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A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Placebo
TCS Cream
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening
  • Moderate to severe AD as graded by the Rajka/Langeland criteria at screening
  • History of inadequate response to a >/= 1 month (within the 3 months prior to the screening visit) treatment regimen of at least daily TCS and regular emollient for treatment of AD
  • EASI score >/= 14 at screening and end of the run-in period
  • IGA score >/= 3 (5-point scale) at screening and end of the run-in period
  • AD involvement of >/= 10% BSA at screening
  • Pruritus VAS score >/= 3 at screening

Exclusion Criteria:

  • Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
  • Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
  • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
  • Use of any complementary, alternative, or homeopathic medicines including, but not limited to, phytotherapies, traditional or non-traditional herbal medications, essential fatty acids, or acupuncture within 7 days prior to the run-in period or need for such medications during the study
  • Evidence of other skin conditions; including, but not limited to, T-cell lymphoma or allergic contact dermatitis
  • Evidence of, or ongoing treatment (including topical antibiotics) for active skin infection at screening
  • Other recent infections meeting protocol criteria
  • Active tuberculosis requiring treatment within the 12 months prior to Visit 1
  • Evidence of acute or chronic hepatitis or known liver cirrhosis
  • Known immunodeficiency, including human immunodeficiency virus (HIV) infection
  • Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the participant is willing to stop TCI use during the study (including the run-in period) and, in the investigator's opinion, it is safe to do so
  • Clinically significant abnormality on screening electrocardiogram (ECG) or laboratory tests that, in the opinion of the investigator, may pose an additional risk in administering study drug or TCS to the participant
  • Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
  • History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer

Sites / Locations

  • Dermatology Research Associate
  • UCSD Division of Dermatology
  • Univ of Calif-San Francisco
  • University of Colorado; Anschutz Cancer Pavilion
  • Ameriderm Research
  • Olympian Clinical Research
  • Northwestern University Feinberg School Of Medicine
  • University of Iowa Healthcare; Dermatology
  • Massachusetts General Hospital
  • Somerset Skin Centre
  • Washington University; Dermatology
  • Sadick Research Group
  • Oregon Health & Science University; Department of Dermatology
  • University of Texas Medical School-Houston
  • Dermatology Clinical Research Center of San Antonio
  • Virginia Clinical Research Inc.
  • St George Dermatology and Skin Cancer Centre
  • Skin & Cancer Foundation
  • Royal Melbourne Hospital; Dermatology Department
  • Fremantle Dermatology
  • Institute for Skin Advancement
  • Guildford Dermatology Specialists
  • Dr. Melinda Gooderham Medicine Professional Corporation
  • The Centre for Dermatology
  • K. Papp Clinical Research Inc.
  • XLR8 Medical Research Inc.
  • Innovaderm Research Inc.
  • Faculty Hospital; Department of Dermatology
  • Charles University School of Medicine; Deptartment of Dermatology
  • Masarykova nemocnice o.z; kozni oddeleni
  • Helsinki University Central Hospital; Skin & Allergy Hospital
  • Tampere University Hospital; Dermatology and allergology
  • Turku Central University Hospital; Dermatology and allergology
  • Hopital Saint Andre CHU De Bordeaux; Dermatologie
  • Hopital du Bocage; Dermatologie
  • Hopital Hotel Dieu Et Hme; Clinique Dermatologique
  • Hopital l Archet 2; Ginestriere, Service de; Dermatologie
  • Centre Hospitalier Lyon Sud; Dermatologie
  • Charite Mitte; Klinik fur Dermatologie
  • Universitätsklinik Bonn
  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
  • SRH Wald-Klinikum Gera GmbH; Hautkrankheiten und Allergologie
  • UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
  • Universitätsklinikum Mainz
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • ChungAng University Hospital
  • Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center
  • University Medical Center Groningen; Department of Dermatology
  • UMC Utrecht; Dermatology
  • Uniwersyteckie Centeum Kliniczne GUMed; Klinika Dermatologii, Wenerologii i Alergologii
  • DERMED Centrum Medyczne; Sp zoo
  • Laser Clinic
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
  • dermMedica sp.z o.o.
  • Clinica Universitaria de Navarra; Servicio de Dermatologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia
  • Hospital Universitario La Princesa, Servicio dermatologia
  • HUGregorio Marañón, Servicio de dermatología
  • Hospital Ramon y Cajal; servicio dermatologia
  • Hospital Universitario La Paz; Servicio de dermatologia
  • Hospital General Universitario de Valencia; servicio de dermatología
  • Inselspital Bern; Dermatologie
  • CHUV; Dermatologie
  • Universitätsspital Zürich; Dermatologische Klinik
  • Chang Gung Medical Foundation;Kaohsiung Branch; Department of Dermatology
  • National Cheng-Kung University Hospital; Department of Dermatology
  • National Taiwan University Hospital; Department of Dermatology
  • Russells Hall Hospital
  • Guys and St Thomas NHS Foundation Trust, Guys Hospital; Skin Therapy Research Unit
  • Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Churchill Hospital
  • Poole Hospital
  • Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lebrikizumab 250 mg Single Dose + TCS Cream

