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. The study will last about 18 months

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

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