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Monoclonal Antibodies

Tralokinumab for Atopic Hand Eczema (ADHAND Trial)

Phase 3

Recruiting

Research Sponsored by LEO Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of atopic dermatitis (AD) as by the Hanifin and Rajka (1980) criteria for AD

AD involvement of at least one body location other than the hands and wrists at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16 to week 32

Awards & highlights

ADHAND Trial Summary

This trial tests if tralokinumab is safe & effective to treat atopic hand eczema. Participants will get injections every 2 weeks up to 40 weeks, with 3 phone visits.

Who is the study for?

Adults over 18 with moderate-to-severe atopic hand eczema, unresponsive to or unsuitable for topical treatments, and a history of atopic dermatitis. Participants must have had eczema on their hands for more than 3 months or recurrent episodes and other body areas affected. They should not have used certain therapies before joining the trial.Check my eligibility

What is being tested?

The study tests Tralokinumab's safety and effectiveness against placebo in treating atopic hand eczema over 32 weeks. Initially, participants receive either Tralokinumab or placebo biweekly for 16 weeks; afterwards, all get Tralokinumab for another 16 weeks.See study design

What are the potential side effects?

Tralokinumab may cause side effects such as inflammation reactions, infections due to immune system changes, injection site reactions like redness or pain, eye issues (like conjunctivitis), headaches, and fatigue.

ADHAND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with atopic dermatitis.

Select...

My skin condition affects at least one body part besides my hands and wrists.

Select...

My hand eczema has lasted over 3 months or returned twice in the last year despite avoiding irritants.

Select...

I am 18 years old or older.

Select...

I have had Alzheimer's disease for at least 1 year.

ADHAND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16 to week 32

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16 to week 32

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 to week 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in WPAI+CIQ:AHE domain scores

Having a decrease in HECSI of at least 50% (HECSI-50)

Having a decrease in HECSI of at least 75% (HECSI-75)

+12 more

Side effects data

From 2019 Phase 3 trial • 802 Patients • NCT03131648

25%

Viral upper respiratory tract infection

22%

Dermatitis atopic

Conjunctivitis

Injection site reaction

Headache

Pruritus

Back pain

Oropharyngeal pain

Conjunctivitis allergic

Bronchitis

Asthma

Acute myocardial infarction

Influenza

Nasopharyngitis

Tendonitis

100%

80%

60%

40%

20%

Study treatment Arm

Open-label Period - Tralokinumab Q2W + Optional TCS

Initial Period - Tralokinumab Q2W

Initial Period - Placebo

Maintenance Period - Tralokinumab Q2W

Maintenance Period - Tralokinumab Q4W

Maintenance Period - Placebo

Maintenance Period - Placebo - Tralokinumab Naive

Safety Follow-up

ADHAND Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TralokinumabExperimental Treatment1 Intervention

Tralokinumab is administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period)

Group II: Placebo + tralokinumabPlacebo Group1 Intervention

Placebo is administered for 16 weeks (double-blinded period) prior to roll-over to a 16 weeks open-label period where tralokinumab is administered

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tralokinumab

2016

Completed Phase 3

~4520

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

LEO PharmaLead Sponsor

269 Previous Clinical Trials

188,261 Total Patients Enrolled

Medical ExpertStudy DirectorLEO Pharma

53 Previous Clinical Trials

9,699 Total Patients Enrolled

Media Library

Tralokinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05958407 — Phase 3

Atopic Dermatitis Research Study Groups: Tralokinumab, Placebo + tralokinumab

Atopic Dermatitis Clinical Trial 2023: Tralokinumab Highlights & Side Effects. Trial Name: NCT05958407 — Phase 3

Tralokinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05958407 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical research still open?

"This research effort, which was initially posted on August 31st 2023 and last edited a fortnight later, is not presently looking for any new patients. Nevertheless, there are 233 other clinical trials recruiting participants at this juncture."

Answered by AI

Has Tralokinumab received the necessary regulatory approval to be used in medical treatments?

"Tralokinumab has been tested through a Phase 3 trial, so there is evidence of its efficacy and safety. Consequently, our team assigned it a score of three on the risk rating scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

2023. "A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05958407.

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