Clinical trial NCT06339008: A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/ LY3650150 in Adult Participants With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis (PAR)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-04-01
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at week 16
timeFrame: Baseline, Week 16
measure: Mean CFBL in RQLQ(S) at week 56
timeFrame: Baseline, Week 56
measure: Mean CFBL in TNSS at Week 4
timeFrame: Baseline, Week 4
measure: Mean CFBL in TNSS at Week 56
timeFrame: Baseline, Week 56
measure: Mean CFBL in Postnasal drip score at Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialists Medical Group
state: California
city: Inglewood
country: United States
facility: 310 Clinical Research
state: California
city: Laguna Niguel
country: United States
facility: Allergy & Asthma Associates of Southern California dba. Southern California Research
state: California
city: San Diego
country: United States
facility: Allergy and Asthma
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, PC
state: Colorado
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Asthma Allergy Center of Chicago
state: Illinois
city: Lexington
country: United States
facility: Bluegrass Allergy Research
state: Kentucky
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan, PLC
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Allergy and Asthma Consultants
state: Missouri
city: Bellevue
country: United States
facility: Asthma and Allergy Center
state: Nebraska
city: Hamilton
country: United States
facility: Circuit Clinical/Mercer Allergy and Pulmonary Associates
state: New Jersey
city: Secaucus
country: United States
facility: Circuit Clinical
state: New Jersey
city: Teaneck
country: United States
facility: Dr. Patrick Perin
state: New Jersey
city: Horseheads
country: United States
facility: Smith Allergy and Asthma
state: New York
city: Asheville
country: United States
facility: Allergy Partners
state: North Carolina
city: Asheville
country: United States
facility: Allergy Partners
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Kerrville
country: United States
facility: Kerrville Allergy and Asthma Associates
state: Texas
city: Greenfield
country: United States
facility: Allergy, Asthma & Sinus Center
state: Wisconsin
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Brussels
country: Belgium
facility: Hôpital Erasme, Service Pharmacie
city: Erpent
country: Belgium
facility: Pneumocare
city: Leuven
country: Belgium
facility: UZ Leuven, Pharmacy
city: Liège
country: Belgium
facility: Hôpital de la Citadelle
city: Wu Han
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Beijing
country: China
facility: Internal Medicine Building
city: Beijing
country: China
facility: Department of Nasal Allergy
city: Guangzhou City
country: China
facility: GCP Pharmacy
city: Guangzhou City
country: China
facility: GCP Pharmacy
city: Hangzhou City
country: China
facility: Zhejiang People's Hospital
city: Nanhu District
country: China
facility: Shengjing Hospital
city: Shanghai
country: China
facility: Tongji Hospital
city: Wuhan City
country: China
facility: Outpatient building
city: Wuhan
country: China
facility: Outpatient Department, Union Hospital
city: Yangzhou City
country: China
facility: Yangzhou University
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Klinik für Dermatologie
city: Dresden
country: Germany
facility: Praxis für HNO und Allergologie
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU
city: Frankfurt am Main
country: Germany
facility: IKF Pneumologie
city: Heidelberg
country: Germany
facility: Siteworks - Zentrum für klinische Studien Heidelberg
city: Marburg
country: Germany
facility: Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
city: Weisbaden
country: Germany
facility: Zentrum für Rhinologie und Allergologie
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital at Gangdong
state: Seoul, Korea
city: Incheon
country: Korea, Republic of
facility: B1F, Pharmacy department, Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital 211
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Clinical trial Pharmacy
city: Warszawa
country: Poland
facility: ETG Warszawa
state: Mazowieckie
city: Kielce
country: Poland
facility: Polimedica PTG Kielce
city: Krakow
country: Poland
facility: Centrum Medyczne Promed ul. Olszańska 5G
city: Lodz
country: Poland
facility: gab. 114, ul. inż. pilota Wigury
city: Lublin
country: Poland
facility: ETG Lublin
city: Lublin
country: Poland
facility: ETG Lublin
city: Pila
country: Poland
facility: Centrum Alergologii Teresa Hofman Sp z.o.o.
city: Rzeszow
country: Poland
facility: EMED Centrum Usług Medycznych
city: Skierniewice
country: Poland
facility: ClinMedica Research
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
city: Wroclaw
country: Poland
facility: ALL-MED - Specjalistyczna Opieka Medyczna
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: