An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
Who is this study for? Teenage patients over 176 lbs with Moderate to Severe Atopic Dermatitis
What treatments are being studied? Lebrikizumab
Status: Completed
Location: See all (70) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to \<18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• Male or female adolescent (≥12 years to \<18 years, and weighing ≥40 kg).
• Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
• Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
• Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
• ≥10% body surface area (BSA) of AD involvement at the baseline visit.
• History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
Locations
United States
Alabama
Pinnacle Research Group
Anniston
Arkansas
Arkansas Research Trials, LLC
North Little Rock
California
Hope Clinical Research
Canoga Park
First OC Dermatology
Fountain Valley
MD Studies
Fountain Valley
Integrative Skin Science and Research
Sacramento
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
San Diego
Southern California Dermatology, Inc.
Santa Ana
Colorado
IMMUNOe International Research Centers
Centennial
Florida
C&R Research Services USA
Coral Gables
Florida Academic Centers Research and Education, LLC
Coral Gables
Pediatric Skin Research, LLC
Coral Gables
Encore Medical Research
Hollywood
Solutions Through Advanced Research, Inc.
Jacksonville
Miami Dermatology and Laser Research
Miami
Sanchez Clinical Research Inc
Miami
Well Pharma Medical Research Corp.
Miami
Park Avenue Dermatology
Orange Park
ForCare Clinical Research
Tampa
Georgia
Georgia Pollens Clinical Research Centers, Inc
Albany
Advanced Medical Research
Sandy Springs
Georgia Skin & Cancer Clinic
Savannah
Illinois
Northwestern University
Chicago
Sneeze, Wheeze, & Itch Associates LLC
Normal
Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis
Kansas
Kansas Medical Clinic
Topeka
Kentucky
Skin Sciences, PLLC
Louisville
Louisiana
Tulane Univ School of Med
New Orleans
Maryland
Dermatology and Skin Cancer Specialists
Rockville
Michigan
Great Lakes Research Group, Inc.
Bay City
St Joseph Dermatology and Vein Clinic
Saint Joseph
Missouri
Central Dermatology PC
Saint Louis
New Hampshire
ALLCUTIS Research
Portsmouth
New York
Forest Hills Dermatology Group
Kew Gardens
Advanced Asthma and Allergy
Watertown
Ohio
Ohio Pediatric Research Association
Dayton
Oklahoma
Central States Research
Tulsa
Vital Prospects Clinical Research Institute, P.C.
Tulsa
Pennsylvania
Paddington Testing Company Inc
Philadelphia
Texas
Arlington Research Center, Inc
Arlington
Encore Imaging & Medical Research
Houston
Cutis Wellness Dermatology
Laredo
Progressive Clinical Research
San Antonio
Texas Dermatology and Laser Specialists
San Antonio
Acclaim Dermatology, PLLC
Sugar Land
Center for Clinical Studies
Webster
Virginia
PI-Coor Clinical Research, LLC
Burke
Virginia Clinical Research, Inc.
Norfolk
Other Locations
Australia
The Skin Centre
Benowa
Sinclair Dermatology
East Melbourne
Captain Stirling Medical Centre
Nedlands
Royal Childrens Hospital Melbourne
Parkville
Woden Dermatology
Phillip
The Skin Hospital
Sydney
Burswood Dermatology
Victoria Park
Veracity Clinical Research Pty Ltd
Woolloongabba
Canada
Institute for Skin Advancement
Calgary
Lynderm Research Inc.
Markham
The Centre for Clinical Trials, Inc
Oakville
CARe Clinic
Red Deer
AvantDerm
Toronto
Poland
Zespol Naukowo - Leczniczy Iwolang Sp. z o.o.
Iwonicz Zdroj
Provita Sp. z o.o
Katowice
Gabinet Dermatlogiczny. Beata Krecisz
Kielce
Diamond Clinic
Krakow
Grazyna Pulka Specjalistyczny Osrodek ALL-MED
Krakow
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Lodz
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin
Centrum Medyczne Evimed
Warszawa
CityClinic Przychodnia Lekarsko-Psychologiczna
Wroclaw
Time Frame
Start Date: 2020-02-11
Completion Date: 2022-06-22
Participants
Target number of participants: 206
Treatments
Experimental: Lebrikizumab 250 mg
Participants received two subcutaneous (SC) injections of 250 milligram(mg) Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52.
Authors
Aleksandra Lesiak, Amy Paller, Peyman Ghasri, Jill S Waibel, George Schmieder, Sidney Smith, Brent Michael Boyce, Mirel Sanchez, Craig L Leonardi, David M. Pariser, Leon H Kircik, William Rees, Scott M Dinehart, Scott Alfred Fretzin, PATRICIA LEE, Mark S Lee, Eddie Armas, Adaobi N Obasi, Jeffrey Weinberg, Armando E Acevedo, Jamie Debra Weisman, Raja Sivamani, Dareen D Siri, Vivian Laquer, Ronald Schilling, Benjamin N. Lockshin, Francisco A Kerdel, Lawrence C. Parish, Jennifer Soung, Seth Benjamin Forman, Iftikhar Hussain, Brian J Feinstein, John C. Browning, Tracy Bridges, Isaac R Melamed, Dariusz Chrostowski, Alison A Fischer, Mercedes Gonzalez-Blanco, Syed Omar Ali, Vassilios A Dimitropoulos, Jose Allongo, Erin E Boh, Stacy J Haynes, Keith Loven, Holly Kanavy, Barbara Rewerska, Lynda Jane Spelman, Dorota Krasowska, Davindra Singh, Samantha Eisman, Sheetal Sapra, Grazyna Pulka, Charles W Lynde, Dedee Murrell, Vimal Prajapati, Jacek Szepietowski, John Su
Related Therapeutic Areas
Sponsors
Collaborators: Dermira, Inc.
Leads: Eli Lilly and Company