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Bestimmen Sie die Wirksamkeit von Anifrolumab bei SYstemischer Sklerose (DAISY) (DAISY)

29. September 2026 aktualisiert von: AstraZeneca

Eine multizentrische, randomisierte, doppelblinde, zweiarmige Parallelgruppenstudie der Phase III zur Bewertung der Sicherheit und Wirksamkeit von Anifrolumab im Vergleich zu Placebo bei männlichen und weiblichen Teilnehmern im Alter von 18 bis einschließlich 70 Jahren mit systemischer Sklerose

The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study to evaluate the efficacy and safety of anifrolumab in the treatment of adult participants with Systemic Sclerosis (SSc) who may be taking one or a combination of protocol-specified standard therapies. The use of one of the following standard immunosuppressant therapies is permitted at a stable dose, but not mandated: hydroxychloroquine, mycophenolate mofetil (MMF), mycophenolic acid or mycophenolate sodium (MPA/MPS), methotrexate, azathioprine, tacrolimus, and oral glucocorticoids. MMF or MPA/MPS, azathioprine, and methotrexate may be used in combination with hydroxychloroquine and/or low-dose oral glucocorticoids [≤ 10 mg/day].

Approximately 306 eligible participants will be randomized in a 1:1 ratio to receive either anifrolumab (or matching placebo) given subcutaneously once weekly for 52 weeks. The study will be stratified by the following factors:

  • Interstitial lung disease (ILD) (yes, no) at Week 0 (Day1);
  • MMF or MPA/MPS use (yes ,no) at Week 0 (Day 1); and
  • Disease duration, defined as the time from the first non-Raynaud's symptom attributable to SSc (<18 months, ≥ 18 months) at Week 0 (Day 1)

Study treatment will be administered subcutaneously via an accessorized prefilled syringe by study staff or by the participant or carer, either in the clinic or at home, with most doses being administered at home. The study consists of 4 periods: a 6-week screening period, a 52-week, double-blind, placebo-controlled period, a 52-week open-label active treatment period, and a 12-week safety follow-up period. There are a total of 16 study visits with most visits in the treatment period occurring every 8 to 12 weeks. The periods are described below:

  • Screening Period: This may involve one or more visits to the study site.
  • Double Blind Treatment Period: Treatment Period when participants will receive once weekly injections of anifrolumab or matching placebo. Participation will involve in-clinic study visits at Weeks 0 (Day 1), 1, 4, 8*, 16, 24, 36, 48 and 52. *The visit at Week 8 may be either by telephone or in person.
  • Open Label Treatment Period: At Week 52, all participants will be given anifrolumab (subcutaneous) once weekly for 52 weeks (last dose at Week 103). Participation will involve in-clinic study visits at Weeks 52, 53*, 56, 64, 76. 88 and 104. *The visit at Week 53 may be either by telephone or in person.
  • Safety Follow-up Period: All participants will return to the clinic for a 12-week post treatment visit. This will occur post Double Blind Treatment Period (Week 52 or Double Blind Period early discontinuation) or post Open Label Treatment Period (Week 104 or Open Label Period early discontinuation).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

314

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Ghent, Belgien, B-9000
        • Research Site
      • Leuven, Belgien, 3000
        • Research Site
  • China
      • Beijing, China, 100191
        • Research Site
      • Beijing, China, CN-100730
        • Research Site
      • Guangzhou, China, 510100
        • Research Site
      • Guangzhou, China, 510530
        • Research Site
      • Hangzhou, China, 310014
        • Research Site
      • Lanzhou, China, 730000
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 201210
        • Research Site
      • Tianjin, China, 300050
        • Research Site
  • Deutschland
      • Freiburg im Breisgau, Deutschland, 79106
        • Research Site
      • Mainz, Deutschland, 55131
        • Research Site
      • Minden, Deutschland, 32429
        • Research Site
      • Münster, Deutschland, 48149
        • Research Site
      • Tübingen, Deutschland, 72076
        • Research Site
  • Frankreich
      • Bordeaux, Frankreich, 33076
        • Research Site
      • Brest, Frankreich, 29609
        • Research Site
      • Paris, Frankreich, 75020
        • Research Site
      • Paris, Frankreich, 75679
        • Research Site
      • Rennes, Frankreich, 35033
        • Research Site
      • Strasbourg, Frankreich, 67098
        • Research Site
      • Toulouse, Frankreich, 31059
        • Research Site
  • Indien
      • Ahmedabad, Indien, 380006
        • Research Site
      • Delhi, Indien, 110060
        • Research Site
      • Gurugram, Indien, 122001
        • Research Site
      • Hyderabad, Indien, 500082
        • Research Site
      • Kolkata, Indien, 700020
        • Research Site
      • Mumbai, Indien, 400053
        • Research Site
      • Mysuru, Indien, 570004
        • Research Site
      • New Delhi, Indien, 11029
        • Research Site
      • Pune, Indien, 411001
        • Research Site
      • Secunderabad, Indien, 500003
        • Research Site
  • Israel
      • Afula, Israel, 18101
        • Research Site
      • Haifa, Israel, 31096
        • Research Site
      • Haifa, Israel, 31048
        • Research Site
      • Jerusalem, Israel, 00000
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Research Site
      • Ramat Gan, Israel, 52621
        • Research Site
  • Italien
      • Ancona, Italien, 60126
        • Research Site
      • Brescia, Italien, 25123
        • Research Site
      • Cona, Italien, 44124
        • Research Site
      • Milan, Italien, 20122
        • Research Site
      • Padova, Italien, 35128
        • Research Site
      • Roma, Italien, 00168
        • Research Site
      • Roma, Italien, 00128
        • Research Site
      • Roma, Italien, 161
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8603
        • Research Site
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Iruma-Gun, Japan, 350-0495
        • Research Site
      • Kanazawa, Japan, 920-8641
        • Research Site
      • Maebashi, Japan, 371-8511
        • Research Site
      • Nagasaki, Japan, 852-8501
        • Research Site
      • Nagoya, Japan, 457-0866
        • Research Site
      • Sapporo, Japan, 060-8638
        • Research Site
      • Sendai, Japan, 980-8574
        • Research Site
      • Shinjuku-ku, Japan, 160-8582
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Research Site
      • Takatsuki-shi, Japan, 569-8686
        • Research Site
      • Toyoake-shi, Japan, 470-1192
        • Research Site
      • Yokohama, Japan, 236-0004
        • Research Site
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4Z6
        • Research Site
    • Ontario
      • Toronto, Ontario, Kanada, M5T 3L9
        • Research Site
    • Quebec
      • Montreal, Quebec, Kanada, H4J 1C5
        • Research Site
      • Montreal, Quebec, Kanada, H3T 1E2
        • Research Site
      • Québec, Quebec, Kanada, G1V 4K5
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Kuching, Malaysia, 93586
        • Research Site
      • Seremban, Malaysia, 70300
        • Research Site
  • Mexiko
      • Chihuahua City, Mexiko, 31000
        • Research Site
      • Guadalajara, Mexiko, 44650
        • Research Site
      • Guadalajara, Mexiko, 44158
        • Research Site
      • Mexico City, Mexiko, 06700
        • Research Site
      • San Luis Potosí City, Mexiko, 78250
        • Research Site
      • San Luis Potosí City, Mexiko, 78213
        • Research Site
  • Niederlande
      • Groningen, Niederlande, 9713 GZ
        • Research Site
  • Polen
      • Bydgoszcz, Polen, 85-168
        • Research Site
      • Krakow, Polen, 30-002
        • Research Site
      • Krakow, Polen, 30-105
        • Research Site
      • Lodz, Polen, 90-549
        • Research Site
      • Sosnowiec, Polen, 41-200
        • Research Site
