Health TrialsbyHealthPanel

Tezepelumab CRSwNP Real World Study (CREW Study)

ConditionChronic Rhinosinusitis With Nasal Polyps
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

The study population will consist of male and female participants aged ≥ 18 years with diagnosed severe uncontrolled CRSwNP, for whom a tezepelumab biologic treatment for CRSWNP will be initiated. Eligible participant will be identified in routine care and enrolled prospectively at participating sites.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tezepelumab

    Drug

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Tezepelumab Treatment Group1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: