A Study of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis



Status:Active, not recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:January 30, 2018
End Date:May 2019

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A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared
with placebo in patients with moderate-to-severe atopic dermatitis.


Inclusion Criteria:

- Male or female, 18 years or older.

- Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year
before the screening visit .

- Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline
visit.

- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and
the baseline visit.

- ≥10% body surface area (BSA) of AD involvement at the screening and the baseline
visit.

Exclusion Criteria:

- Treatment with any of the following agents within 4 weeks prior to the baseline visit:

- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine,
methotrexate, etc.)

- Phototherapy and photochemotherapy (PUVA) for AD.

- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)
within 1 week prior to the baseline visit.

- Treatment with:

- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is
longer, prior to the baseline visit.

- Dupilumab within 3 months prior to baseline visit.

- Cell-depleting biologics, including rituximab, within 6 months prior to the baseline
visit.

- Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit
(whichever is longer).

- Use of prescription moisturizers within 7 days of the baseline visit.
We found this trial at
58
sites
2919 West Swann Avenue
Largo, Florida 33770
Principal Investigator: Matthew Zook, MD
Phone: 727-935-0508
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: David Rosmarin, MD
Phone: 617-636-7462
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: April Armstrong, MD
Phone: 323-865-3641
University of Southern California The University of Southern California is one of the world’s leading...
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911 Park Avenue
New York, New York 10075
212-710-9855
Principal Investigator: Neil Sadick, MD
Phone: 212-772-7242
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
Principal Investigator: Mark Lee, MD
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Albuquerque, New Mexico 87106
Principal Investigator: Eduardo Tschen, MD
Phone: 505-247-4220
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Arlington, Texas 76011
Principal Investigator: Angela Moore, MD
Phone: 817-795-7546
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Austin, Texas 78746
Principal Investigator: Daniel Friedmann, MD
Phone: 512-615-3193
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Baton Rouge, Louisiana 70808
Principal Investigator: Tom Meek Jr, MD
Phone: 225-768-2850
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Bellaire, Texas 77401
Principal Investigator: Craig Teller, MD
Phone: 832-553-2339
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Beverly, Massachusetts 01915
Principal Investigator: David Greenstein, MD
Phone: 978-969-6897
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Boynton Beach, Florida 33437
Principal Investigator: Joshua Berlin, MD
Phone: 561-739-5252
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3413 Lacrosse
Bryant, Arkansas 72022
Principal Investigator: Dowling Stough, MD
Phone: 501-655-6138
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Charleston, South Carolina 29414
Principal Investigator: Todd Schlesinger, MD
Phone: 843-556-8886
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5815 Blakeney Park Drive
Charlotte, North Carolina 28277
Principal Investigator: Patrick McElgunn, MD
Phone: 704-527-6672
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Cleveland, Ohio 44012
Principal Investigator: Neil Korman, MD
Phone: 216-844-8200
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Coral Gables, Florida 33134
Principal Investigator: Francisco Kerdel, MD
Phone: 305-624-2110
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Dallas, Texas 75246
Principal Investigator: Alan Menter, MD
Phone: 972-354-7989
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Fremont, California 94538
Principal Investigator: Sunil Dhawan, MD
Phone: 510-797-0140
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Goodlettsville, Tennessee 37072
Principal Investigator: Keith Loven, MD
Phone: 615-859-7546
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7000 Fannin Street
Houston, Texas 77030
Principal Investigator: Adelaide Hebert, MD
Phone: 713-500-8266
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Indianapolis, Indiana 46256
Principal Investigator: Scott Fretzin, MD
Phone: 317-516-5030
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Johnston, Rhode Island 02919
Principal Investigator: Ellen Frankel, MD
Phone: 401-454-3800
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Las Vegas, Nevada 89148
Principal Investigator: James Del Rosso, DO
Phone: 702-331-4123
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Los Angeles, California 90045
Principal Investigator: Howard Sofen, MD
Phone: 310-337-7171
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485 East Gray Street
Louisville, Kentucky 40217
Principal Investigator: Leon Kircik, MD
Phone: 502-451-9000
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Marietta, Georgia 30060
Principal Investigator: Mark Knautz, MD
Phone: 770-422-1013
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Murfreesboro, Tennessee 37130
Principal Investigator: Christina Feser, DO
Phone: 615-410-3460
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Nashville, Tennessee 37215
Principal Investigator: Michael Gold, MD
Phone: 615-383-9668
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New York, New York 10022
Principal Investigator: Jeremy Fenton, MD
Phone: 646-604-4344
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New York, New York 10029
Principal Investigator: Emma Guttman, MD
Phone: 212-241-3288
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Norfolk, Virginia 23507
Principal Investigator: David Pariser, MD
Phone: 757-625-0151
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North Miami Beach, Florida 33162
Principal Investigator: Tory Sullivan, MD
Phone: 305-652-8600
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Principal Investigator: Raymond Cornelison, Jr., MD
Phone: 405-602-3939
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Overland Park, Kansas 66215
Principal Investigator: Mark McCune, MD
Phone: 913-541-3230
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Plainfield, Indiana 46168
Principal Investigator: Scott Guenthner, MD
Phone: 317-837-6082
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Portland, Oregon 97223
Principal Investigator: Andrew Blauvelt, MD
Phone: 503-245-1525
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Portsmouth, New Hampshire 03801
Principal Investigator: Abel Jarell, MD
Phone: 603-319-8863
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Principal Investigator: Adnan Nasir, MD
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Redwood City, California 94063
Principal Investigator: Justin Ko, MD
Phone: 650-498-4880
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Rockville, Maryland 20850
Principal Investigator: Benjamin Lockshin, MD
Phone: 301-355-3183
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Rogers, Arkansas 72758
Principal Investigator: Cheryl Hull, MD
Phone: 479-876-8205
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Sacramento, California 95819
Principal Investigator: Emil Tangetti, MD
Phone: 916-454-5922
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San Diego, California 92123
Principal Investigator: Neal Bhatia, MD
Phone: 858-571-6800
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San Diego, California
Principal Investigator: Tissa Hata, MD
Phone: 858-657-8322
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Sandy Springs, Georgia 30328
Principal Investigator: Jamie Weisman, MD
Phone: 404-939-9220
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Sanford, Florida 32771
Principal Investigator: Rion Forconi, MD
Phone: 407-878-5830
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Santa Monica, California 90404
Principal Investigator: Paul Steven Yamauchi, MD
Phone: 310-828-8887
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Scottsdale, Arizona 85255
Principal Investigator: Brenda LaTowsky, MD
Phone: 480-398-1550
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Seattle, Washington 98101
Principal Investigator: Peter Jenkin, MD
Phone: 206-267-2100
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Spokane, Washington 99204
Principal Investigator: William Werschler, MD
Phone: 509-343-3710
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Stony Brook, New York 11790
Principal Investigator: Elyse Rafal, MD
Phone: 631-689-1900
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Troy, Michigan 48084
Principal Investigator: George Murakawa, MD
Phone: 248-244-8448
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Washington, District of Columbia 20037
Principal Investigator: Alison Ehrlich, MD
Phone: 202-741-3547
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Webster, Texas 77598
Principal Investigator: Stephen Tyring, MD
Phone: 281-333-2288
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West Dundee, Illinois 60118
Principal Investigator: Paul Getz, MD
Phone: 847-851-8888
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603 Village Boulevard
West Palm Beach, Florida 33406
Principal Investigator: Barry Kuttner, MD
Phone: 561-964-6664
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Wilmington, North Carolina 28403
Principal Investigator: Rosalyn George, MD
Phone: 910-256-4350
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