Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:September 18, 2018
End Date:September 13, 2021
Contact:LEO Pharma A/S
Email:disclosure@leo-pharma.com
Phone:(+1) 877-557-1168

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An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.


Inclusion Criteria:

- Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326,
-1339, -1341, -1342, or -1346.

- 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 20 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 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.
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Cortland, New York 13045
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