(Dermira, 60 Weeks)
(Dermira, 60 Weeks)
Sadick Research Group is conducting a clinical study to evaluate the safety and efficacy of lebrikizumab compared with placebo in patients with moderate-to-severe AD.
Gender: Male and Female
Minimum Age: 12 Years Old
Maximum Age: N/A
Facility Type: Outpatient
Stipend Range: $75 per visit
Study Length: 60 weeks
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as
monotherapy for moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
Eligible adult and adolescent (≥12 to 17 years weighing ≥40 kg) patients with moderate-to- severe atopic dermatitis for at least one year, defined according to the American Academy of Dermatology Consensus Criteria, an Eczema Area and Severity Index Score (EASI) of ≥16, an Investigator Global Assessment (IGA) score of ≥3 and a body surface area (BSA) of ≥10% will be enrolled.
During the 16-week Induction Period, approximately 400 patients will be stratified and randomized 2:1 to either 250 mg lebrikizumab (loading dose of 500 mg given at Baseline and Week 2) or placebo by subcutaneous (SC) injection every 2 weeks (Q2W). All study drug injections will be administered in the clinic.
After completion of the Week 16 visit, patients who have responded to treatment [defined as having an IGA of 0 or 1 or a 75% reduction in EASI from Baseline to Week 16 (EASI-75)] will enter the Maintenance Period and will be re-randomized 2:2:1 to one of the following treatment groups: lebrikizumab 250 mg Q2W, lebrikizumab 250 mg given every four weeks (Q4W), or placebo Q2W. Patients will be instructed to self-administer study drug at home.
Inclusion and Exclusion Criteria
- Male or female adults and adolescents (≥12 years and ≥40 kg).
- Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit
- Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit.
- ≥10% body surface area (BSA) of AD involvement at the baseline visit (Appendix 3).
- History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
- Apply a stable dose of moisturizer at least twice daily for ≥7 days prior to the baseline visit.
- Completed electronic diary entries for pruritus and sleep-loss for a minimum of 4 of 7 days preceding randomization.
Other Trial Details
- Physical exam and assessments of study condition to be provided at no cost by an experienced provider.
- No insurance necessary.
- Compensation will be provided at the end of study participation.