Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
