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

Phase 1

• Conditions: Atopic Dermatitis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-005976-36-SE
• Lead Sponsor: Karolinska Universitetssjukhuset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-04
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 42

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This trial will deeply phenotype a small cohort of AD patients at baseline<br>and under tralokinumab treatment and thereby identify candidate<br>biomarkers that predict response to tralokinumab treatment. The<br>primary endpoint is the change in BSA after 16 weeks of tralokinumab<br>treatment as measured by 360° imaging.;Secondary Objective: To understand which molecular signature is associated with clinical<br>response to tralokinumab.;Primary end point(s): Change from baseline in Body Surface Area (BSA) at 16 weeks of<br>tralokinumab treatment as measured by 360° imaging.;Timepoint(s) of evaluation of this end point: Week 16