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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
Must not have
Subjects must not enter the trial if they have active subtypes of hand eczema other than AHE that are considered to be the predominant cause of the current hand eczema including: Active irritant contact dermatitis, Active allergic contact dermatitis, Active protein contact dermatitis/contact urticaria, Active hyperkeratotic hand eczema, Active vesicular hand eczema (pompholyx), Active dermatologic conditions that may confound the diagnosis of AD or AHE, or that would interfere with the assessment of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) to week 16
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My hand eczema is not caused by allergies, irritants, or other skin conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) to week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
IGA-AHE score of 0 (clear) or 1 (almost clear)
Secondary study objectives
Change in WPAI+CIQ:AHE domain scores
Having a decrease in HECSI of at least 75% (HECSI-75)
Percentage change in DLQI score
+3 more

Side effects data

From 2019 Phase 3 trial • 802 Patients • NCT03131648
24%
Viral upper respiratory tract infection
18%
Dermatitis atopic
9%
Bronchitis
9%
Injection site reaction
5%
Back pain
5%
Conjunctivitis
5%
Pruritus
4%
Nasopharyngitis
4%
Influenza
3%
Headache
1%
Conjunctivitis allergic
1%
Asthma
1%
Pneumonia
1%
Pneumothorax spontaneous
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Period - Tralokinumab Q4W
Open-label Period - Tralokinumab Q2W + Optional TCS
Maintenance Period - Tralokinumab Q2W
Initial Period - Tralokinumab Q2W
Initial Period - Placebo
Maintenance Period - Placebo
Maintenance Period - Placebo - Tralokinumab Naive
Safety Follow-up

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~6190

Find a Location

Who is running the clinical trial?

LEO PharmaLead Sponsor
271 Previous Clinical Trials
188,470 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
9,909 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
~243 spots leftby Nov 2026
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