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

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Perennial Allergic Rhinitis (PAR)

Treatments: Drug: Placebo; Drug: LY3650150; Drug: Standard therapy for INCS

Study type: Interventional

Funder types: Industry

Identifiers

NCT06339008

2023-508817-18-00 (Other Identifier)

18789

J2T-MC-KGBT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 3 patient groups, including a placebo group

Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)

Experimental group

Description:

Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).

Treatment:

Drug: Standard therapy for INCS

Drug: LY3650150

Lebrikizumab Q2W/every 8 weeks (Q8W)

Experimental group

Description:

Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.

Treatment:

Drug: Standard therapy for INCS

Drug: LY3650150

Placebo Q2W/Q4W

Placebo Comparator group

Description:

Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.

Treatment:

Drug: Standard therapy for INCS

Drug: Placebo