Clinical trial • Phase III • Dermatology

TRALOKINUMAB for Atopic dermatitis | Moderate-to-severe atopic dermatitis

Phase III trial of TRALOKINUMAB for Atopic dermatitis | Moderate-to-severe atopic dermatitis.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Atopic dermatitis | Moderate-to-severe atopic dermatitis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
07-10-2024

Trial design

Randomised, open-label, placebo (the placebo presentation is a pre-filled syringe containing the same excipients in the same amounts as the imp) + topical corticosteroids; active comparator: tralokinumab (adtralza 150 mg solution for injection in pre-filled syringe) + topical corticosteroids. dose: adtralza product presentation 150 mg pre-filled syringe (no dosing schedule specified in provided documents).-controlled Phase III trial in Czechia, Denmark, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo (The placebo presentation is a pre-filled syringe containing the same excipients in the same amounts as the IMP) + topical corticosteroids; active comparator: tralokinumab (Adtralza 150 mg solution for injection in pre-filled syringe) + topical corticosteroids. Dose: Adtralza product presentation 150 mg pre-filled syringe (no dosing schedule specified in provided documents).
Target Sample Size
79
Trial Duration For Participant
150

Eligibility

Recruits 79 paediatric patients.

Pregnancy Exclusion
23. Pregnant, breastfeeding, or lactating female subjects.
Vulnerable Population
The trial includes infants (6 months to <2 years) and children (2 to <12 years). Informed consent must be signed and dated (inclusion criterion 1) by the parent(s) or legal guardian(s). Assent materials and age-specific information sheets are provided (e.g. assent brochure/forms for children aged 6-11 years, subject information for children turning 12 years, and parental ICFs for infants 6 months to 2 years). Participant-facing materials and ICF/assent documents are prepared for caregivers and subjects and are available in local language versions as indicated in the trial documents. The investigator assesses ability of subject and caregiver(s) to comply with visits and procedures.

Inclusion criteria

  • {"criterion_text":"- 1. Signed and dated informed consent\n- 10. A Child Worst Itch NRS average score* of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score* of ≥4 (subjects aged <6 years at screening) during the week prior to baseline. * Average Child Worst Itch NRS and average Scratch ObsRO at baseline will be calculated from daily assessments of each score during the 7 days immediately preceding baseline. Scores must be provided on at least 4 days during the 7 days immediately preceding baseline to calculate the baseline average score. For subjects who do not provide scores on at least 4 days during the 7 days immediately preceding the planned baseline date, randomization or assignment to treatment should be postponed until this requirement is met, but without exceeding the 4 weeks’ maximum duration for screening\n- 11. Subject and caregiver(s) are able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator\n- 12. Female subjects who have been assessed by the investigator to be of childbearing potential (i.e. post-menarcheal and not permanently sterile, see Section 10.3.1 for details) and who are sexually active must agree to use a highly effective* method of contraception to prevent pregnancy during the clinical trial and until 16 weeks (5 half-lives) after discontinuation of treatment with IMP. *: A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year), such as the below (see Section 10.3.2 for details): • Sexual 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]). • Bilateral tubal occlusion. • Intrauterine device (IUD). • Intrauterine hormone-releasing system (IUS). • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable). • Vasectomized azoospermic partner (given that the subject is monogamous)\n- 2. Age 6 months to <12 years at screening, with the following exceptions for countries outside of North America (US/Canada): • Age 2 years to <12 years at screening in the EU and the UK. • Age 6 years to <12 years at screening in South-Korea.\n- 3. Body weight ≥9 kg at screening\n- 4. Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD (27)\n- 5. History of AD for: • ≥12 months for subjects aged ≥6 years at screening. • ≥3 months for subjects aged 6 months to <6 years at screening\n- 6. Documented inadequate response* to mid-strength** TCS within 6 months before the screening visit. * Inadequate response to topical treatment is defined as either of the below: • Failure to achieve and maintain remission or low disease activity state despite topical AD treatment. • Documented systemic treatment for AD within 6 months before the screening visit. ** Mid-strength TCS is defined as below, see Section 10.4 for details: • Europe: TCS classified as ‘Potent (Class 3)’ or ‘Very potent (Class 4)’. • US: TCS classified as ‘Moderate (Class 4)’, ‘High (Class 2 or 3)’, or ‘Ultra-high (Class 1)’\n- 7. AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD\n- 8. An EASI score of ≥16 at screening and baseline\n- 9. An IGA score of ≥3 at screening and baseline"}

