Clinical trial NCT02340234 (phase 2, status: completed)
Conditions: atopic dermatitis
ICD codes: L20.89, L20.9
Drugs: lebrikizumab, placebo, tcs cream
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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