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Monoclonal Antibodies

Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) for Allergic Rhinitis

Phase 3

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 56

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16

Secondary outcome measures

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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,149 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,295 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with administering Lebrikizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) to individuals?

"According to our assessment at Power, the safety rating for Lebrikizumab administered every 2 weeks (Q2W) or every 4 weeks (Q4W) is graded as a level 3. This evaluation takes into account that this trial is in Phase 3 and has accumulated data demonstrating both effectiveness and multiple instances of safety verification."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"The current information on clinicaltrials.gov indicates that recruitment for this specific trial is not ongoing. The trial was first listed on April 12, 2024, and the most recent update was made on March 25, 2024. While this particular study is not actively seeking participants currently, there are a total of 60 other trials presently enrolling eligible individuals."

Answered by AI

Do several medical facilities in the area participate in this current clinical investigation?

"Sixteen sites are currently participating in this clinical trial, such as 310 Clinical Research located in Inglewood, Allergy and Asthma center situated in San Diego, and Kerrville Allergy and Asthma Associates based in Kerrville. Additionally, there are another sixteen locations involved in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)

2024. "A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06339008.