atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Almirall, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults and adolescents (aged =12 to =65 years) no F.1.3.1 Number of subjects for this age range
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 weeks 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-?, 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 18 weeks of the Baseline visit, planned during the study, or 12 weeks after the study treatment is discontinued 8. History of anaphylaxis as defined by the Sampson criteria 9. Regular use (more than 2 visits per week) of a tanning booth/parlor 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 etiology 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 judgement 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 chemistry, haematology, or urinalysis tests obtained at the Screening visit 19. Presence of skin comorbidities that may interfere with study assessments 20. History of malignancy, including mycosis fungoides, within 5 years before the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of lebrikizumab compared with placebo in patients not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16;Secondary Objective: To evaluate the efficacy in patients not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable between Week 16 up to Week 52.;Primary end point(s): Percentage of patients achieving EASI 75 (=75% reduction from Baseline in EASI score) at Week 16.;Timepoint(s) of evaluation of this end point: week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients achieving IGA 0/1 and 2-point improvement at Week 16.a • Percentage of patients achieving a 4-point improvement Pruritus NRS at Week 16.a • Percentage of patients achieving EASI 90 at Week 16. • Percentage patients achieving EASI 75, EASI 90 and EASI 50 (by visit up to Week 16) • Change from Baseline by visit up to Week 16 in BSA, SCORAD, Pruritus NRS, sleep loss, POEM, DLQI/CDLQI, and Skin Pain NRS • Percentage of 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 • Percentage of patients achieving a 4-point improvement Skin Pain NRS at Week 16. Extension Period: - Percentage of patients achieving EASI 75, EASI 90, EASI 50; IGA 0/1 and 2-point improvement, and 4-point improvement Pruritus NRS by visit. - Change from Baseline in BSA, SCORAD, Pruritus NRS, sleep loss, DLQI/CDLQI, and Skin Pain NRS by visit. - Percentage of patients achieving a 4-point improvement in DLQI/CDLQI by visit. - Incidence of AEs by visit. AEs includes TEAEs, SAEs, Related TEAEs, Related SAEs, TEAEs leading to study treatment discontinuation, AESIs and Deaths. - Observed results and changes from Baseline in Laboratory Results (Haematology, Chemistry and Urinalysis) by visit. - Observed results and changes from Baseline in Vital Signs Results by visit. - Percentage of patients with abnormalities in physical examination by visit. ;Timepoint(s) of evaluation of this end point: week 16 | — |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain
Contacts
Public ContactClinical Trials Information
Almirall, S.A.
Outcome results
None listed