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

Phase 3

Recruiting

• Conditions: Perennial Allergic Rhinitis (PAR)
• Interventions: Drug: LY3650150; Drug: Placebo; Drug: Standard therapy for INCS

• Registration Number: NCT06339008
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-01
• Study Start: 2024-04-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-10
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Physician-diagnosed PAR.
• Has a positive skin prick test (SPT) with indoor allergens and/or positive antigen-specific serum immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
• A dermatographic participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum IgE test.
• Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.

Exclusion Criteria

• Have received a dose of lebrikizumab.

• Is currently on allergen immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy (SCIT/SLIT) for ≥3 years prior to randomization are eligible, if they were not on a maintenance allergen immunotherapy (AIT) regimen.

• Have received treatment with any rescue medication during the screening and/or run-in period.

• Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:

  1. B cell-depleting biologics, including rituximab, within 6 months.
  2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
  3. Systemic immunosuppressants within 4 weeks prior to baseline.

• Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 4 weeks of the maintenance period.

• Anticipates significant changes in their daily environmental exposure

• Has a known history of recurrent acute or chronic sinusitis,

• Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lebrikizumab Q2W/every 8 weeks (Q8W)	LY3650150	Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Lebrikizumab Q2W/every 8 weeks (Q8W)	Standard therapy for INCS	Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)	Standard therapy for INCS	Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)	LY3650150	Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Placebo Q2W/Q4W	Placebo	Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Placebo Q2W/Q4W	Standard therapy for INCS	Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Mean CFBL in RQLQ(S) at week 56	Baseline, 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)
Mean CFBL in TNSS at Week 4	Baseline, 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.
Mean CFBL in TNSS at Week 56	Baseline, 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.
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at week 16	Baseline, 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).
Mean CFBL in Postnasal drip score at Week 16	Baseline, 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.

Trial Locations

Locations (64)

Allergy and Asthma Specialists Medical Group; 🇺🇸 Huntington Beach, California, United States

310 Clinical Research; 🇺🇸 Inglewood, California, United States

Allergy & Asthma Associates of Southern California dba. Southern California Research; 🇺🇸 Laguna Niguel, California, United States

Allergy and Asthma; 🇺🇸 San Diego, California, United States

Asthma and Allergy Associates, PC; 🇺🇸 Colorado Springs, Colorado, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Asthma Allergy Center of Chicago; 🇺🇸 Chicago, Illinois, United States

Bluegrass Allergy Research; 🇺🇸 Lexington, Kentucky, United States

Respiratory Medicine Research Institute of Michigan, PLC; 🇺🇸 Ypsilanti, Michigan, United States

Clinical Research Institute; 🇺🇸 Minneapolis, Minnesota, United States

Scroll for more (54 remaining)