Itepekimab for Chronic Sinusitis with Nasal Polyps

(CEREN2 Trial)

Recruiting at 121 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of itepekimab, an experimental treatment, for people with chronic sinusitis and nasal polyps. The study will compare two different doses of itepekimab with a placebo to determine which is most effective alongside regular nasal spray treatments. It seeks participants who have experienced ongoing sinus issues and nasal polyps for at least one year and have required surgery or special medications to manage symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you've used certain nasal sprays or systemic corticosteroids recently. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that itepekimab was tested in earlier studies to assess its safety for people. In some studies, itepekimab was compared to a placebo, a harmless substance, to identify any side effects. These studies also evaluated how well participants tolerated the treatment. Results so far indicate that itepekimab is generally well-tolerated, with most participants not experiencing serious problems.

As this is a Phase 3 study, researchers continue to gather more information about its safety. This phase confirms results from earlier studies and involves a larger group to ensure the treatment's safety for everyone. Although itepekimab has shown promise, ongoing studies will monitor for any unwanted side effects to ensure the treatment remains safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for chronic sinusitis with nasal polyps, like corticosteroids and surgery, focus on reducing inflammation or physically removing the polyps. But Itepekimab works differently by targeting and blocking a specific protein called interleukin-33 (IL-33), which plays a crucial role in the inflammatory process. This unique mechanism may offer a more targeted approach to reducing inflammation and symptoms. Researchers are excited because this could lead to better management of chronic sinusitis with potentially fewer side effects compared to traditional options.

What evidence suggests that this trial's treatments could be effective for chronic sinusitis with nasal polyps?

Studies have shown that itepekimab can help shrink nasal polyps and improve symptoms of chronic rhinosinusitis with nasal polyps (CRSwNP). Research indicates that this treatment blocks a specific protein responsible for inflammation, reducing swelling and congestion in the sinuses. Initial findings suggest that patients receiving itepekimab experienced noticeable improvements compared to those who received a placebo. In earlier studies, patients reported better breathing and less sinus pressure. These promising results highlight itepekimab's potential to effectively treat CRSwNP. ^{2 5 6 7 8}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06691113

NCT06691113 | A Proof-of-Concept Study to Assess the ... The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo in male and female ...

2. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//ca/en/listing/313004/a-proof-of-concept-study-to-2/

A Proof-of-Concept Study to Assess the Efficacy, Safety The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo in male and female ...

3. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-05-30-05-00-00-3090818

Press Release: Itepekimab met the primary endpoint in one ... In AERIFY-1, the overall rates of AEs were 67% and 68% for itepekimab every two weeks and every four weeks, respectively, compared to 68% for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11365161/

Exploratory pharmacodynamics and efficacy of PF ... Rhinosinusitis symptoms were improved, and nasal polyps were decreased in size following treatment with PF-06817024 in patients with CRSwNP.

5. trialx.com trialx.com/clinical-trials/listings/297512/a-phase-3-study-to-assess-the-efficacy-safety-and-tolerability-of-itepekimab-anti-il-33-mab-in-participants-with-inadequately-controlled-chronic-rhinosinusitis-with-nasal-polyps/

A Phase 3 Study to Assess the Efficacy, Safety, and ... 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06834347

NCT06834347 | A Phase 3 Study to Assess the Efficacy, ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12535206/

Biologics for Chronic Rhinosinusitis With Nasal Polyposis In the ANCHOR‐1 and ANCHOR‐2 phase III trials, depemokimab significantly reduced nasal polyp score and nasal obstruction compared with placebo, ...

8. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0MPr000000U8bGMAS/nct06834347

nct06834347 - Clinical Trials | Regeneron Pharmaceuticals 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 ...