Tralokinumab for Dupilumab Failures

Phase 4

Active, not recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: tralokinumab

• Registration Number: NCT06773455
• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-11
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-02-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tralokinumab	tralokinumab	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving IGA 0 or 1 at week 16	16 Weeks

Trial Locations

Locations (1)

Psoriasis Treatment Center of New Jersey; 🇺🇸 East Windsor, New Jersey, United States