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Monoclonal Antibodies

Tralokinumab for Atopic Dermatitis (INJECZTRA Trial)

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 at week 16
Awards & highlights

INJECZTRA Trial Summary

This trial is testing a new drug for people with moderate to severe atopic dermatitis. The drug will be given as a shot, and the trial will evaluate how well it works and if it is safe.

Eligible Conditions
  • Atopic Dermatitis

INJECZTRA Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
At least 75% reduction in Eczema Area and Severity Index (EASI75) at Week 16
Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16
Secondary outcome measures
Therapeutic procedure
Presence of treatment-emergent anti-drug antibodies (ADA) from baseline to Week 16

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

INJECZTRA Trial Design

1Treatment groups
Experimental Treatment
Group I: Tralokinumab subcutaneous dosing with Device AExperimental Treatment1 Intervention
An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.
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
188,315 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
53 Previous Clinical Trials
9,965 Total Patients Enrolled

Frequently Asked Questions

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

What is the efficacy of Tralokinumab in other medical applications?

"Presently, there are 3 ongoing clinical trials for Tralokinumab, 2 of which are in Phase 3. Though a few of the investigations for Tralokinumab are based in Verdun, Quebec, there are a total of 275 sites running clinical trials for Tralokinumab."

Answered by AI

How many individuals are allowed to be a part of this research project?

"That is accurate. The website clinicaltrials.gov has the latest information regarding this clinical trial. According to the site, this trial was posted on 1/13/2022 and was last edited on 9/30/2022. They are looking for a total of 120 participants that will be spread out over 27 different sites."

Answered by AI

In how many medical clinics is this study being conducted?

"There are 27 sites currently enrolling patients for this trial. Some of the sites are located in Farmington, Brighton and Los Angeles. If you enroll, it would be best to choose the clinical trial site nearest you to limit travel."

Answered by AI

Has Tralokinumab been cleared by the FDA?

"Tralokinumab has multiple rounds of safety data, as well as some efficacy data, so it received a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tralokinumab Administered With Device A in Adults and Adolescents With Moderate-to-severe Atopic Dermatitis
2022. "Tralokinumab Administered With Device A in Adults and Adolescents With Moderate-to-severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05194540.
~42 spots leftby Apr 2025
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