Atopic DermatitisPhase 2NCT02340234
A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis
A Phase 2 study testing Lebrikizumab and TCS Cream in people with Atopic Dermatitis, run by Hoffmann-La Roche at 74 sites in 14 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lebrikizumab and TCS Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 74 sitesin 14 countries
- Study dates
- May 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
74 sites in 14 countries.
74 sites in 14 countries
United States16 sites
University of Colorado; Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, 60611
University of Texas Medical School-Houston
Houston, Texas, 77030
University of Iowa Healthcare; Dermatology
Iowa City, Iowa, 52242
Dermatology Research Associate
Los Angeles, California, 90045
Sadick Research Group
New York, New York, 10075
Virginia Clinical Research Inc.
Norfolk, Virginia, 23502
Ameriderm Research
Ormond Beach, Florida, 32174
Oregon Health & Science University; Department of Dermatology
Portland, Oregon, 97239-4501
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
UCSD Division of Dermatology
San Diego, California, 92122
Univ of Calif-San Francisco
San Francisco, California, 94115
Washington University; Dermatology
St Louis, Missouri, 63110
Olympian Clinical Research
Tampa, Florida, 33609
Somerset Skin Centre
Troy, Michigan, 48084
Canada7 sites
Institute for Skin Advancement
Calgary, Alberta, T3A 2N1
Innovaderm Research Inc.
Montreal, Quebec, L2K 4L5
Dr. Melinda Gooderham Medicine Professional Corporation
Peterborough, Ontario, K9J 5K2
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
XLR8 Medical Research Inc.
Windsor, Ontario, N8W 1E6
Spain7 sites
Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia
Barcelona, 08025
Hospital Universitario La Princesa, Servicio dermatologia
Madrid, 28006
HUGregorio Marañón, Servicio de dermatología
Madrid, 28007
Hospital Ramon y Cajal; servicio dermatologia
Madrid, 28034
Hospital Universitario La Paz; Servicio de dermatologia
Madrid, 28046
Clinica Universitaria de Navarra; Servicio de Dermatologia
Pamplona, Navarre, 31008
Hospital General Universitario de Valencia; servicio de dermatología
Valencia, 46014
Germany6 sites
Charite Mitte; Klinik fur Dermatologie
Berlin, 10117
Universitätsklinik Bonn
Bonn, 53127
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt, 60590
SRH Wald-Klinikum Gera GmbH; Hautkrankheiten und Allergologie
Gera, 07548
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
Kiel, 24105
Universitätsklinikum Mainz
Mainz, 55131
United Kingdom6 sites
Russells Hall Hospital
Dudley, DY1 2HQ
Guys and St Thomas NHS Foundation Trust, Guys Hospital; Skin Therapy Research Unit
London, SE1 9RT
Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP
Churchill Hospital
Oxford, OX3 7LJ
Poole Hospital
Poole, BH15 2JB
Salford Royal NHS Foundation Trust
Salford, M6 8HD
France5 sites
Hopital Saint Andre CHU De Bordeaux; Dermatologie
Bordeaux, 33075
Hopital du Bocage; Dermatologie
Dijon, 21079
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
Nantes, 44093
Hopital l Archet 2; Ginestriere, Service de; Dermatologie
Nice, 06200
Centre Hospitalier Lyon Sud; Dermatologie
Pierre-Bénite, 69495
Poland5 sites
Uniwersyteckie Centeum Kliniczne GUMed; Klinika Dermatologii, Wenerologii i Alergologii
Gdansk, 80-402
DERMED Centrum Medyczne; Sp zoo
Lodz, 90-265
Laser Clinic
Szczecin, 70-322
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
Tarnów, 33-100
dermMedica sp.z o.o.
