Trial Search Results
Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.
Stanford is currently accepting patients for this trial.
- Drug: Tralokinumab
- Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326,
-1334, -1339, -1341, -1342, or -1346.
- Complied with the clinical trial protocol in the parent trial to the satisfaction of
- 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
- Stable dose of emollient twice daily (or more, as needed) for at least 14 days before
- Any condition that required permanent discontinuation of trial treatment in the parent
- More than 20 weeks have elapsed since the subject received the last injection of
investigational medicinal product (IMP) in the parent trial (to be assessed at
- 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 within 2 weeks prior to
- Clinically significant infection within 4 weeks prior to baseline.
- A helminth parasitic infection within 6 months prior to the date when informed consent
- Tuberculosis requiring treatment within 12 months prior to screening.
- Known primary immunodeficiency disorder.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study