Summary
EudraCT Number:2021-005573-12
Sponsor's Protocol Code Number:LP0162-1335
National Competent Authority:Czechia - SUKL
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2022-04-20
Trial results
A. Protocol Information
A.1Member State ConcernedCzechia - SUKL
A.2EudraCT number2021-005573-12
A.3Full title of the trial
A single (assessor) blinded, randomised, parallel-group, monotherapy trial to evaluate the pharmacokinetic and safety of tralokinumab in children (age 2 to <12 years) with moderate-to-severe atopic dermatitis.

Randomizované hodnocení, s paralelními skupinami, zaslepené pro hodnotitele k vyhodnocení farmakokinetiky a bezpečnosti monoterapie tralokinumabu u dětí (věk 2-12 let) se středně těžkou až těžkou atopickou dermatitidou
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Tralokinumab monotherapy for children with moderate-to-severe atopic dermatitis.
TRAPEDS 1 (TRAlokinumab PEDiatric trial no. 1)

Monoterapie tralokinumabem pro děti se středně těžkou až těžkou atopickou dermatitidou
A.3.2Name or abbreviated title of the trial where available
TRAPEDS 1
A.4.1Sponsor's protocol code numberLP0162-1335
A.7Trial is part of a Paediatric Investigation Plan Yes
A.8EMA Decision number of Paediatric Investigation PlanP/096/2022
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorLEO Pharma A/S
B.1.3.4CountryDenmark
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportLEO Pharma A/S
B.4.2CountryDenmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationLEO Pharma A/S
B.5.2Functional name of contact pointGlobal Regulatory Affairs
B.5.3 Address:
B.5.3.1Street AddressIndustriparken 55
B.5.3.2Town/ cityBallerup
B.5.3.3Post codeDK-2750
B.5.3.4CountryDenmark
B.5.4Telephone number+4544945855
B.5.6E-mail[email protected]
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameTralokinumab
D.3.2Product code CAT-354
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNTralokinumab
D.3.9.1CAS number 1044515-88-9
D.3.9.3Other descriptive nameCAT-354
D.3.9.4EV Substance CodeSUB189645
D.3.10 Strength
D.3.10.1Concentration unit mg/l milligram(s)/litre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number150
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Atopic dermatitis
E.1.1.1Medical condition in easily understood language
Eczema
E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level LLT
E.1.2Classification code 10003639
E.1.2Term Atopic dermatitis
E.1.2System Organ Class 100000004858
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To establish the PK profile after multiple SC administrations of tralokinumab in children with moderate-to-severe AD.
E.2.2Secondary objectives of the trial
To assess the safety and tolerability of multiple SC administrations of tralokinumab in children with moderate-to-severe AD.
E.2.3Trial contains a sub-study Yes
E.2.3.1Full title, date and version of each sub-study and their related objectives
There is a substudy for assessing skin microbiology and markers of skin barrier function:
-Skin swabs will be done (determination of abundance of S.Aureus)
-Skin tape stripping will be done (determination of skin barrier function)
E.3Principal inclusion criteria
- Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
- Age 2 to <12 years.
- Body weight at baseline:
- ≥9 kg for children aged 2 to <6 years at screening.
- ≥17 kg for children aged 6 to <12 years at screening.
- History of AD for:
- ≥ 3 months for children aged 2 to <6 years at screening.
- ≥ 12 months for children aged 6 to <12 years at screening.
- History of TCS and/or TCI treatment failure (due to inadequate response
or intolerance) or subjects for whom these topical AD treatments are
medically inadvisable.
- AD involvement of ≥10% body surface area at screening and baseline.
- An EASI score of ≥16 at screening and at baseline.
- An IGA score of ≥3 at screening and at baseline.
- Emollient twice daily (or more) for at least 14 days prior to baseline.
E.4Principal exclusion criteria
- Active dermatologic conditions that may confound the diagnosis of AD or
would interfere with assessment of treatment.
- Treatment with topical PDE-4 inhibitor within 2 weeks prior to
randomization.
- Treatment with the following immunomodulatory medications or bleach
baths within 4 weeks prior to baseline:
- Systemic immunosuppressive/immunomodulating drugs (e.g.
methotrexate, cyclosporine, azathioprine, mycophenolate mofetil,
JAK inhibitors).
- Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or
intranasal delivery).
- 3 or more bleach baths during any week within the 4 weeks.
- 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.
- Other biologics (including dupilumab): within 3 months or 5 halflives,
whichever is longer, prior to baseline.
- Active chronic or acute infection requiring treatment with systemic
antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before
the baseline visit.
- History of malignancy at any time before the baseline visit.
- History of anaphylaxis following any biological therapy.
- History of immune complex disease.
- Active or suspected endoparasitic infections.
- History of past or current tuberculosis or other mycobacterial infection.
- Established diagnosis of a primary immunodeficiency disorder.
E.5 End points
E.5.1Primary end point(s)
Primary Endpoints (PK parameters):
- Trough concentration (Ctrough) at Week 16.
- Maximum serum concentration (Cmax) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).*
- Area under the curve (AUC) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).*
- Time to maximum serum concentration (Tmax) between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).*

*The endpoint will also be summarised by dosing interval within the low dose level
E.5.1.1Timepoint(s) of evaluation of this end point
Primary Endpoints (PK parameters):
- Trough concentration (Ctrough) at Week 16.
- Maximum serum concentration (Cmax) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).*
- Area under the curve (AUC) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).*
- Time to maximum serum concentration (Tmax) between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).*

*The endpoint will also be summarised by dosing interval within the low dose level
E.5.2Secondary end point(s)
To assess the safety and tolerability of multiple SC administrations of tralokinumab in children with moderate-to-severe AD.
To evaluate the efficacy of tralokinumab on severity and extent of AD, and on patient-reported outcomes, in children with moderate-to-severe AD.
E.5.2.1Timepoint(s) of evaluation of this end point
Secondary Endpoints:
- Number of treatment emergent adverse events in the initial treatment period (Week 0-Week 16).
- Anti-drug antibodies (status) in the initial treatment period (Week 0-Week 16).
- Number of treatment emergent adverse events in the open-label treatment period (Week 16-Week 68).
- Anti-drug antibodies (status) in the open-label treatment period (Week 16-Week 68)

- Change in SCORAD from Week 0-Week 68.
- Change in POEM from Week 0-Week 68.
- Change in EASI from Week 0 to Week 68.

E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others Yes
E.6.13.1Other scope of the trial description
Sub study for skin microbiology and skin barrier function



E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind Yes
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned3
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA12
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Czechia
France
Netherlands
Spain
United Kingdom
E.8.7Trial has a data monitoring committee Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
LVLS
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months4
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years3
E.8.9.2In all countries concerned by the trial months4
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1Number of subjects for this age range: 53
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) Yes
F.1.1.5.1Number of subjects for this age range: 53
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
The study participants are children age 2 to <12 years old. The children may give assent to participate in the trial as per local laws. Consent will be given by the child's parents/guardians.
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state10
F.4.2 For a multinational trial
F.4.2.1In the EEA 39
F.4.2.2In the whole clinical trial 53
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
None
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-09-02
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-04-20
P. End of Trial
P.End of Trial StatusOngoing