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Long-Term Safety of Tralokinumab for Eczema

Phase 3
Waitlist Available
Research Sponsored by LEO Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 16 up to week 248
Awards & highlights

Study Summary

This trial will test the long-term safety of the drug tralokinumab.

Who is the study for?
This trial is for individuals with atopic dermatitis who have previously participated in certain tralokinumab trials and can self-administer the treatment. They must be using emollients regularly and have followed earlier trial protocols without safety issues that would risk further participation.Check my eligibility
What is being tested?
The ECZTEND trial is focused on assessing the long-term safety of a medication called tralokinumab, which is used to treat atopic dermatitis (a type of eczema).See study design
What are the potential side effects?
Potential side effects are not detailed here, but since this study evaluates long-term safety, it may include monitoring for any adverse reactions related to ongoing use of tralokinumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 16 up to week 248
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 16 up to week 248 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of adverse events from baseline through the last treatment visit (up to Week 268)
Secondary outcome measures
At least 75% reduction in Eczema Area and Severity Index (EASI75) relative to baseline in parent trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248

Side effects data

From 2019 Phase 3 trial • 802 Patients • NCT03131648
25%
Viral upper respiratory tract infection
22%
Dermatitis atopic
7%
Conjunctivitis
5%
Injection site reaction
4%
Headache
4%
Pruritus
3%
Back pain
2%
Conjunctivitis allergic
2%
Oropharyngeal pain
2%
Bronchitis
1%
Asthma
1%
Acute myocardial infarction
1%
Influenza
1%
Nasopharyngitis
1%
Tendonitis
100%
80%
60%
40%
20%
0%
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tralokinumab, all subjectsExperimental Treatment1 Intervention
Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266*: SC injection of tralokinumab maintenance dose. *The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tralokinumab
2016
Completed Phase 3
~4520

Find a Location

Who is running the clinical trial?

LEO PharmaLead Sponsor
268 Previous Clinical Trials
186,779 Total Patients Enrolled
Medical expertStudy DirectorLEO Pharma
3 Previous Clinical Trials
721 Total Patients Enrolled

Media Library

Tralokinumab Clinical Trial Eligibility Overview. Trial Name: NCT03587805 — Phase 3
Atopic Dermatitis Research Study Groups: Tralokinumab, all subjects
Atopic Dermatitis Clinical Trial 2023: Tralokinumab Highlights & Side Effects. Trial Name: NCT03587805 — Phase 3
Tralokinumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03587805 — Phase 3
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT03587805 — Phase 3

Frequently Asked Questions

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

In how many countries is this trial being conducted?

"To make participation as easy as possible for volunteers, this study is enrolling patients at 100 sites. These locations are situated in Surrey, Saint John's, Etobicoke and 100 other cities."

Answered by AI

Could you please tell me what the long-term effects of Tralokinumab are?

"Tralokinumab has been evaluated in Phase 3 trials, meaning that there is both some efficacy data and multiple rounds of safety data supporting its use. As such, our team has rated it as a 3 on our safety scale."

Answered by AI

What other similar studies exist for comparison?

"The first clinical study for Tralokinumab was sponsored by LEO Pharma in 2018. After the Phase 1 drug trial involving 1672 patients, the medication was approved for Phase 3 testing. As of now, there are 3 ongoing trials in 133 cities and 11 different countries."

Answered by AI

If so, could you please share the results of other Tralokinumab research?

"The first clinical trial for tralokinumab was conducted in 2018 by LEO Pharma. As of now, there have been 23 completed studies with 3 more trials underway. The majority of these trials take place in Surrey, British Columbia."

Answered by AI

Are there any vacant slots in this study for test subjects?

"Recruitment for this study has closed. The trial was first posted on September 18th, 2018 and was last edited on November 9th, 2020. There are currently 259 other trials recruiting patients with eczema and 3 other trials recruiting patients for Tralokinumab."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have been suffering for more than 10 years and nothing has helped.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
2018. "Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03587805.
All > Seborrheic Dermatitis > Atopic Dermatitis
~45 spots leftby Jun 2024
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