Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis (D2213C00001)

MedImmune

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: Tralokinumab Dose 3; Other: Placebo; Biological: Tralokinumab Dose 2; Biological: Tralokinumab Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02347176

D2213C00001

Details and patient eligibility

About

The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis

Enrollment: 204 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physician diagnosis of atopic dermatitis for greater than (>) 1 year
• Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body surface area
• EASI score of >= 12
• SCORAD of >= 25
• IGA score of >= 3
• Effective birth control in line with protocol details

Exclusion criteria

• History of anaphylaxis following any biologic therapy
• Hepatitis B, C or human immunodeficiency virus
• Pregnant or breastfeeding
• History of cancer
• Previous receipt of tralokinumab

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.

Treatment:

Other: Placebo

Tralokinumab Dose 1

Experimental group

Description:

Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Treatment:

Biological: Tralokinumab Dose 1

Tralokinumab Dose 2

Experimental group

Description:

Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Treatment:

Biological: Tralokinumab Dose 2

Tralokinumab Dose 3

Experimental group

Description:

Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Treatment:

Biological: Tralokinumab Dose 3