Brief Summary
The primary objective for this study is to evaluate the safety of lebrikizumab compared with Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic Dermatitis (AD) that is inadequately controlled with TCS.
Brief Title
A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis
Categories
Completion Date
Completion Date Type
Actual
Conditions
Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
* Age 18 to 75 years, inclusive, at the start of the run-in period
* 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
* IGA score \>/= 3
* AD involvement of \>/= 10% body surface area
* Pruritus Visual Analog Scale score \>/= 3
Exclusion Criteria:
* Past and/or current use of any anti-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
* Evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis
* 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 HIV infection
* Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the patient 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 ECG or laboratory tests
* 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
* Age 18 to 75 years, inclusive, at the start of the run-in period
* 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
* IGA score \>/= 3
* AD involvement of \>/= 10% body surface area
* Pruritus Visual Analog Scale score \>/= 3
Exclusion Criteria:
* Past and/or current use of any anti-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
* Evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis
* 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 HIV infection
* Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the patient 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 ECG or laboratory tests
* 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
Inclusion Criteria
Inclusion Criteria:
* Age 18 to 75 years, inclusive, at the start of the run-in period
* 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
* IGA score \>/= 3
* AD involvement of \>/= 10% body surface area
* Pruritus Visual Analog Scale score \>/= 3
* Age 18 to 75 years, inclusive, at the start of the run-in period
* 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
* IGA score \>/= 3
* AD involvement of \>/= 10% body surface area
* Pruritus Visual Analog Scale score \>/= 3
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT02465606
Org Class
Industry
Org Full Name
Hoffmann-La Roche
Org Study Id
GS29735
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
An Open-Label Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Persistent, Moderate to Severe Atopic Dermatitis
Primary Outcomes
Outcome Measure
Number of participants with treatment-emergent adverse events (TEAEs)
Outcome Time Frame
From baseline to week 12
Secondary Outcomes
Outcome Time Frame
From baseline to week 20
Outcome Measure
Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies
Outcome Time Frame
within 20 weeks
Outcome Measure
Number of participants with disease rebound following discontinuation of study drug
Outcome Time Frame
Week 12
Outcome Measure
Serum lebrikizumab concentration at Week 12
Outcome Time Frame
Week 4
Outcome Measure
Elimination half-life
Outcome Time Frame
From baseline to week 12
Outcome Measure
Number of participants with skin and other organ system infections
Outcome Time Frame
From baseline to week 12
Outcome Measure
Number of participants with injection site reactions
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741