Exclusion criteria

  • {"criterion_text":"- 1.Treatment with the following topical medications within 1 week prior to baseline: • TCS. • TCI. • Topical PDE-4 inhibitor. •Topical JAK inhibitors.\n- 10. Eczema as part of a genodermatosis syndrome, such as Netherton’s syndrome, hyper IgE syndrome, Wiskott–Aldrich syndrome, etc.\n- 11. Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.\n- 12. Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoals within 2 weeks before the baseline visit*. *: If the infection resolves, the screening period may be prolonged after approval by the sponsor's medical expert.\n- 13. History of malignancy at any time before the baseline visit.\n- 14. History of anaphylaxis following any biological therapy.\n- 15. History of immune complex disease.\n- 16. Active or suspected endoparasitic infections (including helminthic infections), or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization. Evaluation will be according to local guidelines as per local standard of care.\n- 17. History of past or current tuberculosis or other mycobacterial infection.\n- 18. History of known HIV infection, confirmed HIV seropositivity at the screening visit, or the subject taking antiretroviral medications as determined by medical history and/or verbal report from the caregiver(s).\n- 19. Established diagnosis of a primary immunodeficiency disorder (e.g. severe combined immunodeficiency, Wiskott–Aldrich syndrome, DiGeorge syndrome, X-linked agammaglobulinemia, common variable immunodeficiency) or secondary immunodeficiency. Subjects suspected to have immunodeficiency based on their clinical presentation (history of invasive opportunistic infections, e.g. tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, chronic mucocutaneous candidiasis, etc. or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the investigator) will also be excluded from the trial.\n- 2. Treatment with bleach baths within 1 week prior to baseline.\n- 20. History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.\n- 21. Known or suspected hypersensitivity to any component of the IMP.\n- 22. Any other medical or psychological condition which in the investigator’s opinion could: • Affect the safety of the subject throughout the trial. • Influence the findings of the trial. • Impede the subject’s ability to complete the trial. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, immunological, and psychiatric disorders, major physical impairment, drug or alcohol dependency, or unwillingness or lacking ability to understand and comply with the trial related procedures.\n- 23. Pregnant, breastfeeding, or lactating female subjects.\n- 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the upper limit of normal (ULN) at screening.\n- 25. Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during the screening period, which in the opinion of the investigator, may put the subject at risk because of their participation in the trial, may influence the results of the trial, or may affect the subject’s ability to complete the entire duration of the trial.\n- 26. Current participation in any other interventional clinical trial.\n- 27. Previously randomized or assigned to treatment in this clinical trial.\n- 28. Previously randomized in any clinical trials with tralokinumab.\n- 29. Planned major surgical procedure during the subject's participation in this trial.\n- 3.Treatment with the following immunomodulatory medications within 4 weeks prior to baseline: • Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors). • Systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery).\n- 30. Subjects with severe needle phobia or a history of vasovagal reactions following injections or blood withdrawal, or subjects who are unwilling to comply with the assessments of the trial.\n- 31. Inability or unwillingness to receive IMP injections at randomization and throughout the trial.\n- 32. Subjects who are legally institutionalized.\n- 33. Employees at the trial site*, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals. *: When the trial site is a department at a hospital, this exclusion criterion only applies to family members of employees in the department that participates in the trial.\n- 4. Use of tanning beds or phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen+ultraviolet A [PUVA]) within 4 weeks prior to baseline.\n- 5.Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit. Subjects should preferably be brought up-to-date on their vaccinations according to local vaccination programs before being randomized in the trial.\n- 6. Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab): • Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. • Dupilumab: within 12 weeks prior to baseline. • Other biologics: within 8 weeks or 5 half-lives, whichever is longer, prior to baseline.\n- 7. Treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 3 months or 5 half-lives, whichever is longer, prior to baseline.\n- 8. Receipt of blood products within 4 weeks prior to screening.\n- 9. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- IGA 0/1 at Week 16","definition_or_measurement_approach":""}
  • {"endpoint_text":"- EASI75 at Week 16","definition_or_measurement_approach":""}

Other endpoints

  • {"endpoint_text":"- Investigate the impact of tralokinumab+TCS on skin colonization with Staphylococcus aureus and stratum corneum lipid composition (an indirect measure of skin barrier function) in subjects aged 2 to <12 years.","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
True, recruitment materials include referral emails and electronic materials; participant-facing trial eDiary guidance and digital subject diary documents are provided (eDiary subject-facing guides), indicating use of digital tools and electronic communication for participant engagement.
Planned Sample Size
79
Recruitment Window Months
44
Consent Approach
Informed consent must be signed and dated by the parent(s) or legal guardian(s). Age-appropriate assent is used for children (assent forms and brochures for ages 6-11 years are provided). There are specific ICFs for parents of infants (6 months to <2 years) and for parents of children 2-11 years, and processes for subjects turning 12 years. Subject information, ICF and assent materials are available in multiple local languages as provided in trial documents (examples include German, Polish, Portuguese, Spanish, Dutch, Italian, Romanian, Croatian and English). The investigator assesses the ability of subject and caregiver(s) to comply with trial visits and procedures.

