Johnston, Rhode Island 02919

  • Atopic Dermatitis

Purpose:

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.


Criteria:

Inclusion Criteria: 1. Male or female adult and adolescents (≥12 years to <18 years, and weighing ≥40 kg). 2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit. 3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit. 4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit 5. ≥10% body surface area (BSA) of AD involvement at the baseline visit. 6. History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable. Exclusion Criteria: 1. Participation in a prior lebrikizumab clinical study. 2. Treatment with the following prior to the baseline visit: 1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer. 2. Dupilumab within 8 weeks. 3. B-cell-depleting biologics, including to rituximab, within 6 months. 4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer. 3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study. 4. Uncontrolled chronic disease that might require bursts of oral corticosteroids. 5. Evidence of active acute or chronic hepatitis 6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. 7. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. 8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.


NCT ID:

NCT04250337


Primary Contact:

Study Director
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone: 1-317-615-4559
Email: clinicaltrials.gov@lilly.com


Backup Contact:

N/A


Location Contact:

Johnston, Rhode Island 02919
United States

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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