Clinical trial • Phase III • Immunology
APREMILAST for Juvenile psoriatic arthritis
Phase III trial of APREMILAST for Juvenile psoriatic arthritis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Juvenile psoriatic arthritis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 19-01-2024
- First CTIS Authorization Date
- 07-03-2024
Trial design
Randomised, placebo (tablet or liquid suspension) matching apremilast; subjects randomized 2:1 to oral apremilast (tablet or liquid suspension) or placebo (tablet or liquid suspension).-controlled Phase III trial across 36 sites in Spain, Belgium, Poland and others.
- Randomised
- Yes
- Comparator
- Placebo (tablet or liquid suspension) matching apremilast; subjects randomized 2:1 to oral apremilast (tablet or liquid suspension) or placebo (tablet or liquid suspension).
- Target Sample Size
- 16
- Trial Duration For Participant
- 434
Eligibility
Recruits 16 paediatric patients.
- Vulnerable Population
- Pediatric subjects aged 5 to <18 years are included and 'isVulnerablePopulationSelected' is true. Age-specific assent and consent documents are provided (adolescent assent and child assent forms, parental/legal guardian informed consent forms, pregnancy ICFs). Multiple language versions and age-stratified ICF/assent documents are available in the document repository.
Inclusion criteria
- {"criterion_text":"- Male or Female subjects 5 to less than 18 years of age at the time of randomization.\n- Confirmed diagnosis of JPsA according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration: •Arthritis and psoriasis, OR •Arthritis with at least 2 of the following: dactylitis; nail pitting or onycholysis; psoriasis in a first-degree relative\n- Active disease: at least 3 active joints\n- Inadequate response (at least 2 months) or intolerance to at least 1 DMARD, (which may include MTX or biologic agents).\n- Other protocol-defined inclusion criteria apply."}
Exclusion criteria
- {"criterion_text":"- Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.\n- Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).\n- Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include: rthritis in an HLA-B27-positive male with arthritis onset after 6 years of age; Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative; History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart; Presence of systemic JIA\n- Other protocol-defined exclusion criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of participants achieving ACR Pedi 30 from baseline (week 0) to week 16","definition_or_measurement_approach":"ACR Pedi 30 response from baseline to week 16 (American College of Rheumatology Pediatric criteria)."}
Secondary endpoints
- {"endpoint_text":"- Change in subject's assessment of pain (a)","definition_or_measurement_approach":"Change from baseline to week 16 in subject/parent assessment of pain measured by visual analogue scale (VAS)."}
- {"endpoint_text":"- Number of participants achieving ACR Pedi 20/50/70/90 (a)","definition_or_measurement_approach":"ACR Pedi 20/50/70/90 responses at week 16 (American College of Rheumatology Pediatric response criteria)."}
- {"endpoint_text":"- Change in Childhood Heath Assessment Questionnaire (CHAQ) (a)","definition_or_measurement_approach":"Change from baseline to week 16 in CHAQ score (Childhood Health Assessment Questionnaire)."}
- {"endpoint_text":"- Change in Juvenile Arthritis Disease Activity Score (JADAS) (a)","definition_or_measurement_approach":"Change from baseline to week 16 in JADAS (Juvenile Arthritis Disease Activity Score)."}
- {"endpoint_text":"- Refer to protocol for fully list of secondary endpoints.","definition_or_measurement_approach":"See protocol for full list and definitions."}
- {"endpoint_text":"- PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a)","definition_or_measurement_approach":"PASI-75 response (Psoriasis Area Severity Index ≥75% improvement) at week 16 for subjects with baseline psoriasis BSA ≥ 3%."}
- {"endpoint_text":"- Number of participants who experience PsA flares (a)","definition_or_measurement_approach":"PsA flares defined as ≥ 30% worsening in at least 3 of 6 ACR-Pedi core variables with ≥ 30% improvement in not more than 1 of 6 ACR-Pedi core variables (assessed at week 16)."}
Other endpoints
- {"endpoint_text":"- Estimate impact on HRQoL in pediatric subjects with JPsA","definition_or_measurement_approach":"Health-related quality of life measures (HRQoL) as specified in protocol (e.g., disease-specific or generic HRQoL instruments)."}
- {"endpoint_text":"- Estimate safety and tolerability of apremilast compared with placebo in pediatric subjects with JPsA","definition_or_measurement_approach":"Safety and tolerability assessments including adverse events, clinical labs, vital signs, and other safety measures per protocol."}
- {"endpoint_text":"- Characterize pharmacokinetics of apremilast in pediatric subjects with JPsA","definition_or_measurement_approach":"Pharmacokinetic sampling and analysis to characterize apremilast PK in pediatric subjects as defined in protocol."}
- {"endpoint_text":"- Evaluate taste and acceptability of apremilast tablet and suspension in pediatric subjects with JPsA","definition_or_measurement_approach":"Assessments of taste and acceptability of tablet and suspension formulations (patient/parent-reported measures) as specified in protocol."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 16
- Recruitment Window Months
- 82
- Consent Approach
- Informed consent obtained from parent/legal guardian; assent obtained from children/adolescents as appropriate. Age-specific ICF/assent documents exist (child assent forms for younger children, adolescent assent forms, parental/legal guardian ICFs, pregnancy ICFs). Documents available in multiple language versions (examples in repository include EN, FR, NL, DE, ES, PT, IT, LT, RO, GR).
