Atopic Dermatitis MedDRA version: 18.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: MEDI9929 / AMG 157
Product Code: MEDI9929 / AMG 157
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pending
CAS Number: 1572943-04-4
Current Sponsor code: MEDI9929/AMG15
Sponsors
MedImmune Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. To evaluate the effect of MEDI9929 on the efficacy measure of SCORAD 3. To evaluate the effect of MEDI9929 on patient-reported outcome (PRO) measures of pruritus assessed using a NRS and 5-D Pruritus Scale 4. To evaluate the safety and tolerability of MEDI9929 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 (EASI 50) at Week 12;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of subjects achieving both IGA 0 (clear) or 1 (almost clear) and a reduction from baseline of = 2 points. 2. Change from baseline in EASI 3. The proportion of subjects achieving a = 75% reduction from baseline in the EASI score (EASI 75). 4. Change from baseline in SCORAD 5. The proportion of subjects achieving a = 50% reduction from baseline in SCORAD (SCORAD 50). 6. The proportion of subjects achieving a = 75% reductionfrom baseline in SCORAD 7. The proportion of subjects achieving EASI 50 8. Change from baseline in pruritus NRS 9. Change from baseline in 5-D Pruritus score 10. Safety and tolerability of MEDI9929 including adverse events (AEs), serious adverse events (SAEs), vital signs, laboratory parameters, electrocardiograms (ECGs), and physical examinations 11. PK profile and immunogenicity of MEDI9929 ;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. | — |
Countries
Australia, Canada, Germany, Hungary, New Zealand, United States
Contacts
Public ContactClinical Trial Enquiries
MedImmune Ltd
Outcome results
None listed