Lebrikizumab 125 mg Single Dose + TCS Cream

Lebrikizumab 125 mg Q4W + TCS Cream

Placebo Q4W + TCS Cream

Arm Description

Participants will receive lebrikizumab 250 milligrams (mg) SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

Participants will receive lebrikizumab 125 mg SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

Participants will receive lebrikizumab 125 mg SC every 4 weeks (Q4W) for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

Participants will receive placebo Q4W for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving a 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50) at Week 12

Secondary Outcome Measures

Percent Change From Baseline in EASI Score at Week 12
Absolute Change From Baseline in EASI Score at Week 12
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12
Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12
Absolute Change From Baseline in IGA at Week 12
Percentage of Participants Achieving an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12
Percentage of Participants with a >/=2 Point Reduction From Baseline in IGSA at Week 12
Absolute Change From Baseline in IGSA at Week 12
Percent Change From baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12
Absolute Change From baseline in SCORAD at Week 12
Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD-50/75 at Week 12
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 and 20
Percentage of Participants Achieving IGA Score of 0 or 1 at Week 12 and Maintaining IGA Score of 0 or 1 at Weeks 16
Percentage of Participants Achieving IGA Score of 0 or 1 at Week 12 and Maintaining IGA Score of 0 or 1 at Weeks 16 and 20
Percentage of Participants Achieving IGSA Score of 0 or 1 at Week 12 and Maintaining IGSA Score of 0 or 1 at Weeks 16
Percentage of Participants Achieving IGSA Score of 0 or 1 at Week 12 and Maintaining IGSA Score of 0 or 1 at Weeks 16 and 20
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 and 20
Percent Change From Baseline in Total % Body Surface Area (BSA) Affected At Week 12
Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12
Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12
Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Total Use (Grams) of TCS From Baseline to Week 12
Total Use (Grams) of TCS From Week 12 to End of Study or Early Termination
Number of Disease Flares From Baseline to Week 12
Change in AD Symptoms From Baseline to Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD)
Change in AD-Specific HealthRelated Quality of Life (QoL) From Baseline to Week 12, as Assessed by the Atopic Dermatitis Impact Questionnaire (ADIQ)
Change in Health-Related QoL From Baseline to Week 12, as Measured by the Dermatology Life Quality Index (DLQI)
Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Lebrikizumab
Percentage of Participants With ATA to Phospholipase B-Like 2 (PLBL2) Protein
Percentage of Participants With Disease Rebound
Maximum Serum Concentration (Cmax) of Lebrikizumab
Time to Reach Cmax (Tmax) of Lebrikizumab
Minimum Serum Concentration (Cmin) of Lebrikizumab
Elimination Half-Life (t1/2) of Lebrikizumab