Methods
- Study-specific flyers and leaflets distributed at sites and clinics
- Peer-to-peer letters to clinicians (physician-to-physician recruitment letters)
- GP/Dr-to-Dr referral letters
- Patient information leaflets and site-specific recruitment brochures
- Study animation and study video brochure (multimedia digital materials)
- Site outreach and local pediatric rheumatology clinic recruitment (country/site-specific materials present)
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 51
Spain
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 778
- Number Of Sites
- 6
- Number Of Participants
- 6
Sites
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Department Name
- Servicio de Reumatología
- Principal Investigator Name
- Jordi Anton Lopez
- Principal Investigator Email
- jordi.anton@sjd.es
- Contact Person Name
- Jordi Anton Lopez
- Contact Person Email
- jordi.anton@sjd.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Servicio de Reumatología
- 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 Universitario De Canarias
- Department Name
- Servicio de Reumatología
- Principal Investigator Name
- Juan Jose Bethencourt Baute
- Principal Investigator Email
- jbetbau@gobiernodecanarias.org
- Contact Person Name
- Juan Jose Bethencourt Baute
- Contact Person Email
- jbetbau@gobiernodecanarias.org
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Servicio de Reumatología
- Principal Investigator Name
- Juan Carlos Nieto-González
- Principal Investigator Email
- juancarlos.nietog@gmail.com
- Contact Person Name
- Juan Carlos Nieto-González
- Contact Person Email
- juancarlos.nietog@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Reumatología
- Principal Investigator Name
- Estefania Moreno Ruzafa
- Principal Investigator Email
- reumaped@vallhebron.cat
- Contact Person Name
- Estefania Moreno Ruzafa
- Contact Person Email
- reumaped@vallhebron.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de Reumatología
- Principal Investigator Name
- Alina-Lucica Boteanu
- Principal Investigator Email
- alinalucica.boteanu@salud.madrid.org
- Contact Person Name
- Alina-Lucica Boteanu
- Contact Person Email
- alinalucica.boteanu@salud.madrid.org
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 04-07-2025
- Processing Time Days
- 521
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- Benoit Florkin
- Principal Investigator Email
- Benoit.florkin@chrcitadelle.be
- Contact Person Name
- Benoit Florkin
- Contact Person Email
- Benoit.florkin@chrcitadelle.be
- Site Name
- Het Ziekenhuisnetwerk Antwerpen
- Department Name
- Rheumatology
- Principal Investigator Name
- Rik Joos
- Principal Investigator Email
- Rik.Joos@zna.be
- Contact Person Name
- Rik Joos
- Contact Person Email
- Rik.Joos@zna.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- Joke Dehoorne
- Principal Investigator Email
- joke.dehoorne@uzgent.be
- Contact Person Name
- Joke Dehoorne
- Contact Person Email
- joke.dehoorne@uzgent.be
Poland
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 783
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Rheumatology
- Principal Investigator Name
- Joanna Wójtowicz
- Principal Investigator Email
- agnieszka.paradowska-gorycka@spartanska.pl
- Contact Person Name
- Joanna Wójtowicz
- Contact Person Email
- agnieszka.paradowska-gorycka@spartanska.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Department Name
- Rheumatology
- Principal Investigator Name
- Elżbieta Smolewska
- Principal Investigator Email
- j.kazmierska@csk.umed.pl
- Contact Person Name
- Elżbieta Smolewska
- Contact Person Email
- j.kazmierska@csk.umed.pl
- Site Name
- Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie
- Department Name
- Rheumatology
- Principal Investigator Name
- Zbigniew Żuber
- Principal Investigator Email
- reumatologia@dzieciecyszpital.pl
- Contact Person Name
- Zbigniew Żuber
- Contact Person Email
- reumatologia@dzieciecyszpital.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 778
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Asklepios Klinik Sankt Augustin GmbH
- Department Name
- Center of General Paediatrics and Neonatology
- 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
- Children's university hospital Charite, Campus Virchow, SPZ
- 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
- Technische Universitat Dresden
- Department Name
- Children's Hospital at Technical Unversity Dresden
- Principal Investigator Name
- Normi Brueck
- Principal Investigator Email
- Normi.Brueck@uniklinikum-dresden.de
- Contact Person Name
- Normi Brueck
- Contact Person Email
- Normi.Brueck@uniklinikum-dresden.de
- Site Name
- Hamburger Zentrum für Kinder- und Jugendrheumatologie
- Department Name
- Kinder- und Jugendrheumatologie
- Principal Investigator Name
- Ivan Foeldvari
- Principal Investigator Email
- foeldvari@t-online.de
- Contact Person Name
- Ivan Foeldvari
- Contact Person Email
- foeldvari@t-online.de
Italy
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 780
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
- Department Name
- Pediatric rheumatology
- 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
- Giannina Gaslini Institute For Scientific Hospitalization And Care
- Department Name
- Pediatric rheumatology
- Principal Investigator Name
- Roberta Caorsi
- Principal Investigator Email
- robertacaorsi@gaslini.org
- Contact Person Name
- Roberta Caorsi
- Contact Person Email
- robertacaorsi@gaslini.org
- Site Name
- Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
- Department Name
- pediatric clinic
- Principal Investigator Name
- Luciana Breda
- Principal Investigator Email
- luciana.bredach@gmail.com
- Contact Person Name
- Luciana Breda
- Contact Person Email
- luciana.bredach@gmail.com
- Site Name
- Bambino Gesu Childrens Hospital
- Department Name
- Rheumatology
- 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
France
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 777
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- Heloise REUMAUX
- Principal Investigator Email
- heloise.reumaux@chu-lille.fr
- Contact Person Name
- Heloise REUMAUX
- Contact Person Email
- heloise.reumaux@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- Alexandre BELOT
- Principal Investigator Email
- alexandre.belot@chu-lyon.fr
- Contact Person Name
- Alexandre BELOT
- Contact Person Email
- alexandre.belot@chu-lyon.fr
Lithuania
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 778
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Pediatrijos centras
- Principal Investigator Name
- Skirmante Rusoniene
- Principal Investigator Email
- skirmante.rusoniene@santa.lt
- Contact Person Name
- Skirmante Rusoniene
- Contact Person Email
- skirmante.rusoniene@santa.lt
Austria
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 783
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
- Department Name
- Division of Paediatric and Adolescent Medicine
- Principal Investigator Name
- Christian Huemer
- Principal Investigator Email
- christian.huemer@lkhb.at
- Contact Person Name
- Christian Huemer
- Contact Person Email
- christian.huemer@lkhb.at
Greece
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 779
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Nosokomeio Paidon I Agia Sofia
- Department Name
- A University Pediatric Clinic, Pediatric Rheumatology Unit
- Principal Investigator Name
- Christina Kanaka-Gantenbein
- Principal Investigator Email
- chriskan@med.uoa.gr
- Contact Person Name
- Christina Kanaka-Gantenbein
- Contact Person Email
- chriskan@med.uoa.gr
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 3rd Department of Pediatrics
- Principal Investigator Name
- Lampros Fotis
- Principal Investigator Email
- lampros.fotis@outlook.com
- Contact Person Name
- Lampros Fotis
- Contact Person Email
- lampros.fotis@outlook.com
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- A Pediatric Clinic
- Principal Investigator Name
- Vasiliki Sgouropoulou
- Principal Investigator Email
- vsgouro@hotmail.com
- Contact Person Name
- Vasiliki Sgouropoulou
- Contact Person Email
- vsgouro@hotmail.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 780
- Number Of Sites
- 4
- Number Of Participants
- 3
Sites
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Servico de Reumatologia
- Principal Investigator Name
- Patrícia Pinto
- Principal Investigator Email
- patricia.pinto@ulsge.min-saude.pt
- Contact Person Name
- Patrícia Pinto
- Contact Person Email
- patricia.pinto@ulsge.min-saude.pt
- Site Name
- Unidade Local De Saude Do Alto Minho E.P.E.
