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.

Participants can expect study participation to last up to 29.5 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: 2025-11
• Last Update Submitted: 2025-11-04
• Last Update Posted: 2025-11-05
• Primary Completion: 2026-09
• Study Completion: 2028-10-01

Recruitment & Eligibility

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

Inclusion Criteria

• Physician-diagnosed perennial allergic rhinitis (PAR).
• Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
• The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum antigen-specific IgE test.
• A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific 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 AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible.

• Have received treatment with any rescue medication during the run-in period.

• Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease prior to the baseline visit:

  • Any current or prior use of biologics indicated for asthma or AD are prohibited.
  • B cell-depleting biologics, including rituximab, within 6 months.
  • Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
  • Systemic immunosuppressants, including JAK inhibitors, 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 8 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 Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain 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 RQLQ(S) Activities Domain 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 RQLQ(S) Total Score 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 RQLQ(S) Total Score 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 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 (69)

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

Allergy and Asthma Diagnostic Center; 🇺🇸 Tallahassee, Florida, United States

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

Northwestern University; 🇺🇸 Chicago, Illinois, United States

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

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

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