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Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma.

NCT06473779 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2026-03-12

No results posted yet for this study

Summary

The objective of this study is to assess the potential for tezepelumab-treated patients (subcutaneous administration) to reduce maintenance therapy without loss of asthma control in adolescent and adults with severe asthma..

Study details include:

1. The study duration will be up to 72 weeks.
2. The treatment duration will be up to 68 weeks.
3. The visit frequency will be once every 4 weeks (Q4W).

Conditions

Interventions

COMBINATION_PRODUCT

Tezepelumab

IMP. Subcutaneous injection. Unit dose strengths 210 mg.

COMBINATION_PRODUCT

Budesonide/formoterol

AxMP. Oral inhalation. High-dose: 160 μg/4.5 μg per inhalation; Medium and Low-dose: 80 μg/4.5 μg per inhalation

COMBINATION_PRODUCT

Albuterol/budesonide (AIRSUPRA®)

AxMP. Oral inhalation. Reliever only. Unit dose strengths 90 μg/80 μg per inhalation In US only.

COMBINATION_PRODUCT

Mannitol

NIMP. Oral nebulization. Unit dose strengths: Graduated doses of 0 mg, 5 mg, 10 mg, 20 mg and 40 mg capsules

COMBINATION_PRODUCT

Salbutamol

AxMP. Used outside the US only. Oral inhalation. Unit dose strengths: 100 μg per inhalation

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2027-06-25
Completion
2027-06-25
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Mexico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06473779 on ClinicalTrials.gov