Clinical trial • Phase III • Musculoskeletal|Dermatology|Immunology
USTEKINUMAB for Juvenile psoriatic arthritis
Phase III trial of USTEKINUMAB for Juvenile psoriatic arthritis.
Overview
- Trial Therapeutic Area
- Musculoskeletal|Dermatology|Immunology
- Trial Disease
- Juvenile psoriatic arthritis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 08-05-2024
- First CTIS Authorization Date
- 17-07-2024
Trial design
open-label, cohort 1: ustekinumab (subcutaneous; products: stelara 45 mg and stelara 90 mg solution for injection in pre-filled syringe; dosing interval referenced as 12-week interval for pk assessments). cohort 2: guselkumab (subcutaneous; products: guselkumab 100 mg/ml or guselkumab formulations; dosing intervals referenced as 4- or 8-week intervals for pk assessments).-controlled Phase III trial across 24 sites in Denmark, Italy, Netherlands and others.
- Open Label
- Yes
- Comparator
- Cohort 1: Ustekinumab (subcutaneous; products: STELARA 45 mg and STELARA 90 mg solution for injection in pre-filled syringe; dosing interval referenced as 12-week interval for PK assessments). Cohort 2: Guselkumab (subcutaneous; products: Guselkumab 100 mg/mL or guselkumab formulations; dosing intervals referenced as 4- or 8-week intervals for PK assessments).
- Target Sample Size
- 28
- Trial Duration For Participant
- 476
Eligibility
Recruits 28 paediatric patients.
- Vulnerable Population
- The trial enrols pediatric participants aged ≥5 to <18 years (vulnerable population selected). Consent and assent handling includes age-specific informed consent and assent documents: parental/legal guardian consent required; assent from children/adolescents (documents and assent forms available for ages including 6-12 and 13-17). There are specific ICF/assent and related materials (child, adolescent, parental/legal guardian, withdrawal, pregnant partner, turning 18) provided in multiple country-language versions (examples in French, Spanish, German, Polish indicated in the submitted documents).
Inclusion criteria
- {"criterion_text":"- ≥5 to <18 years of age, inclusive.\n- Diagnosis of jPsA by Vancouver inclusion criteria, with exclusion of ERA. Diagnosis made ≥3 months (ie. 90 days) prior to screening. Arthritis plus psoriasis, or arthritis plus ≥2 of the following: dactylitis, nail pits, family history of psoriasis in a first- or second-degree relative, psoriasis-like rash.\n- Active disease in ≥3 joints at screening and at Week 0 (defined as swelling or loss of motion with pain and/or tenderness). Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint\n- Have active disease despite previous non-biologic DMARD and/or NSAID therapy: •\tNon-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance. •\tNSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance.\n- If previously treated with an anti-TNFα agent (such as adalimumab, etanercept, infliximab, golimumab [SC or IV], certolizumab pegol, or their respective biosimilars) or other biologic agents that are not included in the exclusion criteria, these agents should have been discontinued taking into consideration their elimination half-life, dosing frequency and acceptable clinical practice, before first study intervention administration (see Appendix 7 [Section 10.7] for Table 7 with the required minimal washout period for a specific prior treatment). Refer to Appendix 18 (Section 10.18.1) for country-specific requirements in France for the required minimum washout periods for Anti-TNFα agents."}
Exclusion criteria
- {"criterion_text":"- Participants with enthesitis-related arthritis (ERA; see definition in Appendix 17 of the study protocol)\n- Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy within the timeframe specified before the planned first dose of study intervention.\n- If participants were non-responders to previously received IL-23 blockers including guselkumab, tildrakizumab (MK3222) and risankizumab (BI-655066). Prior non-response to an anti-TNFα inhibitor, an IL-17 inhibitor or a Janus kinase (JAK) inhibitor is not an exclusion. Participants who previously discontinued ustekinumab for intolerance or inadequate response may be enrolled into the guselkumab cohort. Patients who previously discontinued guselkumab due to intolerance may be enrolled into the ustekinumab cohort. Participants who previously discontinued tildrakizumab or risankizumab due to intolerance may be enrolled into either cohort.\n- Has other inflammatory disease that might confound the evaluation of benefit from ustekinumab or guselkumab therapy, including but not limited to moderate to severe inflammatory bowel disease, systemic lupus erythematosus, or Lyme disease.\n- Has active uveitis within 12 weeks prior to the first administration of study intervention."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Ustekinumab Steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 28 by baseline age groups.","definition_or_measurement_approach":"Measurement: observed steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 28, analysed by baseline age groups."}
- {"endpoint_text":"- Ustekinumab ACR Pedi 30 response at Week 24.","definition_or_measurement_approach":"Measurement: proportion of participants achieving ACR Pedi 30 response at Week 24 according to American College of Rheumatology Pediatric criteria."}
- {"endpoint_text":"- Guselkumab Steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 28 by baseline age groups.","definition_or_measurement_approach":"Measurement: observed steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 28, analysed by baseline age groups."}
- {"endpoint_text":"- Guselkumab ACR Pedi 30 response at Week 24.","definition_or_measurement_approach":"Measurement: proportion of participants achieving ACR Pedi 30 response at Week 24 according to American College of Rheumatology Pediatric criteria."}
Secondary endpoints
- {"endpoint_text":"- PK – Ustekinumab Steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 52 by baseline age groups","definition_or_measurement_approach":"Measurement: observed steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 52, by baseline age groups."}
- {"endpoint_text":"- PK – Guselkumab Steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 52 by baseline age groups.","definition_or_measurement_approach":"Measurement: observed steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 52, by baseline age groups."}
- {"endpoint_text":"- Efficacy – Ustekinumab ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52.","definition_or_measurement_approach":"Measurement: ACR Pedi 30 response assessed at specified weeks (4, 8, 12, 16, 52) per ACR Pedi criteria."}
- {"endpoint_text":"- Efficacy – Ustekinumab ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52.","definition_or_measurement_approach":"Measurement: ACR Pedi 50 and ACR Pedi 70 responses assessed at specified weeks per ACR Pedi criteria."}
- {"endpoint_text":"- Efficacy – Ustekinumab Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24.","definition_or_measurement_approach":"Measurement: time (in days/weeks) from baseline to first achievement of ACR Pedi 30 within Week 24."}
- {"endpoint_text":"- Efficacy – Ustekinumab Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, and 52.","definition_or_measurement_approach":"Measurement: change from baseline in cJADAS and JADAS scores at specified weeks."}
- {"endpoint_text":"- Efficacy – Ustekinumab Change from baseline in PASI score at Week 24 among the participants with ≥3% BSA psoriatic involvement and a PGA psoriasis score of ≥2 (mild) at baseline.","definition_or_measurement_approach":"Measurement: change from baseline in PASI score at Week 24 among participants meeting baseline psoriasis criteria (≥3% BSA and PGA ≥2)."}
- {"endpoint_text":"- Efficacy – Guselkumab ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52.","definition_or_measurement_approach":"Measurement: ACR Pedi 30 response assessed at specified weeks for guselkumab cohort."}
- {"endpoint_text":"- Efficacy – Guselkumab ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52.","definition_or_measurement_approach":"Measurement: ACR Pedi 50 and 70 responses at specified weeks for guselkumab cohort."}
- {"endpoint_text":"- Efficacy – Guselkumab Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24.","definition_or_measurement_approach":"Measurement: time from baseline to first achievement of ACR Pedi 30 through Week 24."}
- {"endpoint_text":"- Efficacy – Guselkumab Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, and 52.","definition_or_measurement_approach":"Measurement: change from baseline in cJADAS and JADAS scores at specified weeks for guselkumab cohort."}
- {"endpoint_text":"- Efficacy – Guselkumab Change from baseline in PASI score at Week 24 among the participants with ≥3% BSA psoriatic involvement and a PGA psoriasis score of ≥2 (mild) at baseline.","definition_or_measurement_approach":"Measurement: change from baseline in PASI at Week 24 among participants meeting baseline psoriasis criteria."}
- {"endpoint_text":"- Safety – Ustekinumab The occurrences and type of AEs, SAEs, and reasonably related AEs.","definition_or_measurement_approach":"Measurement: incidence and types of adverse events (AEs), serious adverse events (SAEs), and events deemed reasonably related to study drug through safety reporting."}
- {"endpoint_text":"- Safety –Guselkumab The occurrences and type of AEs, SAEs, and reasonably related AEs.","definition_or_measurement_approach":"Measurement: incidence and types of AEs, SAEs, and reasonably related events for guselkumab cohort."}
- {"endpoint_text":"- Immunogenicity – Ustekinumab The incidence of antibodies to ustekinumab/guselkumab (including peak titers) through Week 52 and Week 68.","definition_or_measurement_approach":"Measurement: incidence of anti-drug antibodies (including peak titers) through Weeks 52 and 68."}
- {"endpoint_text":"- Immunogenicity –Guselkumab The incidence of antibodies to ustekinumab/guselkumab (including peak titers) through Week 52 and Week 68.","definition_or_measurement_approach":"Measurement: incidence of anti-drug antibodies (including peak titers) through Weeks 52 and 68 for guselkumab cohort."}
Recruitment
- Planned Sample Size
- 28
- Recruitment Window Months
- 49
- Consent Approach
- Informed consent is provided by the parent/legal guardian; assent obtained from children as appropriate (age-specific assent forms documented). Age-specific informed consent and subject information materials are provided (child, adolescent, parental/legal guardian, withdrawal, pregnant partner, 'turning 18' materials). Documents and ICF/assent versions are available in country/language-specific versions (examples submitted include French, Spanish, German, Polish).
Methods
- Patient recruitment activities conducted by IQVIA Limited (role listed as 'Patient recruitment' in sponsor third-party duties).
- Central laboratory and specialist vendor support (Labcorp Central Laboratory Services SARL / Labcorp Central Laboratory Services LP) and other vendor support for study operations as listed in third-party roles (no explicit public recruitment channels described in the submission).
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 28
Denmark
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 21-07-2024
- Processing Time Days
- 59
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Odense University Hospital
- Department Name
- HC Andersen Childrens Hospital
- Principal Investigator Name
- Anne Estmann
- Principal Investigator Email
- anne.estmann@rsyd.dk
- Contact Person Name
- Anne Estmann
- Contact Person Email
- anne.estmann@rsyd.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- Department of Pediatrics
- Principal Investigator Name
- Mia Glerup
- Principal Investigator Email
- miagleru@rm.dk
- Contact Person Name
- Mia Glerup
- Contact Person Email
- miagleru@rm.dk
Italy
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 60
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
- Department Name
- UO Reumatologia Pediatrica
- Principal Investigator Name
- Achille Marino
- Principal Investigator Email
- achille.marino@asst-pini-cto.it
- Contact Person Name
- Achille Marino
- Contact Person Email
- achille.marino@asst-pini-cto.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- UOC Pediatria
- Principal Investigator Name
- Giovanni Filocamo
- Principal Investigator Email
- giovanni.filocamo@policlinico.mi.it
- Contact Person Name
- Giovanni Filocamo
- Contact Person Email
- giovanni.filocamo@policlinico.mi.it
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- U.O. Reumatologia
- Principal Investigator Name
- Silvia Magni Manzoni
- Principal Investigator Email
- silvia.magnimanzoni@opbg.net
- Contact Person Name
- Silvia Magni Manzoni
- Contact Person Email
- silvia.magnimanzoni@opbg.net
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Reumatologia Pediatrica
- Principal Investigator Name
- Marco Cattalini
- Principal Investigator Email
- marco.cattalini@unibs.it
- Contact Person Name
- Marco Cattalini
- Contact Person Email
- marco.cattalini@unibs.it
- Site Name
- IRCCS Istituto Giannina Gaslini
- Department Name
- UOC Reumatologia e Malattie Autoinfiammatorie
- Principal Investigator Name
- Silvia Rosina
- Principal Investigator Email
- silviarosina@gaslini.org
- Contact Person Name
- Silvia Rosina
- Contact Person Email
- silviarosina@gaslini.org
Netherlands
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 17-07-2024
- Processing Time Days
- 55
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- rheumatology
- Principal Investigator Name
- Philomine van Pelt
- Principal Investigator Email
- p.vanpelt@erasmusmc.nl
- Contact Person Name
- Philomine van Pelt
- Contact Person Email
- p.vanpelt@erasmusmc.nl
France
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 17-07-2024
- Processing Time Days
- 55
- Number Of Sites
- 5
- Number Of Participants
- 1
Sites
- Site Name
- Bicetre Hospital
- Department Name
- Pediatrcs
- Principal Investigator Name
- Linda ROSSI
- Principal Investigator Email
- linda.rossi@aphp.fr
- Contact Person Name
- Linda ROSSI
- Contact Person Email
- linda.rossi@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Pediatrics
- Principal Investigator Name
- Alexandra DESDOITS
- Principal Investigator Email
- desdoits-a@chu-caen.fr
- Contact Person Name
- Alexandra DESDOITS
- Contact Person Email
- desdoits-a@chu-caen.fr
- Site Name
- CHRU De Nancy
- Department Name
- Pediatrics
- Principal Investigator Name
- Irene LEMELLE
- Principal Investigator Email
- i.lemelle@chru-nancy.fr
- Contact Person Name
- Irene LEMELLE
- Contact Person Email
- i.lemelle@chru-nancy.fr
- Site Name
- Hopital Des Enfants
- Department Name
- Pediatrics
- Principal Investigator Name
- Christine PAJOT
- Principal Investigator Email
- pajot.c@chu-toulouse.fr
- Contact Person Name
- Christine PAJOT
- Contact Person Email
- pajot.c@chu-toulouse.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Pediatrics
- Principal Investigator Name
- Diego URBINA
- Principal Investigator Email
- diego.urbina@ap-hm.fr
- Contact Person Name
- Diego URBINA
- Contact Person Email
- diego.urbina@ap-hm.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 57
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Asklepios Klinik Sankt Augustin GmbH
- Department Name
- Pediatric department
- Principal Investigator Name
- Gerd Horneff
- Principal Investigator Email
- g.horneff@asklepios.com
- Contact Person Name
- Gerd Horneff
- Contact Person Email
- g.horneff@asklepios.com
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- SPZ Rheumatologie
- Principal Investigator Name
- Kirsten Minden
- Principal Investigator Email
- kirsten.minden@charite.de
- Contact Person Name
- Kirsten Minden
- Contact Person Email
- kirsten.minden@charite.de
- Site Name
- Schoen Klinik Hamburg Eilbek
- Department Name
- Rheumatology
- Principal Investigator Name
- Ivan Foeldvari
- Principal Investigator Email
- foeldvari@t-online.de
- Contact Person Name
- Ivan Foeldvari
- Contact Person Email
- foeldvari@t-online.de
Spain
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 17-07-2024
- Processing Time Days
- 55
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Raumatology
- Principal Investigator Name
- Antonio Mera Varela
- Principal Investigator Email
- antonio.mera.varela@sergas.es
- Contact Person Name
- Antonio Mera Varela
- Contact Person Email
- antonio.mera.varela@sergas.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Raumatology
- Principal Investigator Name
- Berta Paula Magallares Lopez
- Principal Investigator Email
- bmagallares@santpau.cat
- Contact Person Name
- Berta Paula Magallares Lopez
- Contact Person Email
- bmagallares@santpau.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Mireia Lopez Corbeto
- Principal Investigator Email
- mireia.lopez@vallhebron.cat
- Contact Person Name
- Mireia Lopez Corbeto
- Contact Person Email
- mireia.lopez@vallhebron.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Rheumatology
- Principal Investigator Name
- Lucia Lacruz Perez
- Principal Investigator Email
- lacruz_lucper@gva.es
- Contact Person Name
- Lucia Lacruz Perez
- Contact Person Email
- lacruz_lucper@gva.es
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Raumatology
- Principal Investigator Name
- Maria Rosa Roldan Molina
- Principal Investigator Email
- rosa.roldan@hotmail.es
- Contact Person Name
- Maria Rosa Roldan Molina
- Contact Person Email
- rosa.roldan@hotmail.es
Poland
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 17-07-2024
- Processing Time Days
- 55
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Department Name
- Oddział Kardiologii i Reumatologii dla Dzieci
- Principal Investigator Name
- Elżbieta Smolewska
- Principal Investigator Email
- e.smolewska@wp.pl
- Contact Person Name
- Elżbieta Smolewska
- Contact Person Email
- e.smolewska@wp.pl
- Site Name
- Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
- Department Name
- Ośrodek Badań Klinicznych
- Principal Investigator Name
- Anna Gruenpeter
- Principal Investigator Email
- anna.gruenpeter@gmail.com
- Contact Person Name
- Anna Gruenpeter
- Contact Person Email
- anna.gruenpeter@gmail.com
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Principal Investigator Name
- Piotr Gietka
- Principal Investigator Email
- piotr.gietka@spartanska.pl
- Contact Person Name
- Piotr Gietka
- Contact Person Email
- piotr.gietka@spartanska.pl
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Eresearchtechnology Inc.
- Responsibilities
- eCoA, eLearning, Investigator Meeting, Custom Reports (as listed in sponsor duties)
- Name
- IQVIA Limited
- Responsibilities
- Multiple study support roles including patient recruitment (listed as 'Patient recruitment') and other listed duties
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- Responsibilities listed under sponsor duties (code 3)
- Name
- Medidata Solutions Inc.
- Responsibilities
- Responsibilities listed under sponsor duties (code 7)
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4; contact zara.saeed@labcorp.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties: code 15; value: eCoA, eLearning, Investigator Meeting, Custom Reports","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: 4; contact zara.saeed@labcorp.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: 3; contact IRTHelp@almacgroup.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"sponsorDuties: code 15; value: Ancillary supplies","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7; contact Matthew.RILEY@3ds.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,12,15(value: Patient recruitment),2,5,6,8; contact eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4; contact srebarch@its.jnj.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- STELARA 90 mg solution for injection in pre-filled syringe / STELARA 45 mg solution for injection (ustekinumab)
- Active Substance
- USTEKINUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation numbers present in submission (examples: EU/1/08/494/001 and EU/1/08/494/004 associated with STELARA products)
- Dose Levels
- 45 mg; 90 mg (product strengths present in submission)
- Frequency
- Referenced in PK endpoints as 12-week dosing interval for ustekinumab
- Maximum Dose
- 90 mg
- Investigational Product Name
- Guselkumab (Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL)
- Active Substance
- GUSELKUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Product entries present (prodAuthStatus values in submission); product described as Guselkumab 100 mg/mL
- Dose Levels
- 100 mg/mL formulation; dosing also referenced as mg/kg (maxTotalDoseAmount 1.3 mg/kg in one product entry)
- Frequency
- Referenced in PK endpoints as dosing interval of 4 or 8 weeks for guselkumab
- Maximum Dose
- 100 mg/mL (product); 1.3 mg/kg (as indicated in one product entry)
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