      • Warsaw, Polen, 00-874
        • Research Site
  • Rumänien
      • Bucharest, Rumänien, 011172
        • Research Site
      • Bucharest, Rumänien, 020475
        • Research Site
      • Cluj-Napoca, Rumänien, 400006
        • Research Site
      • Iași, Rumänien, 700661
        • Research Site
  • Spanien
      • A Coruña, Spanien, 15006
        • Research Site
      • Barcelona, Spanien, 08041
        • Research Site
      • Barcelona, Spanien, 08003
        • Research Site
      • Madrid, Spanien, 28041
        • Research Site
      • Málaga, Spanien, 29009
        • Research Site
      • Valencia, Spanien, 46026
        • Research Site
      • Valencia, Spanien, 46017
        • Research Site
  • Südafrika
      • Parktown, Südafrika, 2193
        • Research Site
      • Pretoria, Südafrika, 0083
        • Research Site
  • Südkorea
      • Busan, Südkorea, 49241
        • Research Site
      • Seoul, Südkorea, 03080
        • Research Site
      • Seoul, Südkorea, 04763
        • Research Site
      • Seoul, Südkorea, 04401
        • Research Site
      • Seoul, Südkorea, 137-701
        • Research Site
  • Türkei (türkiye)
      • Ankara, Türkei (türkiye), 06100
        • Research Site
      • Ankara, Türkei (türkiye), 06230
        • Research Site
      • Antalya, Türkei (türkiye), 07059
        • Research Site
      • Center, Türkei (türkiye), 23200
        • Research Site
      • Kazımkarabekir, Türkei (türkiye), 01230
        • Research Site
      • Kocaeli, Türkei (türkiye), 41380
        • Research Site
  • Ungarn
      • Budapest, Ungarn, 1027
        • Research Site
      • Budapest, Ungarn, 1023
        • Research Site
      • Budapest, Ungarn, 1138
        • Research Site
      • Debrecen, Ungarn, 4032
        • Research Site
      • Pécs, Ungarn, 7632
        • Research Site
      • Szeged, Ungarn, 6725
        • Research Site
  • Vereinigte Staaten
    • Arizona
      • Scottsdale, Arizona, Vereinigte Staaten, 85259
        • Research Site
    • California
      • Chula Vista, California, Vereinigte Staaten, 91910
        • Research Site
      • Los Angeles, California, Vereinigte Staaten, 90095
        • Research Site
      • Orange, California, Vereinigte Staaten, 92868
        • Research Site
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • Research Site
    • Connecticut
      • New Haven, Connecticut, Vereinigte Staaten, 06519
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20007
        • Research Site
    • Florida
      • Boca Raton, Florida, Vereinigte Staaten, 33486
        • Research Site
      • Fort Lauderdale, Florida, Vereinigte Staaten, 33309
        • Research Site
      • Gainesville, Florida, Vereinigte Staaten, 32603
        • Research Site
      • Jacksonville, Florida, Vereinigte Staaten, 32216
        • Research Site
      • Margate, Florida, Vereinigte Staaten, 33063
        • Research Site
      • South Miami, Florida, Vereinigte Staaten, 33143
        • Research Site
      • Tamarac, Florida, Vereinigte Staaten, 33321
        • Research Site
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Research Site
    • Kansas
      • Kansas City, Kansas, Vereinigte Staaten, 66160
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70121
        • Research Site
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21224
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • Research Site
    • Minnesota
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Research Site
    • New York
      • Babylon, New York, Vereinigte Staaten, 11702
        • Research Site
      • New York, New York, Vereinigte Staaten, 10032
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45219
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • Research Site
    • Texas
      • Allen, Texas, Vereinigte Staaten, 75013
        • Research Site
      • Houston, Texas, Vereinigte Staaten, 77030
        • Research Site
  • Vereinigtes Königreich
      • Cannock, Vereinigtes Königreich, WS11 2XY
        • Research Site
      • Leeds, Vereinigtes Königreich, LS7 4SA
        • Research Site
      • London, Vereinigtes Königreich, NW3 2QG
        • Research Site
      • Sheffield, Vereinigtes Königreich, S10 2JF
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 10000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site
      • Ho Chi Minh City, Vietnam, 70000
        • Research Site
      • Hochiminh, Vietnam, 70000
        • Research Site
      • Hà Nội, Vietnam, 100000
        • Research Site
  • Österreich
      • Graz, Österreich, 8036
        • Research Site
      • Innsbruck, Österreich, 6020
        • Research Site
      • Vienna, Österreich, 1090
        • Research Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Key Inclusion Criteria:

