Atopic Dermatitis
Conditions
Brief summary
24-week study of 20 atopic dermatitis patients who have been treated with dupilumab will receive Tralokinumab 600mg at week 0 followed by 300mg Q2W for 24 weeks.
Interventions
DRUGtralokinumab
600mg at week 0 followed by 300mg Q2W for 24 weeks
Sponsors
Psoriasis Treatment Center of Central New Jersey
LEO Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female adult ≥ 18 years of age; * All participants must have prior treatment with dupilumab for atopic dermatitis meeting one of the following conditions: * Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab for at least 12 weeks. * Participants who stopped dupilumab treatment due to intolerance or AEs to the drug may enter the study with no required prior length of dupilumab treatment. AE's must be resolved prior to 1st tralokinumab dose. * Females of childbearing potential (FCBP) must have a negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. Subject is a candidate for systemic therapy. * Subject must be in general good health as judged by the Investigator, based on medical history, physical examination. * Able and willing to give written informed consent prior to performance of any study-related procedures.
Exclusion criteria
* Subjects with previous exposure to tralokinumab. * Known or suspected hypersensitivity to tralokinumab or any of its excipients. * Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating. * Use of tanning beds or phototherapy within 4 weeks of baseline * Use of systemic therapies (systemic steroids, cyclosporine, oral JAK inhibitors etc.) for atopic dermatitis within 4 weeks * Patient non-compliant with Dupixent dosing based on investigator discretion. * Any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving IGA 0 or 1 at week 16 | 16 Weeks |
Countries
United States
Outcome results
None listed