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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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.

שלב 2דרושים 540 משתתפים221 אתרים21 מדינות

קטגוריות

מערכת הנשימה75%אימונולוגיה וראומטולוגיה25%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

  • Asthma

זכאות

מיןהכול
גילאים18 Years – 75 Years
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 2
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהQUADRUPLE (4)
גיוסדרושים 540 משתתפים

נותן חסות ושותפים

  • AstraZeneca נותן חסות

זרועות והתערבויות

  • 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

התערבויות

  • תרופה Placebo

    Placebo will be administered subcutaneously.

  • תרופה Tozorakimab

    The drug will be administered subcutaneously.

מדדי תוצאה

  1. מדד תוצאה ראשוני

    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.

    מסגרת זמן Over 26 to 52 weeks

  2. מדד תוצאה משני

    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.

    מסגרת זמן Over 26 to 52 weeks

  3. מדד תוצאה משני

    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.

    מסגרת זמן Over 26 to 52 weeks

  4. מדד תוצאה משני

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

    Difference in mean change from baseline between tozorakimab and placebo.

    מסגרת זמן Over weeks 20 to 26

  5. מדד תוצאה משני

    Change from baseline in post-bronchodilator FEV1

    Difference in mean change from baseline between tozorakimab and placebo.

    מסגרת זמן At week 26

  6. מדד תוצאה משני

    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.

    מסגרת זמן At week 26

  7. מדד תוצאה משני

    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.

    מסגרת זמן At week 26

  8. מדד תוצאה משני

    Trough serum concentrations of tozorakimab

    Pharmacokinetics: concentrations of tozorakimab in trough serum.

    מסגרת זמן Over 52 weeks

  9. מדד תוצאה משני

    Anti-drug antibody incidence

    Immunogenicity: Number of Participants With Positive Antibodies to tozorakimab

    מסגרת זמן Over 52 weeks

תאריכים

תאריך התחלה26 במרץ 2025 (בפועל)
סיום ראשוני7 ביוני 2027 (משוער)
סיום28 בפברואר 2028 (משוער)
פורסם לראשונה17 באפריל 2025 (בפועל)
עודכן לאחרונה20 ביולי 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהיולי 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

150 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Research SiteCABAמגייס
Research SiteCiudad de Buenos Airesבוטל
Research SiteCiudad de Buenos Airesמגייס
Research SiteLa Plataמגייס
Research SiteMendozaמגייס
Research SiteRosarioמגייס
Research SiteSan Miguel de Tucumánמגייס

Brazil

מתקןעירמדינה או אזורמצב
Research SiteCaxias do Sulבוטל
Research SiteCriciúmaמגייס
Research SitePorto Alegreמגייס
Research SitePorto Alegreמגייס
Research SiteSalvadorבוטל
Research SiteSanto Andréבוטל
Research SiteSorocabaמגייס
Research SiteSão José do Rio Pretoמגייס
Research SiteSão Pauloמגייס
Research SiteSão Pauloמגייס

Chile

מתקןעירמדינה או אזורמצב
Research SiteCuricóפעיל, ללא גיוס
Research SiteQuillotaפעיל, ללא גיוס
Research SiteSantiagoפעיל, ללא גיוס
Research SiteSantiagoפעיל, ללא גיוס
Research SiteSantiagoפעיל, ללא גיוס
Research SiteTemucoפעיל, ללא גיוס
Research SiteViña del Marפעיל, ללא גיוס

China

מתקןעירמדינה או אזורמצב
Research SiteBaotouמגייס
Research SiteChangchunמגייס
Research SiteChengduמגייס
Research SiteChongqingמגייס
Research SiteGuangzhouמגייס
Research SiteHaikouמגייס
Research SiteHefeiמגייס
Research SiteHohhotמגייס
Research SiteHuizhouמגייס
Research SiteQingdaoמגייס
Research SiteShanghaiמגייס
Research SiteShanghaiמגייס
Research SiteShanghaiמגייס
Research SiteShenzhenמגייס
Research SiteWenzhouמגייס
Research SiteXuzhouמגייס

France

מתקןעירמדינה או אזורמצב
Research SiteBrestמגייס
Research SiteCréteilמגייס
Research SiteLyonמגייס
Research SiteMarseilleמגייס
Research SitePessacמגייס
Research SiteStrasbourgמגייס
Research SiteSuresnesמגייס

Greece

מתקןעירמדינה או אזורמצב
Research SiteAthensמגייס
Research SiteAthensמגייס
Research SiteIoanninaבוטל

171 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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