Phase 3
N=1,672
Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03587805 ↗Enrolled (actual)
1,672
Serious AEs
9.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268) — 8119 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tralokinumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268) |
8119 | — |
| SECONDARY 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 |
47.3; 48.5; 48.6; 47.1; 48.7; 46.8 | — |
| SECONDARY 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 |
77.0; 75.2; 75.1; 74.6; 74.1; 73.0 | — |
Summary
The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.
Eligibility Criteria
Inclusion Criteria
- Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or TRA-WEI-0015-I.
- Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
- Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
- Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
Exclusion Criteria
- Any condition that required permanent discontinuation of trial treatment in the parent trial.
- More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline).
- Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
- Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline.
- Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.
- Clinically significant infection within 4 weeks prior to baseline.
- A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
- Tuberculosis requiring treatment within 12 months prior to screening.
- Known primary immunodeficiency disorder.
Data sourced from ClinicalTrials.gov (NCT03587805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.