  1. Adult patients from 18 to 70 years of age inclusive
  2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria
  3. Limited or diffuse cutaneous subsets
  4. Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
  5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
  6. mRSS > 10 with early disease or rapid progression as defined by the protocol
  7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
  8. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
  9. Women of childbearing potential with a negative urine pregnancy test
  10. Uninvolved skin at injection sites

Key Exclusion Criteria:

  1. Anticentromere antibody seropositivity on central laboratory
  2. Severe cardiopulmonary disease as defined by the protocol
  3. History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) < 45 mL/min/1.73m2)
  4. Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis)
  5. History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy
  6. Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease [Child Pugh A, B, C hepatic impairment]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator
  7. Hematopoietic stem cell transplantation or solid organ/limb transplantation
  8. Any severe case of Herpes Zoster infection as defined by the protocol
  9. Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
  10. Major surgery within 8 weeks prior to and/or during study enrollment
  11. Known active current or history of recurrent infections
  12. Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Anifrolumab (subcutaneous weekly injection)

Anifrolumab subcutaneous injection once weekly
Kombinationsprodukt: Anifrolumab (blinded)

Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

Andere Namen:
  • Behandlungsarm (verblindet)
Kombinationsprodukt: Anifrolumab (unblinded, open label)

At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks

Andere Namen:
  • Behandlungsarm (nicht verblindet)
Placebo-Komparator: matched placebo control (subcutaneous weekly injection)

matched placebo control subcutaneous injection once weekly
Arzneimittel: Placebo (blinded)

matched placebo delivered subcutaneously, once weekly for 52 weeks

Andere Namen:
  • Placebo-Arm (verblindet)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Zeitfenster: at Week 52

Number of participants meeting all the criteria:

  • Improvement in at least 2 components (≥5% increase for percent predicted Forced Vital Capacity (FVC) and/or≥25% decrease for Modified Rodnan Skin Score (mRSS), Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment (PtGA), Clinician Global Assessment (CGA)
  • Worsening in no more than one component (≥5% decrease percent predicted FVC and/or≥25% increase for mRSS, HAQ-DI, PtGA, CGA)
  • No significant SSc-related event as defined by:

New scleroderma renal crisis New decline in percent predicted FVC≥15% in established interstitial lung disease or new percent predicted FVC below 80% predicted New onset of left ventricular failure requiring treatment New onset of pulmonary arterial hypertension requiring treatment Gastrointestinal dysmotility requiring enteral or parenteral nutrition Digital ischemia with gangrene, amputation, or hospitalization requiring treatment

-Otherwise, a participant is a non-responder
at Week 52

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in mRSS
Zeitfenster: at Week 52

Change from baseline in mRSS score. The mRSS scoring ranges from 0 (normal) to 51 (severe).
at Week 52
Number of patients with improvement in individual revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Zeitfenster: at Week 52

Number of participants who have improvements in the following improvement components, evaluated separately:

  • ≥ 5% increase in percent predicted Forced Vital Capacity (FVC)
  • ≥ 25% decrease in mRSS
  • ≥ 25% decrease in HAQ-DI
  • ≥25% decrease in PtGA
  • ≥25% decrease in CGA
at Week 52
Change from baseline in chest computed tomography imaging
Zeitfenster: at Week 52

Change from baseline in quantitative interstitial lung disease score
at Week 52
Change from baseline in Scleroderma Skin Patient Reported Outcome
Zeitfenster: at Week 52

Change from baseline in the Scleroderma Skin Patient Reported Outcome scores
at Week 52
Change from baseline in FVC
Zeitfenster: at Week 52
  1. Change from baseline in FVC (ml) in patients with interstitial lung disease
  2. Change from baseline in FVC (ml) in all patients
at Week 52
Change from baseline in percent predicted FVC
Zeitfenster: at Week 52
  1. Change from baseline in percent predicted FVC in patients with interstitial lung disease
  2. Change from baseline in percent predicted FVC in all patient
at Week 52
Anifrolumab pharmacokinetic parameters in serum
Zeitfenster: Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)