- Department Name
- Servico de Reumatologia
- Principal Investigator Name
- Daniela Peixoto
- Principal Investigator Email
- helena.pires@blueclinical.pt
- Contact Person Name
- Daniela Peixoto
- Contact Person Email
- helena.pires@blueclinical.pt
- Site Name
- Centro Hospitalar De Lisboa Ocidental E.P.E.
- Department Name
- Serviço de Reumatologia
- Principal Investigator Name
- Filipa Mourão
- Principal Investigator Email
- afmourao@chlo.min-saude.pt
- Contact Person Name
- Filipa Mourão
- Contact Person Email
- afmourao@chlo.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Servico de Reumatologia
- Principal Investigator Name
- Filipa Oliveira Ramos
- Principal Investigator Email
- filipa.ramos@chln.min-saude.pt
- Contact Person Name
- Filipa Oliveira Ramos
- Contact Person Email
- filipa.ramos@chln.min-saude.pt
Romania
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 15-05-2026
- Processing Time Days
- 836
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca
- Department Name
- Pediatrics
- Principal Investigator Name
- Mihaela Nicoleta Sparchez
- Principal Investigator Email
- pediatrie2@spitcocluj.ro
- Contact Person Name
- Mihaela Nicoleta Sparchez
- Contact Person Email
- pediatrie2@spitcocluj.ro
- Site Name
- Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara
- Department Name
- Pediatrics
- Principal Investigator Name
- Otilia Marginean
- Principal Investigator Email
- secretariat@spitalcopiitm.ro
- Contact Person Name
- Otilia Marginean
- Contact Person Email
- secretariat@spitalcopiitm.ro
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 815
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Amsterdam UMC
- Department Name
- Pediatrics - Pediatric Rheumatology
- Principal Investigator Name
- J. Merlijn van den Berg
- Principal Investigator Email
- ctis@amsterdamumc.nl
- Contact Person Name
- J. Merlijn van den Berg
- Contact Person Email
- ctis@amsterdamumc.nl
- 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
- Site Name
- Wilhelmina Childrens Hospital
- Department Name
- Department of Pediatric Immunology and Rheumatology
- Principal Investigator Name
- Joost Swart
- Principal Investigator Email
- J.F.Swart@umcutrecht.nl
- Contact Person Name
- Joost Swart
- Contact Person Email
- J.F.Swart@umcutrecht.nl
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- sponsorDuties code: 3
- Name
- Excelya Greece CRO Single Member S.A.
- Responsibilities
- Administrative activities in Greece
- Name
- WCG Clinical Inc.
- Responsibilities
- Site Training Portal to provide training to investigators on the following assessments: Joint Count; PASI/BAS; Tanner Stages; C-SSRS
- Name
- QPS LLC
- Responsibilities
- sponsorDuties code: 4
- Name
- Cytel Inc.
- Responsibilities
- Independent Biostatics Group (Data Monitoring Committee)
Third parties
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Site Training Portal to provide training to investigators on the following assessments: Joint Count; PASI/BAS; Tanner Stages; C-SSRS","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"Administrative activities in Greece","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subject cost reimbursement for the following EU countries: Belgium, Netherlands, Germany, Spain and Greece","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Provision of equipment and ancillary supplies to clinical trial sites","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Central laboratory services (contact: ctasubmissions@labcorp.com)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Independent Biostatics Group (Data Monitoring Committee)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"Provision of equipment and ancillary supplies to clinical trial sites","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Back-up samples long term storage at end of study.","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Apremilast (ORAL SOLUTION)
- Active Substance
- APREMILAST
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation exists (prodAuthStatus 1, MIA number 108520 F)
- Maximum Dose
- 60 mg (max daily dose amount)
- Investigational Product Name
- Apremilast (FILM COATED TABLET / TABLETS)
- Active Substance
- APREMILAST
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation exists (prodAuthStatus 1, MIA number 108520 F)
- Maximum Dose
- 60 mg (max daily dose amount)
- Investigational Product Name
- Apremilast placebo product (10, 20 and 30 mg tablets and 5 mg/mL oral solution)
- Modality
- Other
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