Tralokinumab for Eczema

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Psoriasis Treatment Center of Central New Jersey

Must be taking: Dupilumab

Must not be taking: Systemic steroids, Cyclosporine

Disqualifiers: Tralokinumab exposure, Uncontrolled major disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults over 18 with atopic dermatitis previously treated with dupilumab but needing alternative therapy can join. They must be in good health, not pregnant or lactating, and willing to use contraception. Excluded are those recently on systemic eczema therapies, non-compliant with Dupixent, using tanning/phototherapy, or have uncontrolled diseases.

Inclusion Criteria

I am not pregnant and will use birth control if there's a risk of getting pregnant.

I am eligible for treatment that affects my whole body.

I have been treated with dupilumab for my skin condition.

Exclusion Criteria

I haven't used any systemic treatments for eczema in the last 4 weeks.

Patient non-compliant with Dupixent dosing based on investigator discretion

I haven't used tanning beds or undergone phototherapy in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tralokinumab 600mg at week 0 followed by 300mg every 2 weeks for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tralokinumab

Trial Overview The trial tests Tralokinumab as an alternative for atopic dermatitis patients who didn't respond well to Dupilumab. Participants receive a starting dose of 600mg followed by 300mg every two weeks for six months to evaluate its effectiveness and safety.

Participant Groups

Group I: Tralokinumab Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Psoriasis Treatment Center of Central New Jersey

Lead Sponsor

Trials

18

Recruited

530+

LEO Pharma

Industry Sponsor

Trials

275

Recruited

189,000+

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD