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Trial record 21 of 157 for:    Dermatitis, Atopic, 8

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02340234
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Lebrikizumab Drug: Placebo Drug: TCS Cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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.
Drug: Lebrikizumab
Lebrikizumab will be administered SC as per the schedule specified in the respective arms.

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

Drug: TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily

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

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

Drug: TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily

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

Drug: TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily

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

Drug: TCS Cream
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily




Primary Outcome Measures :
  1. 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 Measures :
  1. Percent Change From Baseline in EASI Score at Week 12 [ Time Frame: Baseline, Week 12 ]
  2. Absolute Change From Baseline in EASI Score at Week 12 [ Time Frame: Baseline, Week 12 ]
  3. Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12 [ Time Frame: Week 12 ]
  4. Percentage of Participants Achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
  5. Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12 [ Time Frame: Week 12 ]
  6. Absolute Change From Baseline in IGA at Week 12 [ Time Frame: Baseline, Week 12 ]
  7. Percentage of Participants Achieving an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
  8. Percentage of Participants with a >/=2 Point Reduction From Baseline in IGSA at Week 12 [ Time Frame: Week 12 ]
  9. Absolute Change From Baseline in IGSA at Week 12 [ Time Frame: Baseline, Week 12 ]
  10. Percent Change From baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12 [ Time Frame: Baseline, Week 12 ]
  11. Absolute Change From baseline in SCORAD at Week 12 [ Time Frame: Baseline, Week 12 ]
  12. Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD-50/75 at Week 12 [ Time Frame: Week 12 ]
  13. Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 [ Time Frame: Weeks 12, 16 ]
  14. Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 and 20 [ Time Frame: Weeks 12, 16, 20 ]
  15. 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 ]
  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 [ Time Frame: Weeks 12, 16, 20 ]
  17. 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 ]
  18. 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 ]
  19. Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 [ Time Frame: Weeks 12, 16 ]
  20. Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 and 20 [ Time Frame: Weeks 12, 16, 20 ]
  21. Percent Change From Baseline in Total % Body Surface Area (BSA) Affected At Week 12 [ Time Frame: Baseline, Week 12 ]
  22. Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]
  23. Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12 [ Time Frame: Baseline, Week 12 ]
  24. Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12 [ Time Frame: Baseline, Week 12 ]
  25. Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12 [ Time Frame: Baseline, Week 12 ]
  26. Total Use (Grams) of TCS From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ]
  27. 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) ]
  28. Number of Disease Flares From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ]
  29. Change in AD Symptoms From Baseline to Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD) [ Time Frame: Baseline, Week 12 ]
  30. 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 ]
  31. Change in Health-Related QoL From Baseline to Week 12, as Measured by the Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Week 12 ]
  32. 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) ]
  33. 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) ]
  34. 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) ]
  35. Percentage of Participants With Disease Rebound [ Time Frame: From Week 12 up to approximately 20 weeks ]
  36. Maximum Serum Concentration (Cmax) of Lebrikizumab [ Time Frame: After first dose of lebrikizumab at Week 1 ]
  37. Time to Reach Cmax (Tmax) of Lebrikizumab [ Time Frame: After first dose of lebrikizumab at Week 1 ]
  38. Minimum Serum Concentration (Cmin) of Lebrikizumab [ Time Frame: Pre-dose at Weeks 4, 8, 12 ]
  39. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340234


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Locations
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United States, California
Dermatology Research Associate
Los Angeles, California, United States, 90045
UCSD Division of Dermatology
San Diego, California, United States, 92122
Univ of Calif-San Francisco
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado; Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Florida
Ameriderm Research
Ormond Beach, Florida, United States, 32174
Olympian Clinical Research
Tampa, Florida, United States, 33609
United States, Illinois
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Healthcare; Dermatology
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Somerset Skin Centre
Troy, Michigan, United States, 48084
United States, Missouri
Washington University; Dermatology
Saint Louis, Missouri, United States, 63110
United States, New York
Sadick Research Group
New York, New York, United States, 10075
United States, Oregon
Oregon Health & Science University; Department of Dermatology
Portland, Oregon, United States, 97239-4501
United States, Texas
University of Texas Medical School-Houston
Houston, Texas, United States, 77030
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Clinical Research Inc.
Norfolk, Virginia, United States, 23502
Australia, New South Wales
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia, 2217
Australia, Victoria
Skin & Cancer Foundation
Carlton, Victoria, Australia, 3053
Royal Melbourne Hospital; Dermatology Department
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia, 6160
Canada, Alberta
Institute for Skin Advancement
Calgary, Alberta, Canada, T3A 2N1
Canada, British Columbia
Guildford Dermatology Specialists
Surrey, British Columbia, Canada, V3R 6A7
Canada, Ontario
Dr. Melinda Gooderham Medicine Professional Corporation
Peterborough, Ontario, Canada, K9J 5K2
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada, N2J 1C4
XLR8 Medical Research Inc.
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, L2K 4L5
Czechia
Faculty Hospital; Department of Dermatology
Plzen, Czechia, 305 99
Charles University School of Medicine; Deptartment of Dermatology
Prague 10, Czechia, 100 34
Masarykova nemocnice o.z; kozni oddeleni
Usti nad Labem, Czechia, 401 13
Finland
Helsinki University Central Hospital; Skin & Allergy Hospital
Helsinki, Finland, 00029
Tampere University Hospital; Dermatology and allergology
Tampere, Finland, 33520
Turku Central University Hospital; Dermatology and allergology
Turku, Finland, 20250
France
Hopital Saint Andre CHU De Bordeaux; Dermatologie
Bordeaux, France, 33075
Hopital du Bocage; Dermatologie
Dijon, France, 21079
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
Nantes, France, 44093
Hopital l Archet 2; Ginestriere, Service de; Dermatologie
Nice cedex 3, France, 06200
Centre Hospitalier Lyon Sud; Dermatologie
Pierre Benite, France, 69495
Germany
Charite Mitte; Klinik fur Dermatologie
Berlin, Germany, 10117
Universitätsklinik Bonn
Bonn, Germany, 53127
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt, Germany, 60590
SRH Wald-Klinikum Gera GmbH; Hautkrankheiten und Allergologie
Gera, Germany, 07548
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
Kiel, Germany, 24105
Universitätsklinikum Mainz
Mainz, Germany, 55131
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
ChungAng University Hospital
Seoul, Korea, Republic of, 06973
Netherlands
Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center
Amsterdam, Netherlands, 1100 DD
University Medical Center Groningen; Department of Dermatology
Groningen, Netherlands, 9700RB
UMC Utrecht; Dermatology
Utrecht, Netherlands, 3584 CX
Poland
Uniwersyteckie Centeum Kliniczne GUMed; Klinika Dermatologii, Wenerologii i Alergologii
Gdańsk, Poland, 80-402
DERMED Centrum Medyczne; Sp zoo
Lodz, Poland, 90-265
Laser Clinic
Szczecin, Poland, 70-322
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
Tarnow, Poland, 33-100
dermMedica sp.z o.o.
Wroclaw, Poland, 51-318
Spain
Clinica Universitaria de Navarra; Servicio de Dermatologia
Pamplona, Navarra, Spain, 31008
Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia
Barcelona, Spain, 08025
Hospital Universitario La Princesa, Servicio dermatologia
Madrid, Spain, 28006
HUGregorio Marañón, Servicio de dermatología
Madrid, Spain, 28007
Hospital Ramon y Cajal; servicio dermatologia
Madrid, Spain, 28034
Hospital Universitario La Paz; Servicio de dermatologia
Madrid, Spain, 28046
Hospital General Universitario de Valencia; servicio de dermatología
Valencia, Spain, 46014
Switzerland
Inselspital Bern; Dermatologie
Bern, Switzerland, 3000
CHUV; Dermatologie
Lausanne, Switzerland, 1011
Universitätsspital Zürich; Dermatologische Klinik
Zürich, Switzerland, 8091
Taiwan
Chang Gung Medical Foundation;Kaohsiung Branch; Department of Dermatology
Kaohsiung, Taiwan, 83301
National Cheng-Kung University Hospital; Department of Dermatology
Tainan, Taiwan, 70403
National Taiwan University Hospital; Department of Dermatology
Taipei, Taiwan, 10048
United Kingdom
Russells Hall Hospital
Dudley, United Kingdom, DY1 2HQ
Guys and St Thomas NHS Foundation Trust, Guys Hospital; Skin Therapy Research Unit
London, United Kingdom, SE1 9RT
Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE1 4LP
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Poole Hospital
Poole, United Kingdom, BH15 2JB
Salford Royal NHS Foundation Trust
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02340234     History of Changes
Other Study ID Numbers: GS29250
2014-000049-56 ( EudraCT Number )
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrocortisone
Antibodies, Monoclonal
Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs