Phase 2 Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults with Atopic Dermatitis

Phase 1

Conditions: Atopic Dermatitis
MedDRA version: 18.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2015-000595-10-HU

Lead Sponsor: MedImmune Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

- Age 18-75 years
- clinical diagnosis of atopic dermatitis
- Current disease state meeting the Hanifin and Rajka, 1980 criteria for AD
- Atopic dermatitis involvement of = 10% body surface area at Visit 1 assessed by EASI
- IGA score of = 3 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
- EASI score of = 12 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
- SCORAD of = 20 at Visit 1 (Screening)
- 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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or HIV
- Pregnant or breastfeeding women
- History of cancer
- Previous receipt of biologic agents within 4 month prior to visit 3 (week 0, day 1)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of MEDI9929 compared with placebo in adult subjects with moderate to severe AD, assessed using the change from baseline in EASI at Week 12.;Primary end point(s): Fifty percent reduction from baseline in EASI score (EASI 50) at Week 12.;Timepoint(s) of evaluation of this end point: week 12;Secondary Objective: 1. To evaluate the effect of MEDI9929 on the efficacy measure of IGA<br>2. To evaluate the effect of MEDI9929 on the efficacy measure of SCORAD<br>3. To evaluate the effect of MEDI9929 on patient-reported outcome (PRO) measures of pruritus assessed<br>using a NRS and 5-D Pruritus Scale<br>4. To evaluate the safety and tolerability of MEDI9929<br>5. To characterize the pharmacokinetics (PK) and immunogenicity of MEDI9929

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - IGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade reduction from baseline score<br>- Change from baseline in EASI<br>- 75% reduction from baseline in EASI score (EASI 75)<br>- Change from baseline in SCORAD<br>- 50% reduction from baseline in SCORAD (SCORAD 50)<br>- 75% reduction from baseline in SCORAD (SCORAD 75)<br>- Change from baseline in pruritus<br>- Safety and tolerability <br>- Pharmacokinetics and Immunogenicity <br>;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.