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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%
Oropharyngeal pain
2%
Conjunctivitis allergic
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
269 Previous Clinical Trials
188,498 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
53 Previous Clinical Trials
9,936 Total Patients Enrolled
~41 spots leftby Jun 2025
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