Anifrolumab serum concentrations will be summarised using descriptive statistics at each visit. Due to sparse pharmacokinetic sampling, the pharmacokinetic assessment will be primarily based on observed serum trough concentrations (Ctrough)
Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
Anifrolumab pharmacodynamics via changes in type I IFN 21-gene signature generated from blood
Zeitfenster: Double-blind treatment period: pre-dose (Day 1) Weeks 4, 16, 24, 52; open-label period: weeks 56, 76 and 104

Type I Interferon inducible gene signature will be assessed by a 21-gene assay in whole blood. The suppression of the type I IFN 21-gene signature will be showed as a percent of baseline through study completion, during both the double-blind treatment and open label periods.
Double-blind treatment period: pre-dose (Day 1) Weeks 4, 16, 24, 52; open-label period: weeks 56, 76 and 104
Prevalence of anti-drug antibodies to Anifrolumab
Zeitfenster: Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)

Anti-drug antibodies and titer determination in anti-drug antibody positive participants. The presence of neutralizing anti-drug antibodies will also be tested in all anti-drug positive samples.
Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
Incidence of adverse events
Zeitfenster: From screening to follow-up (max 126 weeks)

Adverse events (non-serious, serious, and adverse event of special interest (AESI)) are assessed as variables of safety and tolerability of anifrolumab.

The AESIs are non-opportunistic serious infections, opportunistic infections, malignancy, herpes zoster, Tuberculosis (TB) (including latent TB), injection site reactions, and major adverse cardiac events.
From screening to follow-up (max 126 weeks)
Incidence of abnormal vital signs
Zeitfenster: From screening to follow-up (max 126 weeks)

Change from baseline of pulse rate, blood pressure, respiration rate, and body temperature will be assessed by visit and treatment group including participants with treatment-emergent changes.
From screening to follow-up (max 126 weeks)
Incidence of abnormal laboratory parameters
Zeitfenster: From screening to follow-up (max 126 weeks)

Changes from baseline in haematology, clinical chemistry and lipid variables will be assessed by visit and treatment including participants with treatment-emergent changes.
From screening to follow-up (max 126 weeks)
Incidence of abnormal ECG findings
Zeitfenster: From screening to end of treatment visit (max 110 weeks)

Observed values of heart rate, QRS duration, PR interval, RR interval and QT interval will be summarised by visit and treatment group including participants with clinically significant abnormal results.
From screening to end of treatment visit (max 110 weeks)
Incidence of abnormal physical exam findings
Zeitfenster: From screening to follow-up (max 126 weeks)

Changes from baseline in weight (kilograms) will be assessed by visit and treatment and medically significant changes from the screening physical examination will be recorded as adverse events.
From screening to follow-up (max 126 weeks)
Number of subjects with suicidal ideation and behavior and suicide attempts via Columbia-Suicide Severity Rating Scale (C-SSRS)
Zeitfenster: From screening to follow-up (max 126 weeks)

The C-SSRS is used to assess suicidal ideation, behavior, and suicide on a graded scale from 1 to 5. 1 indicates as low suicidal and 5 as high suicidal behavior.
From screening to follow-up (max 126 weeks)
Total score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Zeitfenster: From screening to follow-up (max 126 weeks)

PHQ-8 is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQD-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms.
From screening to follow-up (max 126 weeks)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AstraZeneca

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

8. November 2023

Primärer Abschluss (Geschätzt)

6. Januar 2027

Studienabschluss (Geschätzt)

5. April 2028

Studienanmeldedaten

Zuerst eingereicht

2. Juni 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2023

Zuerst gepostet (Tatsächlich)

29. Juni 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D3460C00002
  • 2023-505976-31 (Andere Kennung: EuCTR)
  • 2023 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AstraZeneca disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AstraZeneca group of companies sponsored clinical trials are accepting requests for IPD, but this does not mean all requests will be shared.

IPD-Sharing-Zeitrahmen

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. The timelines vary per request and can take up to a year upon full submission of the request for analysis, decision, anonymisation and sharing of the requested data or documents. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-Sharing-Zugriffskriterien

When a request has been approved, AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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