Itepekimab for Chronic Sinusitis with Nasal Polyps
(CEREN2 Trial)

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Sanofi

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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 am 18 years old or older.

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.

+3 more

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.

+9 more

Trial 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

Participant Groups

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.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Itepekimab low doseExperimental Treatment3 Interventions

SC administration of Itepekimab low dose for 52 weeks

Group II: Itepekimab high doseExperimental Treatment2 Interventions

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

Group III: PlaceboPlacebo Group2 Interventions

SC administration of matching placebo for 52 weeks