Wroclaw, 51-318
Australia4 sites
Skin & Cancer Foundation
Carlton, Victoria, 3053
Fremantle Dermatology
Fremantle, Western Australia, 6160
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217
Royal Melbourne Hospital; Dermatology Department
Parkville, Victoria, 3050
Czechia3 sites
Faculty Hospital; Department of Dermatology
Pilsen, 305 99
Charles University School of Medicine; Deptartment of Dermatology
Prague, 100 34
Masarykova nemocnice o.z; kozni oddeleni
Ústí nad Labem, 401 13
Finland3 sites
Helsinki University Central Hospital; Skin & Allergy Hospital
Helsinki, 00029
Tampere University Hospital; Dermatology and allergology
Tampere, 33520
Turku Central University Hospital; Dermatology and allergology
Turku, 20250
Netherlands3 sites
Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center
Amsterdam, 1100 DD
University Medical Center Groningen; Department of Dermatology
Groningen, 9700RB
UMC Utrecht; Dermatology
Utrecht, 3584 CX
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
ChungAng University Hospital
Seoul, 06973
Switzerland3 sites
Inselspital Bern; Dermatologie
Bern, 3000
CHUV; Dermatologie
Lausanne, 1011
Universitätsspital Zürich; Dermatologische Klinik
Zurich, 8091
Taiwan3 sites
Chang Gung Medical Foundation;Kaohsiung Branch; Department of Dermatology
Kaohsiung City, 83301
National Cheng-Kung University Hospital; Department of Dermatology
Tainan, 70403
National Taiwan University Hospital; Department of Dermatology
Taipei, 10048
About this study
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
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Lebrikizumab, Placebo, TCS Cream
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Lebrikizumab will be administered SC as per the schedule specified in the respective arms.
PlaceboDrug
Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
TCS CreamDrug
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab 250 mg Single Dose + TCS Cream | Experimental | 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. Receives: Drug: Lebrikizumab; Drug: Placebo; Drug: TCS Cream |
| Lebrikizumab 125 mg Single Dose + TCS Cream | Experimental | 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. Receives: Drug: Lebrikizumab; Drug: Placebo; Drug: TCS Cream |
| Lebrikizumab 125 mg Q4W + TCS Cream | Experimental | 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. Receives: Drug: Lebrikizumab; Drug: TCS Cream |
| Placebo Q4W + TCS Cream | Placebo comparator | 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. Receives: Drug: Placebo; Drug: TCS Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50) at Week 12
Measured: Week 12
Secondary outcomes (39)
Percent Change From Baseline in EASI Score at Week 12
Measured: Baseline, Week 12
Absolute Change From Baseline in EASI Score at Week 12
Measured: Baseline, Week 12
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12
Measured: Week 12
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12
Measured: Week 12
Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12
Measured: Week 12
Absolute Change From Baseline in IGA at Week 12
Measured: Baseline, Week 12
Percentage of Participants Achieving an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12
Measured: Week 12
Percentage of Participants with a >/=2 Point Reduction From Baseline in IGSA at Week 12
Measured: Week 12
Absolute Change From Baseline in IGSA at Week 12
Measured: Baseline, Week 12
Percent Change From baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12
Measured: Baseline, Week 12
Absolute Change From baseline in SCORAD at Week 12
Measured: Baseline, Week 12
Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD-50/75 at Week 12
Measured: Week 12
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16
Measured: Weeks 12, 16
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 and 20
Measured: Weeks 12, 16, 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
Measured: Weeks 12, 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
Measured: Weeks 12, 16, 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
Measured: Weeks 12, 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
Measured: Weeks 12, 16, 20
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16
Measured: Weeks 12, 16
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 and 20
Measured: Weeks 12, 16, 20
Percent Change From Baseline in Total % Body Surface Area (BSA) Affected At Week 12
Measured: Baseline, Week 12
Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12
Measured: Baseline, Week 12
Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12
Measured: Baseline, Week 12
Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Measured: Baseline, Week 12
Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Measured: Baseline, Week 12
Total Use (Grams) of TCS From Baseline to Week 12
Measured: From Baseline to Week 12
Total Use (Grams) of TCS From Week 12 to End of Study or Early Termination
Measured: From Week 12 to end of study or early termination (up to approximately 20 weeks)
Number of Disease Flares From Baseline to Week 12
Measured: From Baseline to Week 12
Change in AD Symptoms From Baseline to Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD)
Measured: Baseline, Week 12
Change in AD-Specific HealthRelated Quality of Life (QoL) From Baseline to Week 12, as Assessed by the Atopic Dermatitis Impact Questionnaire (ADIQ)
Measured: Baseline, Week 12
Change in Health-Related QoL From Baseline to Week 12, as Measured by the Dermatology Life Quality Index (DLQI)
Measured: Baseline, Week 12
Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
Measured: From start of run-in period (Day -14) until study completion (up to approximately 20 Weeks)
Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Lebrikizumab
Measured: Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141)
Percentage of Participants With ATA to Phospholipase B-Like 2 (PLBL2) Protein
Measured: Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141)
Percentage of Participants With Disease Rebound
Measured: From Week 12 up to approximately 20 weeks
Maximum Serum Concentration (Cmax) of Lebrikizumab
Measured: After first dose of lebrikizumab at Week 1
Time to Reach Cmax (Tmax) of Lebrikizumab
Measured: After first dose of lebrikizumab at Week 1
Minimum Serum Concentration (Cmin) of Lebrikizumab
Measured: Pre-dose at Weeks 4, 8, 12
Elimination Half-Life (t1/2) of Lebrikizumab
Measured: Pre-dose on Days 1, 8, 29, 43, 57, 85, 113, 141, study discontinuation visit (up to Day 141)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340234
- Sponsor's protocol ID
- GS29250
- Other IDs
- 2014-000049-56, 2014
- Status last verified
- Sep 2017
- First submitted
- 13 Jan 2015
- Last updated
- 2 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02340234
- Acronym / sponsor ID
- GS29250
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lebrikizumab 250 mg Single Dose + TCS Cream | Experimental | Drug: Lebrikizumab, Drug: Placebo, Drug: TCS CreamParticipants 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. |
| Lebrikizumab 125 mg Single Dose + TCS Cream | Experimental | Drug: Lebrikizumab, Drug: Placebo, Drug: TCS CreamParticipants 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. |
| Lebrikizumab 125 mg Q4W + TCS Cream | Experimental | Drug: Lebrikizumab, Drug: TCS CreamParticipants 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 Q4W + TCS Cream | Placebo comparator | Drug: Placebo, Drug: TCS CreamParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LebrikizumabLebrikizumab will be administered SC as per the schedule specified in the respective arms. | Drug | Lebrikizumab 125 mg Q4W + TCS Cream, Lebrikizumab 125 mg Single Dose + TCS Cream, Lebrikizumab 250 mg Single Dose + TCS Cream |
| PlaceboPlacebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms. | Drug | Lebrikizumab 125 mg Single Dose + TCS Cream, Lebrikizumab 250 mg Single Dose + TCS Cream, Placebo Q4W + TCS Cream |
| TCS CreamTCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily | Drug | Lebrikizumab 125 mg Q4W + TCS Cream, Lebrikizumab 125 mg Single Dose + TCS Cream, Lebrikizumab 250 mg Single Dose + TCS Cream, Placebo Q4W + TCS Cream |
Primary outcome
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
39 secondary outcomes
Percent Change From Baseline in EASI Score at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in EASI Score at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12
Time frame: Week 12
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12
Time frame: Week 12
Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12
Time frame: Week 12
Absolute Change From Baseline in IGA at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Achieving an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12
Time frame: Week 12
Percentage of Participants with a >/=2 Point Reduction From Baseline in IGSA at Week 12
Time frame: Week 12
Absolute Change From Baseline in IGSA at Week 12
Time frame: Baseline, Week 12
Percent Change From baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12
Time frame: Baseline, Week 12
Absolute Change From baseline in SCORAD at Week 12
Time frame: Baseline, Week 12
Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD-50/75 at Week 12
Time frame: Week 12
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16
Time frame: Weeks 12, 16
Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 and 20
Time frame: Weeks 12, 16, 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
Time frame: Weeks 12, 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
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
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
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16
Time frame: Weeks 12, 16
Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 and 20
Time frame: Weeks 12, 16, 20
Percent Change From Baseline in Total % Body Surface Area (BSA) Affected At Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12
Time frame: Baseline, Week 12
Total Use (Grams) of TCS From Baseline to Week 12
Time frame: From Baseline to Week 12
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)
Number of Disease Flares From Baseline to Week 12
Time frame: From Baseline to Week 12
Change in AD Symptoms From Baseline to Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD)
Time frame: Baseline, Week 12
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
Change in Health-Related QoL From Baseline to Week 12, as Measured by the Dermatology Life Quality Index (DLQI)
Time frame: Baseline, Week 12
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)
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)
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)
Percentage of Participants With Disease Rebound
Time frame: From Week 12 up to approximately 20 weeks
Maximum Serum Concentration (Cmax) of Lebrikizumab
Time frame: After first dose of lebrikizumab at Week 1
Time to Reach Cmax (Tmax) of Lebrikizumab
Time frame: After first dose of lebrikizumab at Week 1
Minimum Serum Concentration (Cmin) of Lebrikizumab
Time frame: Pre-dose at Weeks 4, 8, 12
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
74 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lebrikizumab and TCS Cream in people with Atopic Dermatitis, run by Hoffmann-La Roche at 74 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Canada, Spain, Germany, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.