atopic dermatitis eczema
Conditions
Interventions
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 64 Years
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
Exclusion criteria
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;- 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 investigators 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome measure is the percentage of patients achieving EASI-50 (a 50% reduction in EASI score from baseline) at Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Outcome Measures The secondary efficacy outcome measures for this study are as follows: • Percent and absolute change from baseline in EASI score at Week 12 • Percent of patients achieving a 75% reduction from baseline in EASI score (EASI-75) at Week 12 • Percent of patients achieving an IGA score of 0 or 1 at Week 12 • Percent of patients with a >= 2 point reduction from baseline in IGA at Week 12 • Absolute change from baseline in IGA at Week 12 • Percent of patients achieving an IGSA score of 0 or 1 at Week 12 • Percent of patients with a >= 2 point reduction from baseline in IGSA at Week 12 • Absolute change from baseline in IGSA at Week 12 • Percent and absolute change from baseline in SCORAD at Week 12 • Percent of patients with a 50% or 75% reduction from baseline in SCORAD-50/75 at Week 12 • Percent of patients achieving EASI-50 at Week 12 and maintaining EASI-50 at Weeks 16 and 20 • Percent of patients achieving IGA score of 0 or 1 at Week 12 and maintaining IGA score of 0 or 1 at Weeks 16 and 20 • Percent of patients achieving IGSA score of 0 or 1 at Week 12 and maintaining IGSA score of 0 or 1 at Weeks 16 and 20 • Percent of patients achieving SCORAD-50 at Week 12 and maintaining SCORAD-50 at Weeks 16 and 20 • Percent change from baseline in total % body surface area (BSA) affected at Week 12 • Absolute- and percent-change from baseline in pruritus as measured by the Pruritus VAS (assessed as part of the SCORAD) at Week 12 • Absolute- and percent-change from baseline in pruritus as measured by the 5-D Itch Scale at Week 12 • Total use (grams) of TCS from baseline to Week 12 • Total use (grams) of TCS from Week 12 to end of study or early termination • Number of disease flares from baseline to Week 12 • Change in AD symptoms from baseline to Week 12, as assessed by the ADSD • Change in AD-specific health-related QoL from baseline to Week 12, as assessed by the ADIQ • Change in health-related QoL from baseline | — |
Countries
Australia, Canada, Czechia, Finland, France, Germany, Korea (the Republic of), Netherlands, Poland, Spain, Switzerland, Taiwan (Province of China), United Kingdom, United States of America
Outcome results
None listed