LEBRIKIZUMAB for Perennial allergic rhinitis

Inclusion criteria

• {"criterion_text":"- • Physician-diagnosed PAR.\n- • 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).\n- • A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive antigen-specific IgE test.\n- • Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment."}

Exclusion criteria

• {"criterion_text":"- • Have received a dose of lebrikizumab.\n- • Is currently on allergen immunotherapy (AIT). However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible.\n- • Have received treatment with any rescue medication during the run-in period.\n- • Have received treatment with any biologic or systemic immunosuppressants, including Janus kinase inhibitors for inflammatory disease or autoimmune disease prior to baseline visit: a. Any current or prior use of biologics indicated for asthma or AD are prohibited. b. B cell-depleting biologics, including rituximab, within 6 months. c. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer. d. Systemic immunosuppressants, including Janus kinase inhibitors, within 4 weeks prior to baseline.\n- • 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.\n- • Anticipates significant changes in their daily environmental exposure\n- • Has a known history of recurrent acute or chronic sinusitis\n- • Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study."}

Primary endpoints

• {"endpoint_text":"- 1. Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at 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. [Time Frame: Baseline, Week 16]","definition_or_measurement_approach":"Total Nasal Symptom Score (TNSS) is a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom scored 0 = none, 1 = mild, 2 = moderate, 3 = severe; total score range 0–12. Primary measure: Mean change from baseline to Week 16. Time frame: Baseline and Week 16."}

Methods

• Social media campaigns (materials listed: Social-1080x1080, Social-1200x628, Social-1200x640) — country-specific variants available (Poland, Germany, Belgium).
• Email campaigns (Email templates and Email-Banner assets) — country-specific (PL, DE, BE).
• SMS messages (SMS templates) — country-specific (PL, DE).
• Landing pages and URLs (Landing-Page_PL, Landing-Page_DE, URLs_PL) for online recruitment and prescreening.
• Doctor-to-patient letters and site-based recruitment materials (Doctor-to-Patient-Letter in PL/DE/BE) distributed via clinics/sites.
• Printed materials and onsite assets: Posters, Flipcharts, Patient-Recruitment-Brochure, Prescreener forms, Banner images for sites.
• Telephone outreach scripts (LONG-LIVE-DIAL-SCRIPT / Long-Live-Dial-Script) and call-center materials.
• Keyword-search guidance and online advertising (KEYWORD-SEARCH_PL, Keyword-Search_DE).

Poland

Earliest CTIS Part Ii Submission Date

04-07-2024

Latest Decision Or Authorization Date

11-08-2025

Processing Time Days

403

Number Of Sites

12

Number Of Participants

107

Germany

Earliest CTIS Part Ii Submission Date

05-07-2024

Latest Decision Or Authorization Date

04-08-2025

Processing Time Days

395

Number Of Sites

7

Number Of Participants

116

Belgium

Earliest CTIS Part Ii Submission Date

02-07-2024

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

394

Number Of Sites

5

Number Of Participants

35

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

[{"id":808517,"code":"1"},{"id":808518,"code":"10"},{"id":808519,"code":"11"},{"id":808520,"code":"12"},{"id":808521,"code":"13"},{"id":808522,"code":"2"},{"id":808523,"code":"5"},{"id":808524,"code":"6"}]

Name

PPD Global Central Labs

Responsibilities

[{"id":808513,"code":"4"}]

Third parties

• {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"[{\"id\":808512,\"code\":\"7\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"[{\"id\":808515,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"[{\"id\":808526,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"[{\"id\":808517,\"code\":\"1\"},{\"id\":808518,\"code\":\"10\"},{\"id\":808519,\"code\":\"11\"},{\"id\":808520,\"code\":\"12\"},{\"id\":808521,\"code\":\"13\"},{\"id\":808522,\"code\":\"2\"},{\"id\":808523,\"code\":\"5\"},{\"id\":808524,\"code\":\"6\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"[{\"id\":808516,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"[{\"id\":808513,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Wuxi Apptec Co. Ltd.","duties_or_roles":"[{\"id\":808525,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"[{\"id\":808514,\"code\":\"7\"}]","organisation_type":"Pharmaceutical company"}