eczema inflammation of the skin
Conditions
Interventions
During the 16-week Induction Period, patients will receive either 250 mg
lebrikizumab (loading dose of 500 mg given at Baseline and Week 2) or placebo
by SC injection Q2W. The study drug injection w
Sponsors
Almirall
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Adults and adolescents (aged >=12 to =40 kg) 2. Chronic AD (according to Hanifin and Rajka Criteria*2) that has been present for >=1 year before the Screening visit 3. EASI score >=16 at the Baseline Visit 4. IGA score >=3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit 5. >=10% BSA of AD involvement at the Baseline visit 6. Documented history by a physician of an inadequate response to existing topical medications within 6 months before Screening, defined as: inability to achieve good disease control (eg, not able to achieve IGA
Exclusion criteria
Exclusion criteria: 1. Participation in a prior lebrikizumab clinical study 2. Treatment with IL-4 or IL-13 antagonists biological therapies before the Baseline visit. Exception: previous treatment with dupilumab will be allowed in a subset of patients. A washout of at least 8 weeks before the Baseline visit will be required for this subpopulation 3. Treatment with TCS within 1 week before the Baseline visit 4. Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit 5. Treatment with any of the following agents within 4 weeks before the Baseline visit: a. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-γ, JAK inhibitors, azathioprine, methotrexate, etc.) b. Phototherapy and photochemotherapy (PUVA) for AD 6. Treatment with the following before the Baseline visit: a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer; b. B cell-depleting biologics, including but not limited to rituximab, within 6 months; c. Other biologics within 16 weeks or 5 half-lives (if known), whichever is longer 7. Treatment with a live (attenuated) vaccine within 12 weeks of the Baseline visit, planned during the study, or 18 weeks after the study treatment is discontinued 8. History of anaphylaxis as defined by the Sampson criteria*40 9. Regular use (more than 2 visits per week) of a tanning booth/parlour within 4 weeks of the Screening visit 10. Uncontrolled chronic disease that might require bursts of oral corticosteroids, eg, comorbid severe uncontrolled asthma (defined by an Asthma Control Questionnaire-5 score >=1.5 or a history of >=2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalisation for >24 hours) 11. Have had any of the following types of infection within 3 months of Screening or develop any of these infections before randomisation: a. Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment); b. Opportunistic (as defined in Winthrop et al. 2015). NOTE: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over; c. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer); d. Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis) 12. Have a current or chronic infection with hepatitis B virus 13. Have a current infection with hepatitis C virus (ie, positive for hepatitis C RNA) 14. Have known liver cirrhosis and/or chronic hepatitis of any aetiology 15. Diagnosed active endoparasitic infections or at high risk of these infections 16. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator*s judgment 17. History of HIV infection or positive HIV serology at Screening 18. In the Investigator*s opinion, any clinically significant laboratory test results from the ch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving EASI 75 (>=75% reduction from Baseline in EASI score) at Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Percentage of patients achieving IGA 0/1 and 2-point improvement at Week 16. -Percentage of patients achieving a 4- point improvement Pruritus NRS at Week 16. - % of patients achieving EASI 90 at Week 16. - % patients achieving EASI 75, EASI 90 and EASI 50 (by visit up to Week 16) - Change from Baseline BSA by visit up to Week 16 - Change from Baseline SCORAD by visit up to Week 16 - Change from Baseline Pruritus NRS by visit up to Week 16 - Change from Baseline sleep loss by visit up to Week 16 - Change from Baseline POEM by visit up to Week 16 - Change from Baseline DLQI/CDLQI by visit up to Week 16 - % patients achieving a 4-point improvement DLQI/CDLQI by visit up to Week 16 - Proportion of TCS-free days from Baseline by visit up to Week 16 -Time to TCS-free use (days) up to Week 16 - Change from Baseline Skin Pain NRS by visit up to Week 16 - % patients achieving a 4-point improvement Skin Pain NRS at Week 16. | — |
Countries
Netherlands
Outcome results
None listed