Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults with Atopic Dermatitis

A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects with Moderate-to-Severe Atopic Dermatitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003725-17-DE

Enrollment

184

Registered

2015-01-05

Start date

2015-04-15

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis MedDRA version: 19.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858

Interventions

Product Name: Tralokinumab Product Code: CAT-354 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tralokinumab CAS Number: 1044515-88-9 Other descriptive name: CAT-354 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 18-75 years - Physician diagnosis of atopic dermatitis for > 1 year - Atopic dermatitis involvement of = 15% body surface area - EASI score of = 12 - SCORAD of = 25 - IGA score of = 3 - Effective birth control in line with protocol details Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: - History of anaphylaxis following any biologic therapy - Hepatitis B, C or HIV - Pregnant or breastfeeding - History of cancer - Previous receipt of tralokinumab

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of tralokinumab in adults with atopic dermatitis using change from baseline in Eczema Area and Severity Index (EASI) ;Secondary Objective: - To evaluate the efficacy of tralokinumab using efficacy measures of Scoring of Atopic Dermatitis (SCORAD) and Investigator's Global Assessment (IGA) in adults with atopic dermatitis - To evaluate the safety and tolerability of tralokinumab in adults with atopic dermatitis - To evaluate the effect of tralokinumab on quality of life in adults with atopic dermatitis - To characterize the pharmacokinetics (PK) and immunogenicity of tralokinumab in adults with atopic dermatitis;Primary end point(s): Change from baseline in EASI at Week 12;Timepoint(s) of evaluation of this end point: Bi-weekly throughout study.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of tralokinumab in adults with atopic dermatitis using change from baseline in Eczema Area and Severity Index (EASI) ;Secondary Objective: - To evaluate the efficacy of tralokinumab using efficacy measures of Scoring of Atopic Dermatitis (SCORAD) and Investigator's Global Assessment (IGA) in adults with atopic dermatitis - To evaluate the safety and tolerability of tralokinumab in adults with atopic dermatitis - To evaluate the effect of tralokinumab on quality of life in adults with atopic dermatitis - To characterize the pharmacokinetics (PK) and immunogenicity of tralokinumab in adults with atopic dermatitis;Primary end point(s): Change from baseline in EASI at Week 12;Timepoint(s) of evaluation of this end point: Bi-weekly throughout study.

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Secondary

Measure	Time frame
Secondary end point(s): - Change from baseline in EASI - Safety and tolerability - Percentage of subjects achieving IGA of 0 (clear) or 1 (almost clear) - Change from baseline in SCORAD - Percentage of subjects achieving 50% reduction from baseline in EASI - Percentage of subjects achieving 50% reduction from baseline in SCORAD - Change from baseline in pruritus - Change from baseline in quality of life - Pharmacokinetics of tralokinumab - Immunogenicity of tralokinumab;Timepoint(s) of evaluation of this end point: Secondary endpoints will be measured up to Week 12 for on-therapy effects and time points beyond end of treatment for off-therapy effects.	—

Measure

Time frame

Secondary end point(s): - Change from baseline in EASI - Safety and tolerability - Percentage of subjects achieving IGA of 0 (clear) or 1 (almost clear) - Change from baseline in SCORAD - Percentage of subjects achieving 50% reduction from baseline in EASI - Percentage of subjects achieving 50% reduction from baseline in SCORAD - Change from baseline in pruritus - Change from baseline in quality of life - Pharmacokinetics of tralokinumab - Immunogenicity of tralokinumab;Timepoint(s) of evaluation of this end point: Secondary endpoints will be measured up to Week 12 for on-therapy effects and time points beyond end of treatment for off-therapy effects.

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Countries

Australia, Canada, Germany, Japan, Poland, United States

Contacts

Public ContactMedImmune Contact

MedImmune

ClinicalTrialEnquiries@Medimmune.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026