Tezepelumab CRSwNP Real World Study (CREW Study)

N/ANot Yet RecruitingNCT07790198

AstraZeneca100 enrolled

Overview

The CREW Study is a non-interventional prospective, observational study in patients with CRSwNP that will evaluate patient-reported outcomes and describe the proportion of participants achieving treatment goals.)

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

TezepelumabDRUG

Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must be 18 years of age or older, at the time of signing the informed consent * Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1 * Participants who will be enrolled after index date need to have at least SNOT-22 prior (maximum of 4 weeks) to index date * Documented SNOT-22 total score\>=30, collected within the 4 weeks prior to the first tezepelumab dose (index date) * Treated per the Japanese Handbook for the Management of Chronic Rhinosinusitis with Nasal Polyps for at least 30 days prior to routine care visit 1 * Physician decision that participant is eligible for treatment with tezepelumab according to local approved CRSwNP label and Optimal Clinical Use Guidelines * Patients must be able and willing to read and comprehend written instructions, to collect PROs and medication intake and to sign the informed consent document Exclusion Criteria: * Patients who participate in an interventional clinical trial in the last 4 months * Known hypersensitivity to tezepelumab or any of its excipients * Patients who have received any biologic therapy for asthma or CRSwNP * Condition (acute or chronic) that, in the investigator's opinion, would limit the participant´s ability to complete questionnaires or participate in this study * Pregnancy or lactation period or planning pregnancy during the study period

Outcomes

Primary Outcomes

Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score

To describe the changes in participant-reported sinonasal symptoms as evaluated by sinonasal outcome test, 22 item (SNOT-22) total score.

Time frame: at 24 weeks from initiation of tezepelumab treatment.

Secondary Outcomes

Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score

To describe the changes in participant-reported sinonasal symptoms as SNOT-22 total score following initiation of tezepelumab treatment.

Time frame: at 4, 12, and 52 weeks from initiation of tezepelumab treatment

Proportion of tezepelumab SNOT-22 responders

Proportion of responders in sinonasal symptoms as evaluated by SNOT-22 total score, defined as patients achieving the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.

Time frame: up to 52 weeks

Odds to achieve tezepelumab SNOT-22 response

Odds to achieve tezepelumab SNOT-22 response meeting or exceeding the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.

Time frame: up to 52 weeks

Median time to first MCID-defined responder in sinonasal symptoms

To describe time to response in sinonasal symptoms as evaluated by SNOT-22 total score (time from baseline to the first occurrence of ≥ 8.9-point decrease).

Time frame: up to 52 weeks

Mean change from baseline in nasal blockage (NB) measured by VAS-NB

To describe changes in nasal blockage (NB) as evaluated by a visual analogue scale (VAS-NB) at each collected timepoint.

Time frame: up to 52 weeks

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

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Proportion of NB responders

To describe proportion of NB responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline; in participants with VAS-NB ≥ 7 at baseline) at each collected timepoint.

Time frame: up to 52 weeks

Median time to meeting or exceeding the MCID for VAS-NB

Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-NB ≥ 7 at baseline.

Time frame: up to 52 weeks

Mean change from baseline in sense of smell score by VAS-smell

To describe changes in sense of smell as evaluated by VAS-Smell

Time frame: up to 52 weeks

Proportion of VAS-Smell responders

Proportion of VAS-Smell responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline) in participants with VAS-Smell ≥ 7 at baseline at each collected timepoint.

Time frame: up to 52 weeks

Median time to meeting or exceeding the MCID for VAS-Smell

Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-Smell ≥ 7 at baseline.

Time frame: up to 52 weeks

Mean change from baseline in NP severity as measured by VAS-NP symptoms

To describe changes in NP severity (VAS-NP) at each collected timepoint.

Time frame: up to 52 weeks

Proportion of VAS-NP symptom responders

To describe responders proportion of VAS-NP symptom responders, defined as patients achieving the MCID (≥ 2.5-point decrease from baseline) at each collected timepoint.

Time frame: up to 52 weeks

Median time to meeting or exceeding the MCID for VAS-NP symptom

Median time from baseline to the first occurrence of a ≥2.5-point decrease by each collected timepoint.

Time frame: up to 52 weeks

Mean change from baseline in total NPS evaluated by nasal endoscopy

To describe changes in nasal polyp score (NPS) at each collected timepoint.

Time frame: up to 52 weeks

Proportion of NPS responders

To describe proportion of NPS responders, defined as patients achieving the MCID (≥ 1.0-point decrease from baseline).

Time frame: up to 52 weeks

Median time to meeting or exceeding the MCID for NPS

To describe median time to meeting or exceeding the MCID for NPS by each collected timepoint.

Time frame: up to 52 weeks

Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question

To describe responder proportion for NP control.

Time frame: up to 52 weeks

Median time to first attainment of NP well control or NP complete control

To describe median time to first attainment of NP well control or NP complete control by each collected timepoint.

Time frame: up to 52 weeks

Average SCS daily dose after initiating tezepelumab

To describe overall systemic steroid use in participants, measured as average SCS daily dose (e.g., prednisone-equivalent milligrams).

Time frame: From baseline up to 24 weeks and from baseline up to 52 weeks

Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use

To describe proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use.

Time frame: From baseline up to 24 weeks and from baseline up to 52 weeks

Number of patients with ≥ 100, 200 and 400 mg cumulative SCS

Number of patients with ≥ 100, 200 and 400 mg cumulative SCS (e.g., prednisone-equivalent milligrams).

Time frame: From baseline up to 24 weeks and from baseline up to 52 weeks

Time-to-first disease-related SCS use

Time-to-first disease-related SCS use, with cumulative incidence CRSwNP-related SCS use, asthma-related SCS use, other indications related SCS use and unknown indication-related SCS use.

Time frame: From baseline up to 24 weeks and from baseline up to 52 weeks

Proportion of participants with AEs, SAEs, DAEs, and AESIs

To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.

Time frame: Up to 52 weeks

Individual goal attainment

Proportion of participants achieving symptoms goal: SNOT-22\* ≤ 20