Itepekimab for Chronic Sinusitis with Nasal Polyps

(CEREN2 Trial)

Recruiting at 27 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must be taking: Intranasal corticosteroids

Must not be taking: Systemic corticosteroids

Disqualifiers: Smoking, Severe asthma, Lung disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 52 weeks

210 Participants Needed

Trial Summary

What is the purpose of this trial?

EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older. Study details include: * The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks. * The treatment duration will be up to 52 weeks. * The number of visits will be 9 site visits and 20 phone/home visits.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Adults with chronic rhinosinusitis and nasal polyps for at least a year, who've had worsening symptoms requiring treatment. They must have a certain score on the Nasal Polyp Score and experience loss of smell or runny nose. Women can join if they're not able to bear children or use effective birth control. People who've had sinus surgery for polyps are eligible.

Inclusion Criteria

I have had chronic sinusitis with nasal polyps for at least a year.

I have had severe nasal blockage and either loss of smell or runny nose for over 12 weeks.

I am not pregnant or breastfeeding, and if I can have children, I agree to use effective birth control during the study.

Exclusion Criteria

Participants with a history of a severe systemic hypersensitivity reaction to a mAb

Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint

I have a tumor in my nasal cavity, it could be cancerous or non-cancerous.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive subcutaneous administration of Itepekimab or placebo for 52 weeks as add-on therapy to intranasal corticosteroids

52 weeks

9 site visits, 20 phone/home visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Not specified

Open-label extension (optional)

Participants may transition to the LTS18420 study for continued treatment

56 weeks

Treatment Details

Interventions

• Itepekimab

Trial Overview The trial is testing two doses of Itepekimab (an anti-IL-33 antibody) against a placebo, all in addition to standard nasal corticosteroid sprays over 52 weeks. Participants will be randomly assigned to one of three groups and monitored through clinic and phone visits.

Participant Groups

Group I: Itepekimab low dose Experimental Treatment 3 Interventions

SC administration of Itepekimab low dose for 52 weeks

Group II: Itepekimab high dose Experimental Treatment 2 Interventions

Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks

Group III: Placebo Placebo Group 2 Interventions

SC administration of matching placebo for 52 weeks

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School