Phase 2
N=215
Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03562377 ↗Enrolled (actual)
215
Serious AEs
2.8%
Results posted
Mar 2021
Primary outcome: Primary: Positive Anti-tetanus Response at Week 16 — 80; 73 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tralokinumab (Drug); Placebo (Drug); Tdap vaccine (Biological); Meningococcal vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Anti-tetanus Response at Week 16 |
80; 73 | — |
| PRIMARY Positive Anti-meningococcal Response at Week 16 |
74; 64 | — |
| SECONDARY Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 |
33; 21 | 0.049 sig |
| SECONDARY Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16. |
52; 39 | 0.057 |
| SECONDARY Number of AEs. |
112; 133 | — |
| SECONDARY Presence of Anti-drug Antibodies (ADA). |
2; 4; 1; 2; 103; 97 | — |
Summary
The purpose of this trial is to test if treatment with the trial drug, tralokinumab, can affect the body's immune response to vaccines. The trial will also evaluate the efficacy of tralokinumab when it is given concomitantly with vaccines.
The trial includes a screening period of 2 to 6 weeks, a treatment period of 16 weeks (Weeks 0 to 16), and a 14-week off-treatment follow-up period for the assessment of safety (Weeks 16 to 30). Eligible subjects may transfer to an open-label, long-term trial at Week 16 or later.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 54 years
- Diagnosis of AD as defined by Hanifin and Rajka (1980) criteria for AD
- History of AD for ≥1 year
- Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
- AD involvement of ≥10% body surface area at screening and baseline
- An EASI score of ≥12 at screening and 16 at baseline
- An IGA score of ≥3 at screening and at baseline
- Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation
Exclusion Criteria
- Subjects for whom administration of the meningococcal vaccine provided in this trial is contraindicated or medically inadvisable, according to local label of the vaccine
- Subjects for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this trial is contraindicated or medically inadvisable, according to local label of the vaccine
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment
- Use of tanning beds or phototherapy within 6 weeks prior to randomization
- Treatment with systemic immunosuppressive/immunomodulating medications and/or systemic corticosteroids within 4 weeks prior to randomization
- Treatment with the topical medications topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomization
- Receipt of any vaccine (except influenza virus vaccines) within 3 months prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening
- Receipt of any marketed (i.e. immunoglobulin, anti-IgE) or investigational biologic agent, including dupilumab
- History of any active skin infection within 1 week prior to randomization
- History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomization
Data sourced from ClinicalTrials.gov (NCT03562377). 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.