Methods

  • Referral by healthcare professionals (HCP referral letters and emails; HCP-targeted materials K2_* Referral Letter and Email, Eligibility Criteria Leaflets). Materials are country-specific (e.g. K1/K2 documents for DE, NL, PL, PT, RO, HR, BE, IE, ES, IT, CZ).
  • Participant-facing posters and flyers for recruitment (K2_* Flyer for Participant; Recruitment Poster) targeted at potential participants/caregivers.
  • Information leaflets and general information to participants and caregivers (K2_* General Information, Information About the Clinical Trial) provided to parents/caregivers and subjects.
  • Greeting cards, HCP core story and referral postcards for HCP engagement (K1/K2 HCP materials).
  • Use of email referral channels (referral emails) as part of recruitment materials.

Geography

Total Number Of Sites
47
Total Number Of Participants
112

Czechia

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
32
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Kozni ambulance Kutna Hora s.r.o.
Department Name
Dermatology
Contact Person Name
Lucie Petru
Contact Person Email
Petru.L@seznam.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Dermatology
Contact Person Name
Marie Selerova
Contact Person Email
marie.selerova@nnj.agel.cz

Denmark

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
31
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Region Hovedstaden
Department Name
Dept of Dermatology
Contact Person Name
Kristina Ibler
Site Name
Odense University Hospital
Department Name
Department of Dermatovenerology and allergy Center
Contact Person Name
Charlotte Gotthard Mortz
Contact Person Email
charlotte.moertz@rsyd.dk

Poland

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
24-03-2025
Processing Time Days
186
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Klinika Ambroziak Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Bartlomiej Kwiek
Contact Person Email
principal@klinikaambroziak.pl
Site Name
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Department Name
Alergologist
Contact Person Name
Bernadetta Majorek-Olechowska
Contact Person Email
bernadettaolechowska@gmail.com
Site Name
Dermedic Jacek Zdybski
Department Name
Dermatology
Contact Person Name
Pior Parcheta
Contact Person Email
piotr.parcheta@zdybski.pl
Site Name
ROYALDERM Agnieszka Nawrocka
Department Name
Dermatology
Contact Person Name
Witold Owczarek
Contact Person Email
witold.owczarek@dermedicus.pl
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
Dermatology
Contact Person Name
Adam Reich
Contact Person Email
adi_medicalis@go2.pl
Site Name
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-badawczy spolka cywilna
Department Name
Dermatology
Contact Person Name
Pawel Brzewski
Contact Person Email
brzewski@sgd-polska.com
Site Name
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
Department Name
Dermatology
Contact Person Name
Aleksandra Lesiak
Contact Person Email
lesiak_ola@interia.pl
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Aleksandra Okuniewska
Contact Person Email
a.okuniewska@pihouse.pl

Portugal

Earliest CTIS Part Ii Submission Date
15-08-2024
Latest Decision Or Authorization Date
17-03-2025
Processing Time Days
214
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Dermatology and Venereology
Contact Person Name
Susana Machado
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Dermatology
Contact Person Name
Rita Pimenta
Contact Person Email
ritapimenta@campus.ul.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Dermatology
Contact Person Name
Joana Gomes

Romania

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
24-03-2025
Processing Time Days
199
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Centrul Medical Unirea S.R.L.
Department Name
Allergology
Contact Person Name
Daniela Maria Dragus
Site Name
Spitalul Clinic Căi Ferate Iași
Department Name
Dermatology
Contact Person Name
Daciana-Elena Brănișteanu
Contact Person Email
debranisteanu@yahoo.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Compartiment Clinic Dermatologie Copii
Contact Person Name
Carmen Sălăvăstru

Germany

Earliest CTIS Part Ii Submission Date
23-09-2024
Latest Decision Or Authorization Date
20-03-2025
Processing Time Days
178
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Dermatologie
Contact Person Name
Galina Balakirski
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Sektion Dermatologie
Contact Person Name
Sebastian Volc
Site Name
Klinische Forschung Osnabrueck
Department Name
KLIFOs Klinische Forschung
Contact Person Name
Sylvia Pauser
Contact Person Email
sylvia.pauser@klifos.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Dermatologie
Contact Person Name
Stefan Beissert
Site Name
Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
Department Name
Hautklinik
Contact Person Name
Andreas Kleinheinz
Site Name
MVZ Corius Potsdam GmbH
Department Name
Dermatologische Praxis
Contact Person Name
Khusru Asadullah
Contact Person Email
khusru.asadullah@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Hautklinik
Contact Person Name
Petra Staubach

