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NCT06932263ClinicalTrials.gov

Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

المرحلة 2مطلوب 540 مشاركاً221 موقعاً21 دولة

الفئات

الجهاز التنفسي75%المناعة والروماتيزم25%

مسجَّلة في سجل واحد

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered after enrolment began (about 22 days after the recorded start)First posted 2025-04-17; recorded start 2025-03-26
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 221 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration3/5

    Registered within 30 days of the study start

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 540 participants (target), run at 221 sites, across 21 countries.

How this score is built
  • Enrolment27/40

    540 participants (target)

  • Site count25/25

    221 sites

  • Country count15/15

    21 countries

  • Planned duration8/10

    Planned over about 36 months

  • Sponsor scale10/10

    AstraZeneca has led 991 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

ملخص

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

الحالات

  • Asthma

الأهلية

الجنسالجميع
الأعمار18 Years – 75 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study-specific procedures. 2. Adults aged 18-75, inclusive when signing the informed consent. 3. Documented physician-diagnosis of asthma for at least 12 months. 4. Treated with medium or high dose ICS in combination with LABA. 5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 . 6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal. 7. Documented exacerbation history in the last 12 months and biomarker requirements of: 1. 2 severe exacerbations OR 2. 1 severe exacerbation and: (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb 8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary. 9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test. 10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: 1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1. 2. Clinically significant pulmonary disease other than asthma . 3. Current smokers, former smokers with \>10 pack-years history. 4. Clinically significant aortic stenosis or pulmonary arterial hypertension. 5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease. 6. Unstable cardiovascular disorders.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 2
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 540 مشاركاً

الجهة الراعية والمتعاونون

  • AstraZeneca الجهة الراعية

الأذرع والتدخلات

  • Tozorakimab Dose 1EXPERIMENTAL

    Dosing subcutaneously tozorakimab Dose 1

  • Tozorakimab Dose 2EXPERIMENTAL

    Dosing subcutaneously tozorakimab Dose 2 and placebo

  • PlaceboPLACEBO_COMPARATOR

    Dosing subcutaneously with equivalent volume to tozorakimab

التدخلات

  • دواء Placebo

    Placebo will be administered subcutaneously.

  • دواء Tozorakimab

    The drug will be administered subcutaneously.

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Annualised rate of severe asthma exacerbations

    The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and ≥ 1 severe exacerbation within 12 months prior to screening.

    الإطار الزمني Over 26 to 52 weeks

  2. مقياس النتيجة الثانوي

    Annualised rate of severe asthma exacerbations

    The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and baseline eosinophils \< 300 cells/µL and history of ≥2 severe exacerbations within 12 months prior to screening.

    الإطار الزمني Over 26 to 52 weeks

  3. مقياس النتيجة الثانوي

    Time to first severe asthma exacerbation

    To evaluate the effect of two dose levels of tozorakimab compared to placebo on time to first severe asthma exacerbations.

    الإطار الزمني Over 26 to 52 weeks

  4. مقياس النتيجة الثانوي

    Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

    Difference in mean change from baseline between tozorakimab and placebo.

    الإطار الزمني Over weeks 20 to 26

  5. مقياس النتيجة الثانوي

    Change from baseline in post-bronchodilator FEV1

    Difference in mean change from baseline between tozorakimab and placebo.

    الإطار الزمني At week 26

  6. مقياس النتيجة الثانوي

    Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6)

    Difference in mean change from baseline between tozorakimab and placebo. The ACQ-6 has 6 questions (regarding asthma symptoms and rescue bronchodilator use). Answering the questions results in a score out of 6. A Score of 0 indicates complete control and 6 reflects severely uncontrolled disease.

    الإطار الزمني At week 26

  7. مقياس النتيجة الثانوي

    Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ12+)

    Difference in mean change from baseline between tozorakimab and placebo. The AQLQ12+ includes 32 questions grouped into four domains: symptoms; activity limitations; emotional function; and, environmental stimuli. Each question is scored on a seven-point Likert scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions, and the four domain scores are the means of the scores for the questions in the respective domains.

    الإطار الزمني At week 26

  8. مقياس النتيجة الثانوي

    Trough serum concentrations of tozorakimab

    Pharmacokinetics: concentrations of tozorakimab in trough serum.

    الإطار الزمني Over 52 weeks

  9. مقياس النتيجة الثانوي

    Anti-drug antibody incidence

    Immunogenicity: Number of Participants With Positive Antibodies to tozorakimab

    الإطار الزمني Over 52 weeks

التواريخ

تاريخ البدء26 مارس 2025 (فعلي)
الإتمام الأولي7 يونيو 2027 (تقديري)
الإتمام28 فبراير 2028 (تقديري)
أول نشر17 أبريل 2025 (فعلي)
آخر تحديث20 يوليو 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيوليو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

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Argentina

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Brazil

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Chile

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China

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France

المنشأةالمدينةالولاية أو المنطقةالحالة
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Greece

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يُدرَج 171 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06932263