A Study to Assess the Safety, Tolerability, PK and PD of WIN378 in Participants With Moderate - Severe COPD (Sirius)
9. juni 2026 opdateret af: Windward Bio
A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of WIN378 in Participants With Moderate - Severe Chronic Obstructive Pulmonary Disease
This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD).
WIN378 blocks the action of a protein called TSLP that causes inflammation in the lung and may contribute to COPD control and symptoms.
The study will test how doses of WIN378 are handled by the body (pharmacokinetics) and assess the safety of the medicine and markers of COPD inflammation in exhaled breath and blood, lung function and COPD control (pharmacodynamics)
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, and pharmacokinetics of WIN378 in adult participants with moderate - severe chronic obstructive pulmonary disease (COPD).
Participants will continue their standard background COPD therapy.
Eligible participants will receive doses of WIN378 or placebo over a 24-week treatment period.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
105
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Juliana Hutchinson, MSc
- Telefonnummer: +4161 551 75 75
- E-mail: clinical.trial.enquiry@windwardbio.com
Studiesteder
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Florida
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Miami Lakes, Florida, Forenede Stater, 33014
- Rekruttering
- WB Contracted Clinical Research Site
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28277
- Rekruttering
- WB Contracted Clinical Research Site
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Texas
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McKinney, Texas, Forenede Stater, 75069
- Rekruttering
- WB Contracted Clinical Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Adults aged 40 to 80 years
- Post-BD spirometry at screening FEV1/FVC < 0.70 and FEV1 30-80% predicted
- On stable triple inhaled therapy (ICS/LABA/LAMA) for ≥ 3 months
- Former smoker (≥ 10 pack-year history) and abstinence from smoking for ≥ 6 months
- Elevated eosinophil count
- Weight/BMI within allowed range
Exclusion Criteria:
- Clinically significant pulmonary disease other than chronic obstructive pulmonary disease (COPD)
- Clinically significant comorbid medical conditions or infections that, in the investigator's judgment, could affect participant safety or interfere with study conduct
- Clinically significant cardiovascular disease
- Recent respiratory infection or COPD exacerbation
- Exposure to approved or experimental biologic therapies for COPD with less than 5 half-life washout period
- Pregnancy or breastfeeding
- Smoking or diagnosed substance use disorder
- Any condition or circumstance that, in the investigator's opinion, would make participation unsafe or compromise study integrity
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: WIN378 Dose 1
WIN378 SC injections will be administered
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WIN378 is a fully human, long-acting monoclonal antibody that targets the ligand of thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving COPD control over an extended dosing interval
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Eksperimentel: WIN378 Dose 2
WIN378 SC injections will be administered
|
WIN378 is a fully human, long-acting monoclonal antibody that targets the ligand of thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving COPD control over an extended dosing interval
|
|
Eksperimentel: Placebo
Placebo SC injections will be administered
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Placebo matching WIN378
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with Adverse Events (AEs)
Tidsramme: Week 0 - Week 36
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Week 0 - Week 36
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Number of participants with Serious Adverse Events (SAEs)
Tidsramme: Week 0 - Week 36
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Week 0 - Week 36
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Change from baseline in systolic blood pressure (mmHg)
Tidsramme: Week 0 - Week 36
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Week 0 - Week 36
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Change from baseline in diastolic blood pressure (mmHg)
Tidsramme: Week 0 - Week 36
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Week 0 - Week 36
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Change from baseline in pulse rate (beats/minute)
Tidsramme: Week 0 - Week 36
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Week 0 - Week 36
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Change from baseline in respiratory rate (breaths/minute)
Tidsramme: Week 0 - Week 36
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Week 0 - Week 36
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Change from baseline in oxygen saturation (%)
Tidsramme: Week 0 - Week 36
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Week 0 - Week 36
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Change from baseline in body weight (kg)
Tidsramme: Week 0 - Week 36
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Week 0 - Week 36
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Change from baseline in body mass index (kg/m^2)
Tidsramme: Week 0 - Week 36
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Week 0 - Week 36
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Change from baseline in body temperature (°C)
Tidsramme: Week 0- Week 36
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Week 0- Week 36
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Change from baseline in clinical chemistry laboratory assessments
Tidsramme: Week 0 - Week 36
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Clinical chemistry assessments will include serum chemistry (such as sodium, potassium, urea, creatinine) and liver function parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin.
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Week 0 - Week 36
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Change from baseline in haematology laboratory parameters
Tidsramme: Week 0 - Week 36
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Haematology assessments will include haemoglobin, white blood cell count, differential white blood cell counts and platelet count
|
Week 0 - Week 36
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Change from baseline in coagulation laboratory parameters
Tidsramme: Week 0 - Week 36
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Coagulation assessments will include activated partial thromboplastin time, international normalised ratio, prothrombin time and fibrinogen
|
Week 0 - Week 36
|
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Change from baseline in urinalysis parameters
Tidsramme: Week 0 - Week 36
|
Urinalysis assessments will include protein, pH, blood, glucose and leucocytes
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Week 0 - Week 36
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Change from baseline in electrocardiogram QT interval
Tidsramme: Week 0 - Week 36
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Electrocardiogram assessments will include evaluation of QT interval corrected using Fridericia's formula (QTcF)
|
Week 0 - Week 36
|
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WIN378 Serum concentration (PK)
Tidsramme: Week 0 to week 36
|
Week 0 to week 36
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline in Blood Eosinophil Count
Tidsramme: Week 0 to Week 24
|
Week 0 to Week 24
|
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Change in Fractional Exhaled Nitric Oxide (FeNO)
Tidsramme: Week 0 to Week 24
|
Week 0 to Week 24
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Change in Pre and Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: Week 0 to Week 24
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Week 0 to Week 24
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Change in Pre and Post Bronchodilator Forced Vital Capacity (FVC)
Tidsramme: Week 0 to Week 24
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Week 0 to Week 24
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Incidence and magnitude of anti-drug antibodies to WIN 378
Tidsramme: Week 0 to Week 36
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Week 0 to Week 36
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Omar Khwaja, MD, Windward Bio
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. juni 2026
Primær færdiggørelse (Anslået)
17. december 2027
Studieafslutning (Anslået)
7. januar 2028
Datoer for studieregistrering
Først indsendt
2. juni 2026
Først indsendt, der opfyldte QC-kriterier
9. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- WB-2102
- U1111-1333-4974 (Anden identifikator: UTN, World Health Organization (WHO))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med WIN378
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Windward BioAktiv, ikke rekrutterendeAstma (diagnose)Forenede Stater, Argentina, Australien, Bulgarien, Frankrig, Tyskland, Spanien, Sverige