The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. Participants can expect study participation to last up to 29.5 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Time frame: Baseline, Week 16
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).
Time frame: Baseline, Week 16
Mean CFBL in RQLQ(S) Activities Domain at Week 56
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment)
Time frame: Baseline, Week 56
Mean CFBL in RQLQ(S) Total Score at Week 16
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).
Time frame: Baseline, Week 16
Mean CFBL in RQLQ(S) Total Score at Week 56
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Allergy and Asthma Specialists Medical Group
Huntington Beach, California, United States
RECRUITING310 Clinical Research
Inglewood, California, United States
RECRUITINGAllergy & Asthma Associates of Southern California dba. Southern California Research
Laguna Niguel, California, United States
RECRUITINGAllergy and Asthma
San Diego, California, United States
RECRUITINGAsthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
RECRUITINGAllergy and Asthma Diagnostic Center
Tallahassee, Florida, United States
NOT_YET_RECRUITINGUniversity of South Florida
Tampa, Florida, United States
NOT_YET_RECRUITINGNorthwestern University
Chicago, Illinois, United States
NOT_YET_RECRUITINGAsthma Allergy Center of Chicago
River Forest, Illinois, United States
RECRUITINGBluegrass Allergy Research
Lexington, Kentucky, United States
RECRUITING...and 67 more locations
Time frame: Baseline, Week 56
Mean CFBL in TNSS at Week 4
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Time frame: Baseline, Week 4
Mean CFBL in TNSS at Week 56
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Time frame: Baseline, Week 56
Mean CFBL in Postnasal Drip Score at Week 16
Postnasal drip is mucus drainage down the throat, as part of their Allergic Rhinitis (AR), will be rated by participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours.
Time frame: Baseline, Week 16