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kzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults with Atopic Dermatitis - D2213C00001
Study identifier:D2213C00001
ClinicalTrials.gov identifier:NCT02347176
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects with Moderate-to-Severe Atopic Dermatitis
Medical condition
Atopic Dermatitis
Phase
Phase 2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
204
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 23 Jan 2015
Primary Completion Date: 27 Nov 2015
Study Completion Date: 05 Feb 2016
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2018 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Worcester, MA, United States, 01605
Location
Research Site
Miami, FL, United States, 33144
Location
Research Site
Houston, TX, United States, 77004
Location
Research Site
Charleston, SC, United States, 29414
Location
Research Site
Pflugerville, TX, United States, 78660
Location
Research Site
Fremont, CA, United States, 94538
Location
Research Site
Houston, TX, United States, 77056
Location
Research Site
San Antonio, TX, United States, 78229
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. | Other: Placebo Subcutaneous injection with placebo |
| Experimental: Tralokinumab Dose 1 Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. | Biological/Vaccine: Tralokinumab Dose 1 Subcutaneous injection with tralokinumab |
| Experimental: Tralokinumab Dose 2 Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. | Biological/Vaccine: Tralokinumab Dose 2 Subcutaneous injection with tralokinumab |
| Experimental: Tralokinumab Dose 3 Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. | Biological/Vaccine: Tralokinumab Dose 3 Subcutaneous injection with tralokinumab |
Contacts
Contact
AstraZeneca Clinical Study Information Center
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hOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
