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

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Tralokinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03587805

2018-000746-19 (EudraCT Number)

U1111-1282-4519 (Other Identifier)

LP0162-1337

Details and patient eligibility

About

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

Enrollment: 1,672 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,672 participants in 1 patient group

Tralokinumab, all subjects

Experimental group

Description:

Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266\*: SC injection of tralokinumab maintenance dose. \*The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.

Treatment:

Drug: Tralokinumab