Tralokinumab for Dupilumab Failures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2025-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tralokinumab

Group Type EXPERIMENTAL

tralokinumab

Intervention Type DRUG

600mg at week 0 followed by 300mg Q2W for 24 weeks

Interventions

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tralokinumab

600mg at week 0 followed by 300mg Q2W for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No