Phase 2
Completed N=113
Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis
Source: ClinicalTrials.gov NCT02525094 ↗Enrolled (actual)
113
Serious AEs
4.5%
Results posted
Feb 2018
Primary outcomePrimary: Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12 — 48.2; 64.7 Percentage of participants
Summary
To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12 |
48.2; 64.7 | — |
| SECONDARY Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12 |
19.8; 24.4 | — |
| SECONDARY Mean Change From Baseline in EASI Total Score at Week 12 |
24.48; 24.05; -11.23; -12.16 | — |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline |
12.8; 19.3 | — |
| SECONDARY Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12 |
58.66; 57.68; -19.35; -24.24 | — |
| SECONDARY Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50 |
29.4; 41.0 | — |
| SECONDARY Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75 |
7.4; 9.8 | — |
| SECONDARY Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12 |
5.15; 5.26; -1.39; -1.90 | — |
| SECONDARY Mean Change From Baseline in 5-D Pruritus Score at Week 12 |
16.7; 16.0; -3.9; -3.6 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
40; 38; 3; 2 | — |
| SECONDARY Mean Trough Serum Concentration of MEDI9929 |
NA; 34.7; 50.5; 54.9 | — |
| SECONDARY Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies |
2; 1; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- AD meeting Hanifin and Rajka criteria
- Age 18-75 years inclusive at screening
- Atopic dermatitis that affects greater than/equal to 10% body surface area
- Moderate to severe AD
- Effective birth control in line with protocol details
Exclusion Criteria
- Active dermatologic conditions which may confuse the diagnosis of Atopic Dermatitis
- Hepatitis B, C or HIV
- Pregnant or breastfeeding
- History of anaphylaxis following any biologic therapy
- History of clinically significant infections within 4 weeks prior to Visit 3
- Diagnosis of helminth parasitic infection within 6 months to screening
- History of Cancer except basal cell
- Receipt of any marketed or investigational biologic agent within 4 months to visit 3
- Any clinically relevant abnormal finding
- Major surgery within 8 weeks prior to Visit 1
Data sourced from ClinicalTrials.gov (NCT02525094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.