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.

Lead Sponsor:

LEO Pharma

Stanford Investigator(s):

Intervention(s):

  • Drug: Tralokinumab

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - 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
   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.

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elidia Tafoya
650-724-1982
Recruiting