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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02340234




Registration number
NCT02340234
Ethics application status
Date submitted
13/01/2015
Date registered
16/01/2015
Date last updated
2/10/2017

Titles & IDs
Public title
A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
2014-000049-56
Secondary ID [2] 0 0
GS29250
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lebrikizumab
Treatment: Drugs - Placebo
Treatment: Drugs - TCS Cream

Experimental: Lebrikizumab 250 mg Single Dose + TCS Cream - 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.

Experimental: Lebrikizumab 125 mg Single Dose + TCS Cream - 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.

Experimental: Lebrikizumab 125 mg Q4W + TCS Cream - 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.

Placebo comparator: Placebo Q4W + TCS Cream - 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.


Treatment: Drugs: Lebrikizumab
Lebrikizumab will be administered SC as per the schedule specified in the respective arms.

Treatment: Drugs: Placebo
Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.

Treatment: Drugs: TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving a 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percent Change From Baseline in EASI Score at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Absolute Change From Baseline in EASI Score at Week 12
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Absolute Change From Baseline in IGA at Week 12
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Percentage of Participants Achieving an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Percentage of Participants with a >/=2 Point Reduction From Baseline in IGSA at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Absolute Change From Baseline in IGSA at Week 12
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Percent Change From baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12
Timepoint [10] 0 0
Baseline, Week 12
Secondary outcome [11] 0 0
Absolute Change From baseline in SCORAD at Week 12
Timepoint [11] 0 0
Baseline, Week 12
Secondary outcome [12] 0 0
Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD-50/75 at Week 12
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16
Timepoint [13] 0 0
Weeks 12, 16
Secondary outcome [14] 0 0
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 and 20
Timepoint [14] 0 0
Weeks 12, 16, 20
Secondary outcome [15] 0 0
Percentage of Participants Achieving IGA Score of 0 or 1 at Week 12 and Maintaining IGA Score of 0 or 1 at Weeks 16
Timepoint [15] 0 0
Weeks 12, 16
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Weeks 12, 16, 20
Secondary outcome [17] 0 0
Percentage of Participants Achieving IGSA Score of 0 or 1 at Week 12 and Maintaining IGSA Score of 0 or 1 at Weeks 16
Timepoint [17] 0 0
Weeks 12, 16
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Weeks 12, 16, 20
Secondary outcome [19] 0 0
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16
Timepoint [19] 0 0
Weeks 12, 16
Secondary outcome [20] 0 0
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 and 20
Timepoint [20] 0 0
Weeks 12, 16, 20
Secondary outcome [21] 0 0
Percent Change From Baseline in Total % Body Surface Area (BSA) Affected At Week 12
Timepoint [21] 0 0
Baseline, Week 12
Secondary outcome [22] 0 0
Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12
Timepoint [22] 0 0
Baseline, Week 12
Secondary outcome [23] 0 0
Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12
Timepoint [23] 0 0
Baseline, Week 12
Secondary outcome [24] 0 0
Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Timepoint [24] 0 0
Baseline, Week 12
Secondary outcome [25] 0 0
Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Timepoint [25] 0 0
Baseline, Week 12
Secondary outcome [26] 0 0
Total Use (Grams) of TCS From Baseline to Week 12
Timepoint [26] 0 0
From Baseline to Week 12
Secondary outcome [27] 0 0
Total Use (Grams) of TCS From Week 12 to End of Study or Early Termination
Timepoint [27] 0 0
From Week 12 to end of study or early termination (up to approximately 20 weeks)
Secondary outcome [28] 0 0
Number of Disease Flares From Baseline to Week 12
Timepoint [28] 0 0
From Baseline to Week 12
Secondary outcome [29] 0 0
Change in AD Symptoms From Baseline to Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD)
Timepoint [29] 0 0
Baseline, Week 12
Secondary outcome [30] 0 0
