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

Phase 1

Conditions: Atopic Dermatitis
MedDRA version: 18.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2015-000595-10-DE

Lead Sponsor: MedImmune Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Written informed consent and any locally required authorization (eg, Health Insurance
Portability and Accountability Act [HIPAA] in the USA, European Union [EU] Data
Privacy Directive in the EU) obtained from the subject prior to performing any protocolrelated
procedures, including screening evaluations.
2. Age 18-75 years inclusive at the time of Screening
3. Current disease state meeting the Hanifin and Rajka, 1980 criteria for AD (see Appendix 5)
4. Atopic dermatitis that affects = 10% body surface area at Visit 1 (Screening), as assessed
by EASI
5. A IGA score of = 3 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
6. An EASI score of = 12 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
7. A SCORAD of = 20 at Visit 1 (Screening)
8. No clinically significant abnormality on the basis of medical/medication history or
physical examination
9. If on allergen-specific immunotherapy, subjects must be on a maintenance dose and
schedule for = 1 month prior to Visit 1 (Screening). Allergen-specific immunotherapy
refers to subcutaneous immunotherapy to aeroallergens and/or venom (Hymenoptera) as
well as sublingual immunotherapy to aeroallergens.
10. Able and willing to comply with the requirements of the protocol
11. Females of childbearing potential who are sexually active with a nonsterilized male
partner must use highly effective contraception from enrollment (after written informed
consent is obtained) and must agree to continue using such precautions through to the end
of the study; cessation of birth control after this point should be discussed with a
responsible physician. Periodic abstinence, the rhythm method, and the withdrawal
method are not acceptable methods of birth control. Females of childbearing potential are
defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral
oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). A highly effective method of
contraception is defined as one that results in a low failure rate (ie, less than 1% per year)
when used consistently and correctly (Table 4.1.2-1).

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

1. Active dermatologic conditions, which may confound the diagnosis of AD or would
interfere with assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous
lymphoma, ichthyosis, or psoriasis
2. Known active allergic or irritant contact dermatitis
3. History of a clinically significant infection within 4 weeks prior to Visit 3 (Week 0,
Day 1) which, in the opinion of the investigator or medical monitor, may compromise the
safety of the subject in the study, interfere with evaluation of the investigational product,
or reduce the subject’s ability to participate in the study. Clinically significant infections
are defined as:
? A systemic infection or
? A serious skin infection requiring parenteral antibiotics, antiviral, or antifungal
medication.
4. Diagnosis of a helminth parasitic infection within 6 months prior to screening that has not
been treated with, or has failed to respond to standard of care therapy
5. History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix
treated with apparent success with curative therapy = 12 months prior to screening or other malignancies treated with apparent success with curative therapy = 5 years prior to
Visit 1 (Screening)
6. History of chronic alcohol or drug abuse within 12 months prior to screening, or any
condition associated with poor compliance as judged by the investigator
7. Pregnant or breastfeeding women or pregnancy planned within the next 6 months from
last dose
8. Use of tanning beds or phototherapy within 8 weeks of Visit 3 (Week 0, Day 1)
9. Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives
prior to Visit 3 (Week 0, Day 1), whichever is longer
10. Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to
Visit 3 (Week 0, Day 1), whichever is longer
11. Treatment with the following medications within the last 4 weeks prior to Visit 3
(Week 0, Day 1):
a. Systemic immunosuppressive/immunomodulating drugs (eg, methotrexate,
cyclosporine, azathioprine, mycophenolate mofetil, tacrolimus, interferon ?)
b. Immunoglobulin and/or blood products
c. Systemic corticosteroids (topical, inhaled, or intranasal delivery are permitted)
d. Topical calcineurin inhibitor use
12. Subjects who have received a live or attenuated vaccine within 4 weeks prior to Visit 3
(Week 0, Day 1). Receipt of inactive/killed vaccinations (eg, inactive influenza) is
allowed provided they are not administered within 1 week before/after any study visit.
13. Receipt of the Th2 cytokine inhibitor suplatast within 15 days prior to Visit 1 (Screening)
is allowed
14. Known history of allergy or reaction to any component of the investigational product
formulation
15. History of anaphylaxis following any biologic therapy
16. Subjects who are intolerant or contraindicated to use study-mandated TCS for lesional
skin
17. Any clinically relevant abnormal findings in physical examination ECG, vital signs,
hematology, clinical chemistry, or urinalysis during screening, which in the opinion of
the investigator or medical monitor may compromise the safety of the subject in the study
or interfere with evaluation of the investigational product or reduce the subject’s ability
to participate in the study
18. Evidence of active liver disease, including jaundice or aspartate transaminase (AST),
alanine transaminase (ALT), or alkaline phosphatase greater than twice the upper limit o

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.;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;Primary end point(s): The proportion of subjects achieving a = 50% reduction from baseline in the EASI score<br>(EASI 50) at Week 12;Timepoint(s) of evaluation of this end point: week 12

Secondary Outcome Measures

Name	Time	Method

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