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Monoclonal Antibodies

Lebrikizumab for Allergic Rhinitis

Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 56
Awards & highlights
Pivotal Trial

Summary

"This trial aims to test if lebrikizumab is effective and safe for adults with year-round allergic rhinitis. The study will take around 13 months to complete."

Who is the study for?
This trial is for adults with year-round nasal allergies. Participants should have a history of symptoms or a positive allergy test. Specific details on who can't join are not provided, but typically those with other significant health issues or taking conflicting medications would be excluded.
What is being tested?
The study tests lebrikizumab (LY3650150), given as an injection under the skin (SC), to see if it's effective and safe in treating perennial allergic rhinitis over approximately 13 months.
What are the potential side effects?
While specific side effects aren't listed here, similar medications often cause reactions at the injection site, headaches, fatigue, and possible immune system effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16
Secondary study objectives
Mean CFBL in Postnasal drip score at Week 16
Mean CFBL in RQLQ(S) at week 56
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at week 16
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)Experimental Treatment2 Interventions
Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Group II: Lebrikizumab Q2W/every 8 weeks (Q8W)Experimental Treatment2 Interventions
Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Group III: Placebo Q2W/Q4WPlacebo Group2 Interventions
Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.

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Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,676 Previous Clinical Trials
3,463,577 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
426,944 Total Patients Enrolled
~187 spots leftby May 2025
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