Atopic Dermatitis
Conditions
Interventions
Product Name: Tralokinumab
Pharmaceutical Form:
Sponsors
Karolinska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To understand which molecular signature is associated with clinical response to tralokinumab.;Primary end point(s): Change from baseline in Body Surface Area (BSA) at 16 weeks of tralokinumab treatment as measured by 360° imaging.;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 que | — |
Countries
Sweden
Contacts
Public ContactMaria Bradley
Karolinska Universitetssjukhuset
Outcome results
None listed