RecruitingPhase 3

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

United States510 participantsStarted 2024-04-29

Plain-language summary

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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and
✓. At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.

Exclusion criteria

✕. 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 within 4 weeks prior to baseline.
✕. Nasal septal deviation occluding at least one nostril.
✕. Antrochoanal polyps.
✕. Acute sinusitis, acute nasal infection, or acute upper respiratory infection.
✕. Ongoing rhinitis medicamentosa.
✕. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.

What they're measuring

Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity

Timeframe: Baseline, Week 24

Mean CFBL in Endoscopic Nasal Polyp Score (NPS)

Timeframe: Baseline, Week 24

Trial details

NCT IDNCT06338995

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

View on ClinicalTrials.gov More Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) trials