CEREN-2

What is the Purpose of this Study?

Primary -To evaluate the efficacy of itepekimab compared with placebo on NP size and nasal congestion Secondary - To evaluate the long-term efficacy of itepekimab compared with placebo on NP size. - To evaluate the long-term efficacy of itepekimab compared to placebo on nasal congestion. - To evaluate the efficacy of itepekimab compared with placebo on sinus opacification. - To evaluate the efficacy of itepekimab compared to placebo on symptoms of CRSwNP. - To evaluate the efficacy of itepekimab compared to placebo on sense of smell. - To evaluate the efficacy of itepekimab compared to placebo on health-related quality of life. - To evaluate the efficacy of itepekimab compared to placebo on sleep disturbance. - To evaluate the ability of itepekimab compared to placebo to reduce the risk of worsening/acute sinusitis requiring treatment with SCS or sinus surgery. - To evaluate the effect of itepekimab compared to placebo on asthma in the subgroup of participants with comorbid asthma. - To evaluate the effect of itepekimab compared to placebo in the subgroup of participants with AERD. - To evaluate the efficacy of itepekimab compared to placebo. - To evaluate the safety and tolerability of itepekimab compared to placebo in participants with CRSwNP. - To evaluate the PK of itepekimab. - Assessment of immunogenicity to itepekimab over time compared to placebo.


Eligibility

  • * Participants must be 18 years of age or older.
  • * Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening
  • * Participants must have at least one of the following features:
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A randomized, double-blind, placebo-controlled, parallel-group, 52-week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps

Study Details
Disease Type/Condition

Other

Principal Investigator

Wu, Arthur

Age Group

Adult

Phase

III

IRB Number

STUDY00003911

ClinicalTrials.gov ID

NCT06834360

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Wu, Arthur

Age Group

Adult

Phase

III

IRB Number

EFC18419

ClinicalTrials.gov ID

NCT06834360

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org