Full Information

First Posted
January 13, 2015
Last Updated
September 28, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02340234
Brief Title
A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lebrikizumab in Patients With Persistent Moderate to Severe Atopic Dermatitis That is Inadequately Controlled by Topical Corticosteroids
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of lebrikizumab administered subcutaneously (SC) in adult participants with persistent moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a 12-week blinded treatment period, and an 8-week safety follow-up period. Following screening visit, eligible participants will enter in run-in period (Days - 14 to - 1) during which a protocol-specified topical therapy regimen will be initiated. At the end of the run-in period, participants who have: 1) demonstrated compliance with the protocol-specified TCS regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lebrikizumab 250 mg Single Dose + TCS Cream
Arm Type
Experimental
Arm Description
Participants will receive lebrikizumab 250 milligrams (mg) SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Arm Title
Lebrikizumab 125 mg Single Dose + TCS Cream
Arm Type
Experimental
Arm Description
Participants will receive lebrikizumab 125 mg SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Arm Title
Lebrikizumab 125 mg Q4W + TCS Cream
Arm Type
Experimental
Arm Description
Participants will receive lebrikizumab 125 mg SC every 4 weeks (Q4W) for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Arm Title
Placebo Q4W + TCS Cream
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo Q4W for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Intervention Type
Drug
Intervention Name(s)
Lebrikizumab
Intervention Description
Lebrikizumab will be administered SC as per the schedule specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
TCS Cream
Intervention Description
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50) at Week 12
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in EASI Score at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in EASI Score at Week 12
Time Frame
Baseline, Week 12
Title
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12
Time Frame
Week 12
Title
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12
Time Frame
Week 12
Title
Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12
Time Frame
Week 12
Title
Absolute Change From Baseline in IGA at Week 12
Time Frame
Baseline, Week 12
Title
Percentage of Participants Achieving an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12
Time Frame
Week 12
Title
Percentage of Participants with a >/=2 Point Reduction From Baseline in IGSA at Week 12
Time Frame
Week 12
Title
Absolute Change From Baseline in IGSA at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From baseline in SCORAD at Week 12
Time Frame
Baseline, Week 12
Title
Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD-50/75 at Week 12
Time Frame
Week 12
Title
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16
Time Frame
Weeks 12, 16
Title
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 and 20
Time Frame
Weeks 12, 16, 20
Title
Percentage of Participants Achieving IGA Score of 0 or 1 at Week 12 and Maintaining IGA Score of 0 or 1 at Weeks 16
Time Frame
Weeks 12, 16
Title
Percentage of Participants Achieving IGA Score of 0 or 1 at Week 12 and Maintaining IGA Score of 0 or 1 at Weeks 16 and 20
Time Frame
Weeks 12, 16, 20
Title
Percentage of Participants Achieving IGSA Score of 0 or 1 at Week 12 and Maintaining IGSA Score of 0 or 1 at Weeks 16
Time Frame
Weeks 12, 16
Title
Percentage of Participants Achieving IGSA Score of 0 or 1 at Week 12 and Maintaining IGSA Score of 0 or 1 at Weeks 16 and 20
Time Frame
Weeks 12, 16, 20
Title
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16
Time Frame
Weeks 12, 16
Title
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 and 20
Time Frame
Weeks 12, 16, 20
Title
Percent Change From Baseline in Total % Body Surface Area (BSA) Affected At Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Time Frame
Baseline, Week 12
Title
Total Use (Grams) of TCS From Baseline to Week 12
Time Frame
From Baseline to Week 12
Title
Total Use (Grams) of TCS From Week 12 to End of Study or Early Termination
Time Frame
From Week 12 to end of study or early termination (up to approximately 20 weeks)
Title
Number of Disease Flares From Baseline to Week 12
Time Frame
From Baseline to Week 12
Title
Change in AD Symptoms From Baseline to Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD)
Time Frame
Baseline, Week 12
Title
Change in AD-Specific HealthRelated Quality of Life (QoL) From Baseline to Week 12, as Assessed by the Atopic Dermatitis Impact Questionnaire (ADIQ)
Time Frame
Baseline, Week 12
Title
Change in Health-Related QoL From Baseline to Week 12, as Measured by the Dermatology Life Quality Index (DLQI)
Time Frame
Baseline, Week 12
Title
Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
Time Frame
From start of run-in period (Day -14) until study completion (up to approximately 20 Weeks)
Title
Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Lebrikizumab
Time Frame
Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141)
Title
Percentage of Participants With ATA to Phospholipase B-Like 2 (PLBL2) Protein
Time Frame
Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141)
Title
Percentage of Participants With Disease Rebound
Time Frame
From Week 12 up to approximately 20 weeks
Title
Maximum Serum Concentration (Cmax) of Lebrikizumab
Time Frame
After first dose of lebrikizumab at Week 1
Title
Time to Reach Cmax (Tmax) of Lebrikizumab
Time Frame
After first dose of lebrikizumab at Week 1
Title
Minimum Serum Concentration (Cmin) of Lebrikizumab
Time Frame
Pre-dose at Weeks 4, 8, 12
Title
Elimination Half-Life (t1/2) of Lebrikizumab
Time Frame
Pre-dose on Days 1, 8, 29, 43, 57, 85, 113, 141, study discontinuation visit (up to Day 141)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening Moderate to severe AD as graded by the Rajka/Langeland criteria at screening History of inadequate response to a >/= 1 month (within the 3 months prior to the screening visit) treatment regimen of at least daily TCS and regular emollient for treatment of AD EASI score >/= 14 at screening and end of the run-in period IGA score >/= 3 (5-point scale) at screening and end of the run-in period AD involvement of >/= 10% BSA at screening Pruritus VAS score >/= 3 at screening Exclusion Criteria: Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection Use of any complementary, alternative, or homeopathic medicines including, but not limited to, phytotherapies, traditional or non-traditional herbal medications, essential fatty acids, or acupuncture within 7 days prior to the run-in period or need for such medications during the study Evidence of other skin conditions; including, but not limited to, T-cell lymphoma or allergic contact dermatitis Evidence of, or ongoing treatment (including topical antibiotics) for active skin infection at screening Other recent infections meeting protocol criteria Active tuberculosis requiring treatment within the 12 months prior to Visit 1 Evidence of acute or chronic hepatitis or known liver cirrhosis Known immunodeficiency, including human immunodeficiency virus (HIV) infection Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the participant is willing to stop TCI use during the study (including the run-in period) and, in the investigator's opinion, it is safe to do so Clinically significant abnormality on screening electrocardiogram (ECG) or laboratory tests that, in the opinion of the investigator, may pose an additional risk in administering study drug or TCS to the participant Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Research Associate
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
UCSD Division of Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Univ of Calif-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado; Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Northwestern University Feinberg School Of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa Healthcare; Dermatology
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Washington University; Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Oregon Health & Science University; Department of Dermatology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-4501
Country
United States
Facility Name
University of Texas Medical School-Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Clinical Research Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
St George Dermatology and Skin Cancer Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Skin & Cancer Foundation
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Royal Melbourne Hospital; Dermatology Department
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Institute for Skin Advancement
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
Guildford Dermatology Specialists
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Dr. Melinda Gooderham Medicine Professional Corporation
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
K. Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
XLR8 Medical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
L2K 4L5
Country
Canada
Facility Name
Faculty Hospital; Department of Dermatology
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Charles University School of Medicine; Deptartment of Dermatology
City
Prague 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Masarykova nemocnice o.z; kozni oddeleni
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Helsinki University Central Hospital; Skin & Allergy Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Tampere University Hospital; Dermatology and allergology
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Turku Central University Hospital; Dermatology and allergology
City
Turku
ZIP/Postal Code
20250
Country
Finland
Facility Name
Hopital Saint Andre CHU De Bordeaux; Dermatologie
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital du Bocage; Dermatologie
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital l Archet 2; Ginestriere, Service de; Dermatologie
City
Nice cedex 3
ZIP/Postal Code
06200
Country
France
Facility Name
Centre Hospitalier Lyon Sud; Dermatologie
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Charite Mitte; Klinik fur Dermatologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinik Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH; Hautkrankheiten und Allergologie
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
ChungAng University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
University Medical Center Groningen; Department of Dermatology
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
Facility Name
UMC Utrecht; Dermatology
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Uniwersyteckie Centeum Kliniczne GUMed; Klinika Dermatologii, Wenerologii i Alergologii
City
Gdańsk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
DERMED Centrum Medyczne; Sp zoo
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Laser Clinic
City
Szczecin
ZIP/Postal Code
70-322
Country
Poland
Facility Name
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
dermMedica sp.z o.o.
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Clinica Universitaria de Navarra; Servicio de Dermatologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario La Princesa, Servicio dermatologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
HUGregorio Marañón, Servicio de dermatología
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal; servicio dermatologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de dermatologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital General Universitario de Valencia; servicio de dermatología
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Inselspital Bern; Dermatologie
City
Bern
ZIP/Postal Code
3000
Country
Switzerland
Facility Name
CHUV; Dermatologie
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Universitätsspital Zürich; Dermatologische Klinik
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Chang Gung Medical Foundation;Kaohsiung Branch; Department of Dermatology
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
National Cheng-Kung University Hospital; Department of Dermatology
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital; Department of Dermatology
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Russells Hall Hospital
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust, Guys Hospital; Skin Therapy Research Unit
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Poole Hospital
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis

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