
- Syneos Health Inc.
- Responsibilities
- code:1
- Name
- Iqvia Biotech LLC
- Responsibilities
- codes:14,3
- Name
- Labcorp Early Development Laboratories Limited
- Responsibilities
- code:4
Third parties
- {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site (code:15)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"codes:14,3","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Kayentis US","duties_or_roles":"PRO licensing (code:15); code:7","organisation_type":"Health care"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Patient Reported Outcomes –(PRO) formatting, translations, an licensing and ICF translations (code:15)","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Kayentis","duties_or_roles":"PRO licensing (code:15); code:7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive (code:15)","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"Drug storage, distribution, and destruction (code:15)","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products (code:15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- VAY736
- Active Substance
- IANALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus:1
- Frequency
- Monthly
- Maximum Dose
- 300 mg (maxDailyDoseAmount: 300)
- Investigational Product Name
- TENOFOVIR ALAFENAMIDE
- Active Substance
- TENOFOVIR ALAFENAMIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- prodAuthStatus:2
- Starting Dose
- 25 mg (maxDailyDoseAmount: 25)
- Maximum Dose
- 25 mg (maxDailyDoseAmount: 25)
- Investigational Product Name
- TENOFOVIR DISOPROXIL / EMTRICITABINE
- Active Substance
- Tenofovir disoproxil; Emtricitabine
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- prodAuthStatus:2
- Starting Dose
- 50 mg (maxDailyDoseAmount: 50)
- Maximum Dose
- 50 mg (maxDailyDoseAmount: 50)
- Investigational Product Name
- ENTECAVIR
- Active Substance
- ENTECAVIR
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- prodAuthStatus:2
- Starting Dose
- 0.5 mg (maxDailyDoseAmount: 0.5)
- Maximum Dose
- 0.5 mg (maxDailyDoseAmount: 0.5)
- Investigational Product Name
- Glucocorticoids (class)
- Active Substance
- Glucocorticoids (unspecified)
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- prodAuthStatus:2
- Starting Dose
- 50 mg (maxDailyDoseAmount: 50)
- Maximum Dose
- 50 mg (maxDailyDoseAmount: 50)
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