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

Conditions

• Perennial Allergic Rhinitis (PAR)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LY3650150 — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC
• Standard therapy for INCS — DRUG
  Administered as intranasal spray

Study Details

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.

Key Dates

Start date

Apr 26, 2024

Status verified

Apr 2026

Primary completion

Sep 30, 2026

Completion

Oct 31, 2028

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
  Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
• Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W)
  Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
• Placebo Comparator: Placebo Q2W/Q4W
  Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.

Primary Outcome Measure

Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16 [ Time Frame: Baseline, Week 16 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (27)

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