Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Tralokinumab Phase 2b in Atopic Dermatitis
NCT02347176Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2015
- Primary completion
- Nov 2015
- Countries
- 6
- Sponsor
- MedImmune
- Modality
- Monoclonal Antibodies
- Drugs
- tralokinumab
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 2, randomised, double-blind trial of tralokinumab in atopic dermatitis (AD) (4 arms), sponsored by MedImmune. Primary endpoints: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at 12 weeks and Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at 12 weeks. Started Jan 2015; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo Q2W
Tralokinumab Dose 1
Tralokinumab Dose 1 Q2W
Tralokinumab Dose 2
Tralokinumab Dose 2 Q2W
Tralokinumab Dose 3
Tralokinumab Dose 3 Q2W
03
Who it enrols
Adults with moderate-to-severe atopic dermatitis diagnosed for >1 year, with BSA >= 10%, EASI >= 12, SCORAD >= 25, and IGA >= 3. Excludes patients with history of anaphylaxis to biologics, active Hepatitis B/C or HIV, cancer, or previous tralokinumab treatment.
04
Endpoints
Primary
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in EASI
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD)
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score)
05
Results
Not all primary endpoints met
Beyond the preview
Go deeper on NCT02347176.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT02347176.