Phase 2
Completed N=148
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Source: ClinicalTrials.gov NCT04212169 ↗Enrolled (actual)
148
Serious AEs
3.4%
Results posted
Sep 2023
Primary outcomePrimary: Percent Change From Baseline to Week 16 in EASI Score — NA; NA; NA; NA Percentage of change from baseline — p=0.888
Summary
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 16 in EASI Score |
NA; NA; NA; NA; -51.31; -50.03 | 0.888 |
| SECONDARY Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16 |
0; 0; 1; 3 | — |
| SECONDARY Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16 |
4; 2; 1; 10 | 0.6396 |
| SECONDARY Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16 |
12; 5; 5; 16 | — |
| SECONDARY Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16 |
1; 1; 0; 5; NA; NA | 0.4450 |
| SECONDARY Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS |
9; 3; 3; 12 | — |
| SECONDARY Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS |
-1.41; -1.06; -2.01; -2.24 | — |
| SECONDARY Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS |
-1.44; -1.66; -1.52; -1.63 | — |
| SECONDARY SCORAD: Percent Change From Baseline to Week 16 |
-31.79; -29.88; -36.22; -39.42 | — |
| SECONDARY Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD |
-17.81; -11.07; -9.46; -23.13 | — |
| SECONDARY Change From Baseline to Week 16 in DLQI |
-2.9; -2.1; -2.4; -2.7 | — |
| SECONDARY Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16 |
1; 0; 1; 1; 5; 0 | — |
| SECONDARY Change From Baseline to Week 16 in POEM |
-5.4; -2.5; -3.7; -6.3 | — |
| SECONDARY Change From Baseline to Week 16 in 5-D Itch |
-3.0; -3.0; -3.8; -4.0 | — |
| SECONDARY Occurrence of Adverse Events |
37; 9; 14; 32; 7; 3 | — |
| SECONDARY Oral or Tympanic Temperature Taken During Vital Signs Assessment |
36.46; 36.43; 36.41; 36.52; 36.49; 36.71 | — |
| SECONDARY Systolic Blood Pressure Taken During Vital Signs Assessment |
117.7; 119.3; 123.8; 121.5; 117.8; 117.3 | — |
| SECONDARY Heart Rate Taken During Vital Signs Assessment |
68.1; 66.6; 71.3; 68.2; 69.4; 66.9 | — |
| SECONDARY Respiratory Rate Collected During Vital Signs Assessment |
15.4; 16.0; 16.2; 15.5; 16.0; 15.7 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology |
0; 0; 0; 0; 3; 0 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry |
0; 0; 0; 0; 21; 5 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Heart Rate (Beats/Min) Recorded on ECGs |
67.59; 65.61; 72.63; 65.18; 66.02; 63.80 | — |
| SECONDARY QT (Miliseconds) Recorded on ECGs |
385.43; 390.67; 380.04; 390.27; 387.05; 390.40 | — |
| SECONDARY Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance |
0; 0; 0; 0; 3; 2 | — |
| SECONDARY Left Ventricular Ejection Fraction Measured by Echocardiogram |
64.3; 64.7; 62.8; 63.6; 64.3; 63.0 | — |
| SECONDARY Serum MEDI3506 Concentration Profiles |
0.377; 2.158; 5.979; 0.018; 0.118; 0.188 | — |
| SECONDARY Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods |
1; 0; 0; 0; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 65 years inclusive at the time of consent.
- Body mass index between 19.0 and 40.0 kg/m2 inclusive.
- Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
- Meets at minimum 1 of the criteria, as follows:
- History of inadequate response to topical medications for AD
- Subject intolerance to treatment with topical medications for AD, or
- Topical medications are otherwise medically inadvisable
- AD that affects ≥ 10% of the body surface area (BSA).
- An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).
- An IGA score of ≥ 3.
Exclusion Criteria
- Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram [ECG]) or from safety laboratory analysis.
- Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
- Known active allergic or irritant contact dermatitis.
Data sourced from ClinicalTrials.gov (NCT04212169). 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.