A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps

Part of paid clinical trials in La Jolla, California.

Sponsor
Sanofi
Study ID
NCT06454240
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • lunsekimig — DRUG
    Pharmaceutical form:solution for injection-Route of administration:subcutaneous
  • placebo — DRUG
    Pharmaceutical form:solution for injection-Route of administration:subcutaneous

Study Details

This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups. The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.

Key Dates

Start date
Jul 17, 2024
Status verified
Apr 2026
Primary completion
Jan 29, 2026
Completion
Apr 23, 2026

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1
    Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.
  • Experimental: Arm 2
    Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.

Primary Outcome Measure

Change in bilateral endoscopic nasal polyp score (NPS). [ Time Frame: From baseline to Week 24 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Allergy & Rheumatology- Site Number : 8400005La JollaCalifornia92037-
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003RosevilleCalifornia95661-
Senta Clinic- Site Number : 8400025San DiegoCalifornia92018-
James A Haley Veterans' Hospital- Site Number : 8400015TampaFlorida33612-
Emory University Hospital Midtown- Site Number : 8400012AtlantaGeorgia30308-
The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002BoiseIdaho83706-
Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016BostonMassachusetts02115-
Essential Medical Research- Site Number : 8400020TulsaOklahoma74137-
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017BellaireTexas77401-
Gary Gross Pharmaceutical Research & Consulting, Inc. Site Number : 8400004DallasTexas75231-
Berkson Medical - McKinney- Site Number : 8400014McKinneyTexas75070-
Alamo ENT Associates Site Number : 8400001San AntonioTexas78258-
Advanced Research Institute - Odgen- Site Number : 8400022OgdenUtah84405-
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008NorfolkVirginia23510-

Find similar trials in La Jolla, CA

By research site
Allergy & Rheumatology· La Jolla, CASacramento Ear Nose & Throat - Roseville· Roseville, CASenta Clinic· San Diego, CAJames A Haley Veterans' Hospital· Tampa, FLEmory University Hospital Midtown· Atlanta, GAThe Allergy Group - Asthma & Allergy Boise· Boise, ID

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