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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

Summary

This trial tests if tralokinumab injections can safely and effectively treat moderate-to-severe atopic dermatitis in people aged 12 and older. The medication works by reducing skin inflammation through blocking a specific protein. Tralokinumab has been evaluated for its efficacy and safety in treating moderate-to-severe atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16
Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16

Side effects data

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tralokinumab subcutaneous dosing by an autoinjectorExperimental 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
~6190

Find a Location

Who is running the clinical trial?

LEO PharmaLead Sponsor
270 Previous Clinical Trials
188,513 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
10,161 Total Patients Enrolled
~37 spots leftby Sep 2025
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