Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

Sponsor

AstraZeneca (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04212169

Collaborator

(none)

145

Enrollment

Locations

Arms

33.4

Anticipated Duration (Months)

3.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: MEDI3506 Drug: Placebo	Phase 2

Detailed Description

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.

Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment.

Approximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.

Study Design

Study Type:

Interventional

Actual Enrollment :

145 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Investigation product only will be prepared and administered by unmasked personnel. All subjects will receive the same number of injections at each dose.

Primary Purpose:

Treatment

Official Title:

A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis

Actual Study Start Date :

Dec 9, 2019

Anticipated Primary Completion Date :

Sep 20, 2022

Anticipated Study Completion Date :

Sep 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MEDI3506 at dose level 1 Participant will receive multiple doses of MEDI3506 at dose level 1.	Drug: MEDI3506 multiple doses
Experimental: MEDI3506 at dose level 2 Participant will receive multiple doses of MEDI3506 at dose level 2.	Drug: MEDI3506 multiple doses
Experimental: MEDI3506 at dose level 3 Participant will receive multiple doses of MEDI3506 at dose level 3.	Drug: MEDI3506 multiple doses
Placebo Comparator: Placebo Participant will receive multiple doses of Placebo	Drug: Placebo multiple doses

Outcome Measures

Primary Outcome Measures

The severity of the signs of eczema and the extent affected as graded by Eczema Area and Severity Index, including change from baseline [Week 16]
To assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.

Secondary Outcome Measures

The severity of the signs of eczema and the extent affected as graded by Eczema Area and Severity Index, including change from baseline [Week 8 and Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
Disease severity assessed by examination from Investigator's Global Assessment [Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
Itch rating by patient from Peak Pruritis Numerical Rating Scale [Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
Skin pain rating by patient from Skin Pain Numerical Rating Scale [Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
Severity of signs and symptoms as graded by SCORing Atopic Dermatitis [Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
Percentage of Body Surface Area affected by AD [Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
Measurement of patient's skin problem and how it affected their life by Dermatology Life Quality Index [Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
Patient description of Atopic Dermatitis or eczema from Patient Global Impression of Severity [Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
Eczema condition declared by patient from Patient-Orientated Eczema Measure [Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.
Measurement of duration, degree, direction, disability and distribution attributed to itching from 5-D Pruritus Scale [Week 16]
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. 5-D Pruritis Scale is an accepted composite score and reporting method which looks at 5 domains (Duration, Degree, Direction, Disability and Distribution) which are then summed together to provide a total 5-D score. The 5-D score range from 5 (no pruritus) to 25 (most severe Pruritus).
Incidence and severity of Adverse events [up to 24 weeks]
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Oral or tympanic temperature taken during vital signs assessment [up to 24 weeks]
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Blood pressure taken during vital signs assessment [up to 24 weeks]
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Heart rate taken during vital signs assessment [up to 24 weeks]
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Respiratory rate collected during vital signs assessment [up to 24 weeks]
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Frequencies of abnormal laboratory assessments relative to the normal ranges for Serum chemistry [up to 24 weeks]
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Frequencies of abnormal laboratory assessments relative to the normal ranges for Haematology [up to 24 weeks]
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Frequencies of abnormal laboratory assessments relative to the normal ranges for Urinalysis [up to 24 weeks]
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Heart rate (beats/min) recorded on ECGs [up to 24 weeks]
Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
QT (ms) recorded on ECGs [up to 24 weeks]
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Presence of sinus rhythm as recorded on ECGs [up to 24 weeks]
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Frequencies of Investigator's overall ECGs evaluations, e.g. normal/abnormal and their clinical significance [up to 24 weeks]
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Left Ventricular Ejection Fraction measured by Echocardiogram [up to 24 weeks]
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Terminal half-life of MEDI3506 [Up to 24 weeks]
Collectively with maximum concentration of MEDI3506 are used to evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
Maximum concentration of MEDI3506 [Up to 24 weeks]
Collectively with terminal half-life are used to evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
Incidence of Anti-drug antibody [Up to 24 weeks]
To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Birmingham	Alabama	United States	35209
2	Research Site	Santa Monica	California	United States	90404
3	Research Site	Jacksonville	Florida	United States	32256
4	Research Site	Miami	Florida	United States	33180
5	Research Site	Orlando	Florida	United States	32806
6	Research Site	Baton Rouge	Louisiana	United States	70808
7	Research Site	Charlotte	North Carolina	United States	28277
8	Research Site	Tulsa	Oklahoma	United States	74136
9	Research Site	Providence	Rhode Island	United States	02903
10	Research Site	Spartanburg	South Carolina	United States	29303
11	Research Site	Memphis	Tennessee	United States	38119
12	Research Site	San Antonio	Texas	United States	78213
13	Research Site	San Antonio	Texas	United States	78229
14	Research Site	Box Hill		Australia	3128
15	Research Site	Carlton		Australia	3053
16	Research Site	East Melbourne		Australia	3002
17	Research Site	Fremantle		Australia	6160
18	Research Site	Woolloongabba		Australia	04102
19	Research Site	Berlin		Germany	10117
20	Research Site	Dresden		Germany	01307
21	Research Site	Frankfurt/Main		Germany	60590
22	Research Site	Hamburg		Germany	20246
23	Research Site	Kiel		Germany	24105
24	Research Site	Mahlow		Germany	15831
25	Research Site	Bialystok		Poland	15-453
26	Research Site	Kielce		Poland	25-355
27	Research Site	Krakow		Poland	30-363
28	Research Site	Poznan		Poland	60-681
29	Research Site	Skierniewice		Poland	96-100
30	Research Site	Wroclaw		Poland	50-566
31	Research Site	Łódź		Poland	90-436
32	Research Site	Alcobendas		Spain	28100
33	Research Site	Leganés		Spain	28915
34	Research Site	Sevilla		Spain	41003
35	Research Site	Corby		United Kingdom	NN18 9EZ
36	Research Site	High Wycombe		United Kingdom	HP11 2QW
37	Research Site	Kenilworth		United Kingdom	CV8 1JD
38	Research Site	Northwood		United Kingdom	HA6 2RN
39	Research Site	Romford		United Kingdom	RM1 3PJ
40	Research Site	Shipley		United Kingdom	BD18 3SA
41	Research Site	Sidcup		United Kingdom	DA14 6LT
42	Research Site	Wokingham		United Kingdom	RG40 1XS