This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months.
Participants who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study (parent study), DRM06-AD04 (NCT04146363), DRM06-AD05 (NCT04178967), DRM06-AD06 (NCT04250337), DRM06-AD17 (NCT04250350) or DRM06- AD18 (NCT04626297), will be offered the opportunity to enroll in this study. Participants may either be blinded or not blinded, depending on their parent study assignment. This study will also be open to an additional approximately 100 participants in the United States (addendum) who have not completed participation in a Dermira- or Lilly-sponsored lebrikizumab study. Treatment will not be blinded. This study will also include an Addendum to extend the study treatment period by an additional 32 weeks and to add a treatment arm testing dosing every 8 weeks. This Addendum will apply to existing study participants in selected countries. Treatment will not be blinded.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,153
Subcutaneous injection
Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events
Percentage of participants discontinued from study treatment due to adverse events is reported.
Time frame: Baseline to Week 100
Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100
The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point.
Time frame: Week 100
Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity.
Time frame: Week 100
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Clinical Research Center of Alabama- Birmingham
Birmingham, Alabama, United States
Investigate MD
Scottsdale, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Arkansas Research Trials
North Little Rock, Arkansas, United States
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States
Orange County Research Institute
Anaheim, California, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States
Wallace Medical Group, Inc.
Beverly Hills, California, United States
...and 311 more locations