A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

Conditions

• Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Eligibility Criteria

Sex

ALL

Age

12 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 participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.

Key Dates

Start date

Apr 29, 2024

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

510 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 Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). Note: Enrollment of adolescents will be open-label, with all adolescents assigned to the lebrikizumab Q2W/Q4W treatment arm.
• Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W)
  Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.
• Placebo Comparator: Placebo Q2W/Q4W
  Placebo will be given as SC injection. Participants will receive background therapy with INCS.

Primary Outcome Measure

Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity [ Time Frame: Baseline, Week 24 ]

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 (33)

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