← Back to Search

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
No Placebo-Only Group
Pivotal Trial

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%
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%
Intervertebral disc protrusion
1%
Pneumothorax spontaneous
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
271 Previous Clinical Trials
188,736 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
10,175 Total Patients Enrolled
~35 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top