Netherlands

Earliest CTIS Part Ii Submission Date
26-09-2024
Latest Decision Or Authorization Date
24-03-2025
Processing Time Days
179
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Dermatology
Contact Person Name
Marlies deGraaf
Contact Person Email
M.deGraaf-10@umcutrecht.nl

Belgium

Earliest CTIS Part Ii Submission Date
18-09-2024
Latest Decision Or Authorization Date
20-03-2025
Processing Time Days
183
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
Dermatology
Contact Person Name
Arjen Nikkels
Contact Person Email
af.nikkels@chuliege.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Dermatology
Contact Person Name
Sofie De Schepper
Contact Person Email
sofie.deschepper@uzgent.be
Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Dermatology
Contact Person Name
Pamela El Nemnon
Contact Person Email
pamela.elnemnom@hubruxelles.be
Site Name
UZ Leuven
Department Name
Dermatology
Contact Person Name
Caroline Colmant
Contact Person Email
caroline.colmant@uzleuven.be

Spain

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
18-03-2025
Processing Time Days
169
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Hospital General Universitario Dr. Balmis
Department Name
Dermatology
Contact Person Name
Laura Berbegal de Gracia
Contact Person Email
lauraberbegal@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Dermatology
Contact Person Name
Raul De Lucas-Laguna
Contact Person Email
rauldelucas@gmail.com
Site Name
Hospital Universitario De Fuenlabrada
Department Name
Dermatology
Contact Person Name
Almudena Hernandez Nuñez
Contact Person Email
ahernandezn@salud.madrid.org
Site Name
Hospital General Universitario De Valencia
Department Name
Dermatology
Contact Person Name
Altea Esteve Martinez
Contact Person Email
aemder@gmail.com

Ireland

Earliest CTIS Part Ii Submission Date
23-09-2024
Latest Decision Or Authorization Date
06-08-2025
Processing Time Days
317
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Children's Health Ireland
Department Name
Research & Innovation, Chrildren`s Health Ireland (CHI)
Contact Person Name
Alan Irvine
Contact Person Email
IRVINEA@tcd.ie
Site Name
Cork University Hospital
Department Name
Infant research centre
Contact Person Name
Michelle Murphy
Contact Person Email
michelle.murphy@ucc.ie

Croatia

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
19-08-2025
Processing Time Days
326
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Poliklinika Dermaplus
Department Name
Dermatovenerology, pediatry, allergology and clinical immunology
Contact Person Name
Lena Kotrulja
Contact Person Email
lena.kotrulja@gmail.com
Site Name
Klinika Za Djecje Bolesti Zagreb
Department Name
Department of Pediatric Dermatology
Contact Person Name
Suzana Ožanić Bulić
Contact Person Email
Suzana.OzanicBulic@kdb.hr
Site Name
Specijalna Bolnica Medico
Department Name
Dermatology
Contact Person Name
Sandra Peternel
Contact Person Email
sandra.peternel@medico.hr
Site Name
Clinical Hospital Centre Rijeka
Department Name
Dermatology
Contact Person Name
Larisa Prpić Massari
Contact Person Email
larisa.prpic@medri.uniri.hr
Site Name
Djecja bolnica Srebrnjak
Department Name
Pulmonology and Allergology for infants and young children
Contact Person Name
Mirjana Turkalj
Contact Person Email
mturkalj@bolnica-serbrnjak.hr
Site Name
Poliklinika Solmed d.o.o.
Department Name
Dermatology
Contact Person Name
Iva Blajić
Contact Person Email
ivablajic@hotmail.com

Italy

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
470
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
S.O.D. Clinica di Dermatologia
Contact Person Name
Oriana Simonetti
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. Dermatologia
Contact Person Name
Valeria Boccaletti
Contact Person Email
valeria.boccaletti@gmail.com
Site Name
Azienda Ospedaliera di Padova
Department Name
Dermatologia e Venereologia
Contact Person Name
Anna Belloni Fortina
Contact Person Email
anna.bellonifortina@unipd.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Dermatologia
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
U.O.C. Dermatologia
Contact Person Name
Dario Francesco D’Urso
Contact Person Email
dariofrancesco.durso@opbg.net

Sponsor

Primary sponsor

Full Name
LEO Pharma A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
codes:1,11,12,13,15 (Monitoring and other local national activities),4,5,6,8; contact CTIS email CTIS-Biotech@iconplc.com

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes:1,11,12,13,15 (Monitoring and other local national activities),4,5,6,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Adtralza 150 mg solution for injection in pre-filled syringe
Active Substance
TRALOKINUMAB
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised (marketing authorisation EU/1/21/1554/001)
Starting Dose
150 mg (product presentation 150 mg pre-filled syringe)
Maximum Dose
600 mg
Investigational Product Name
The placebo presentation is a pre-filled syringe containing the same excipients in the same amounts as the IMP.
Modality
Other
Combination Treatment
Yes

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