Change in AD-Specific HealthRelated Quality of Life (QoL) From Baseline to Week 12, as Assessed by the Atopic Dermatitis Impact Questionnaire (ADIQ)
Timepoint [30] 0 0
Baseline, Week 12
Secondary outcome [31] 0 0
Change in Health-Related QoL From Baseline to Week 12, as Measured by the Dermatology Life Quality Index (DLQI)
Timepoint [31] 0 0
Baseline, Week 12
Secondary outcome [32] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
Timepoint [32] 0 0
From start of run-in period (Day -14) until study completion (up to approximately 20 Weeks)
Secondary outcome [33] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Lebrikizumab
Timepoint [33] 0 0
Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141)
Secondary outcome [34] 0 0
Percentage of Participants With ATA to Phospholipase B-Like 2 (PLBL2) Protein
Timepoint [34] 0 0
Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141)
Secondary outcome [35] 0 0
Percentage of Participants With Disease Rebound
Timepoint [35] 0 0
From Week 12 up to approximately 20 weeks
Secondary outcome [36] 0 0
Maximum Serum Concentration (Cmax) of Lebrikizumab
Timepoint [36] 0 0
After first dose of lebrikizumab at Week 1
Secondary outcome [37] 0 0
Time to Reach Cmax (Tmax) of Lebrikizumab
Timepoint [37] 0 0
After first dose of lebrikizumab at Week 1
Secondary outcome [38] 0 0
Minimum Serum Concentration (Cmin) of Lebrikizumab
Timepoint [38] 0 0
Pre-dose at Weeks 4, 8, 12
Secondary outcome [39] 0 0
Elimination Half-Life (t1/2) of Lebrikizumab
Timepoint [39] 0 0
Pre-dose on Days 1, 8, 29, 43, 57, 85, 113, 141, study discontinuation visit (up to Day 141)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
212
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [2] 0 0
Skin & Cancer Foundation - Carlton
Recruitment hospital [3] 0 0
Royal Melbourne Hospital; Dermatology Department - Parkville
Recruitment hospital [4] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Czechia
State/province [17] 0 0
Plzen
Country [18] 0 0
Czechia
State/province [18] 0 0
Prague 10
Country [19] 0 0
Czechia
State/province [19] 0 0
Usti nad Labem
Country [20] 0 0
Finland
State/province [20] 0 0
Helsinki
Country [21] 0 0
Finland
State/province [21] 0 0
Tampere
Country [22] 0 0
Finland
State/province [22] 0 0
Turku
Country [23] 0 0
France
State/province [23] 0 0
Bordeaux
Country [24] 0 0
France
State/province [24] 0 0
Dijon
Country [25] 0 0
France
State/province [25] 0 0
Nantes
Country [26] 0 0
France
State/province [26] 0 0
Nice cedex 3
Country [27] 0 0
France
State/province [27] 0 0
Pierre Benite
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Bonn
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt
Country [31] 0 0
Germany
State/province [31] 0 0
Gera
Country [32] 0 0
Germany
State/province [32] 0 0
Kiel
Country [33] 0 0
Germany
State/province [33] 0 0
Mainz
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Netherlands
State/province [35] 0 0
Amsterdam
Country [36] 0 0
Netherlands
State/province [36] 0 0
Groningen
Country [37] 0 0
Netherlands
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Utrecht
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Poland
State/province [38] 0 0
Gdansk
Country [39] 0 0
Poland
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Lodz
Country [40] 0 0
Poland
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Szczecin
Country [41] 0 0
Poland
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Tarnow
Country [42] 0 0
Poland
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Wroclaw
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Spain
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Navarra
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
Country [47] 0 0
Switzerland
State/province [47] 0 0
Bern
Country [48] 0 0
Switzerland
State/province [48] 0 0
Lausanne
Country [49] 0 0
Switzerland
State/province [49] 0 0
Zürich
Country [50] 0 0
Taiwan
State/province [50] 0 0
Kaohsiung
Country [51] 0 0
Taiwan
State/province [51] 0 0
Tainan
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taipei
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Dudley
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London
Country [55] 0 0
United Kingdom
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Newcastle upon Tyne
Country [56] 0 0
United Kingdom
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Oxford
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Poole
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02340234
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02340234