Tralokinumab for Dupilumab Failures

Psoriasis Treatment Center of Central New Jersey

Status and phase

Active, not recruiting

Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: tralokinumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06773455

ETC05

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.