Clinical Trials Register

Summary
EudraCT Number:	2020-005976-36
Sponsor's Protocol Code Number:	KTDIIS01
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-03-04
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Sweden - MPA

A.2

EudraCT number

2020-005976-36

A.3

Full title of the trial

An investigator-initiated, open label trial to correlate efficacy of
tralokinumab in subjects with atopic dermatitis to molecular signatures
(PRECision in TRAlokinumab therapy)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Trial to investigate which atopic dermatitis patients will respond to the biologic therapy tralokinumab

A.3.2

Name or abbreviated title of the trial where available

PRECTRA

A.4.1

Sponsor's protocol code number

KTDIIS01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Karolinska Universitetssjukhuset
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Dermagnostix R&D
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Karolinska Universitetssjukhuset
B.5.2	Functional name of contact point	Maria Bradley
B.5.3	Address:
B.5.3.1	Street Address	Eugeniavägen
B.5.3.2	Town/ city	Stockholm
B.5.3.4	Country	Sweden
B.5.6	E-mail	maria.bradley@ki.se

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tralokinumab
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Atopic Dermatitis

E.1.1.1

Medical condition in easily understood language

Atopic Dermatitis

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

This trial will deeply phenotype a small cohort of AD patients at baseline
and under tralokinumab treatment and thereby identify candidate
biomarkers that predict response to tralokinumab treatment. The
primary endpoint is the change in BSA after 16 weeks of tralokinumab
treatment as measured by 360° imaging.

E.2.2

Secondary objectives of the trial

To understand which molecular signature is associated with clinical
response to tralokinumab.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Confirmed diagnosis of AD defined by UK Working Criteria with an EASI
score ≥ 16, age 18-80 years, body weight ≥ 40 kg and ≤ 160 kg, signed
informed consent from patient.

E.4

Principal exclusion criteria

Pregnancy or breast feeding, women of child-bearing potential unless
they use effective contraception during the study and for 4 weeks after
study completion or discontinuation, history or presence of epilepsy,
significant neurological disorders, cerebrovascular attacks or ischemia,
myocardial infarction or cardiac arrhythmia which requires drug therapy,
evidence of severe renal dysfunction or significant hepatic disease,
history of lymphoproliferative disorders, patients who are considered
potentially unreliable or where it is envisaged the patient may not
consistently attend scheduled study visits, inability or unwillingness to
undergo repeated venipuncture or skin punch biopsies, any
immuneactive
systemic treatment within 4 weeks or 5 biologic half-lifes
(whichever is longer) or immune-active topical treatment within one
week before inclusion, history of clinical significant medical condition or
any other reason, which the investigator determines, would interfere with the subject´s participation in this study or would make the subject an unsuitable candidate to receive study drug or would put the subject at risk by participating in the study.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in Body Surface Area (BSA) at 16 weeks of
tralokinumab treatment as measured by 360° imaging.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16

E.5.2

Secondary end point(s)

EASI 75 score at weeks 4, 16 and 32 (Eczema Area and Severity Index)
The proportion of subjects who achieve at least a 75% reduction in the
EASI score at weeks 4, 16, and 32 compared to week 0 (Baseline). EASI
scores range from 0 to 72, with higher scores reflecting greater disease
severity. Erythema, edema, lichenification, and excoriations/erosions
are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of
the body: head, trunk, upper limbs, and lower limbs. Degree of
involvement on each of the 4 anatomic regions is scored on a scale of 0
to 6. The total qualitative score is multiplied by the degree of
involvement for each anatomic region and then multiplied by a constant
and summed to yield the EASI score.
EASI 50 score at weeks 4, 16 and 32 (Eczema Area and Severity Index)
The proportion of subjects who achieve at least a 50% reduction in the
EASI score at weeks 4, 16, and 32 compared to week 0 (Baseline).
EASI 90 score at weeks 4, 16 and 32 (Eczema Area and Severity Index)
The proportion of subjects who achieve at least a 90% reduction in the
EASI score at weeks 4, 16 and 32 compared to week 0 (Baseline).
Change from baseline in EASI score at weeks 4, 16 and 32 (Eczema Area
and Severity Index)
Change from baseline in SCORAD score at weeks 4, 16 and 32 (Scoring
Atopic Dermatitis score)
Change from baseline in Investigator Global Assessment (IGA) at weeks
4, 16 and 32
Definition of the IGA 5-point scale:
1. Clear – no inflammatory signs of AD (Grade 0)
2. Almost clear: just perceptible erythema and just perceptible
papulation/infiltration (Grade 1)
3. Mild disease: mild erythema and mild papulation/infiltration (Grade
2)
4. Moderate disease: moderate erythema and moderate
papulation/infiltration (Grade 3)
5. Severe disease: severe erythema and severe papulation/infiltration
(Grade 4)
Change from baseline in the Dermatology Life Quality Index (DLQI) Total
Score at weeks 4, 16 and 32
DLQI is a simple, compact, and practical questionnaire for use in a
dermatology clinical setting to assess limitations related to the impact of
skin disease. The instrument contains ten items dealing with the
participant's skin. With the exception of Item Number 7, the participant
responds on a four-point scale, ranging from "Very Much" (score 3) to
"Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part
item, the first part of which ascertains whether the participant's
skinprevented them from working or studying (Yes or No, scores 3 or 0
respectively), and if "No," then the participant is asked how much the
skin has been a problem at work or study over the past week, with
response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item
scores, which has a possible range of 0 to 30, with 30 corresponding to
the worst quality of life, and 0 corresponding to the best.
Change from baseline in Pruritus Visual Analog Scale (VAS) Score at
weeks 4, 16 and 32
VAS are used to measure the amount of itching and discomfort a
participant experiences. All VAS values range from 0 to 10 (0 = no
pruritus, 10 = worst pruritus imaginable) and are reported on each visit.
Maximum itch intensity in the last three days before the visit is asked
for. Change from baseline is calculated for the VAS scale, where change
= visit value − baseline value.
Change from baseline in the Montgomery – Åsberg depression rating
scale (MADRS) at weeks 4, 16 and 32
The MADRS was developed and validated to measure the severity of
depressive episodes. It contains 10 items that each yield from 0-6, thus
60 is the highest possible score. 7-19 points argue for mild depression,
20-34 for moderate, and >34 for severe depression.

E.5.2.1

Timepoint(s) of evaluation of this end point

week 2, 4, 8, 12, 16, 20, 24, 28, 32

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

Treatment as needed and decided by treating physician

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-05-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-23

P. End of Trial
P.	End of Trial Status	Ongoing

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