deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT03614923

Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

A Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Investigate Etokimab (ANB020) in Adult Subjects With Chronic Rhinosinusitis With Nasal Polyposis

Sponsor: AnaptysBio, Inc.

Updated 12 times since 2018 Last updated: Jan 20, 2022 Started: Nov 29, 2018 Primary completion: Sep 2, 2020 Completion: Oct 26, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Chronic Rhinosinusitis, this trial is completed. The trial is conducted by AnaptysBio, Inc. and has accumulated 12 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

This study is a randomized, placebo controlled, double-blind, multi-dose study to assess the efficacy of two different dose regimens of etokimab compared to placebo in adults with moderate-to-severe chronic sinusitis with nasal polyposis (CRSwNP). During the screening period, all subjects will undergo evaluation for eligibility. A centralized reader will be used to confirm the diagnosis of CRSwNP as assessed by nasal endoscopy, computed tomography (CT) scan of sinuses, and symptom scoring to reduce the risk of interpretation variation. Participants will also be provided mometasone furoate nasal spray (MFNS) for use during the trial and are required to undergo a minimum run-in period of 20 days prior to Day 1 with approximately 80% compliance. Participants will be randomly assigned on Day 1 to one of the three treatment arms in a 1:1:1 ratio.

This study is a randomized, placebo controlled, double-blind, multi-dose study to assess the efficacy of two different dose regimens of etokimab compared to placebo in adults with moderate-to-severe chronic sinusitis with nasal polyposis (CRSwNP).

During the screening period, all subjects will undergo evaluation for eligibility. A centralized reader will be used to confirm the diagnosis of CRSwNP as assessed by nasal endoscopy, computed tomography (CT) scan of sinuses, and symptom scoring to reduce the risk of interpretation variation.

Participants will also be provided mometasone furoate nasal spray (MFNS) for use during the trial and are required to undergo a minimum run-in period of 20 days prior to Day 1 with approximately 80% compliance.

Participants will be randomly assigned on Day 1 to one of the three treatment arms in a 1:1:1 ratio.

Status Flow

~Sep 2018 – ~Mar 2019 · 6 months · monthly snapshotNot Yet Recruiting~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshotRecruiting~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshotRecruiting~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshotRecruiting~Aug 2019 – ~Jun 2020 · 10 months · monthly snapshotRecruiting~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotActive Not Recruiting~Feb 2021 – ~Feb 2022 · 12 months · monthly snapshotCompleted~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Feb 2022 — Jul 2024 [monthly]

    Completed PHASE2

  5. Feb 2021 — Feb 2022 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

Show 7 earlier versions
  1. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE2

  2. Jun 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  3. Aug 2019 — Jun 2020 [monthly]

    Recruiting PHASE2

  4. Jun 2019 — Aug 2019 [monthly]

    Recruiting PHASE2

  5. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE2

  6. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  7. Sep 2018 — Mar 2019 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AnaptysBio, Inc.
Data source: AnaptysBio, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .