A Phase IIa Randomised, Double Blind, Placebo Controlled,... | EligiMed

A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 Weeks, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

CompletadoFase 2ClinicalTrials.gov

ID: NCT05492877RENIS: IS004307Tipo: INTERVENTIONALInicio: 14 de nov de 2022Fin estimado: 12 de ago de 2024

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Resumen

This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.

Descripción detallada

Study D6582C00001 is a phase IIa randomised, double blind, placebo controlled, parallel arm study to evaluate the efficacy and safety of Mitiperstat (AZD4831) in adult participants with moderate to severe chronic obstructive pulmonary disease. Approximately 100 sites globally will participate in this study. Approximately 406 participants will be randomised to two treatment groups; Mitiperstat (AZD4831) vs placebo in a 1:1 ratio.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Provision of informed consent.
Participants must be deemed as high risk of exacerbations as defined by: \>= 1 moderate or severe exacerbation in the previous 24 months; or frequent productive cough; or post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) \< 50% predicted.
Participants must be 40-80 years of age inclusive, at the time of signing informed consent form (ICF).
Participants who have a confirmed primary diagnosis of moderate to severe COPD.
Participants who are current or ex-smokers with a tobacco history of ≥ 10 pack-years.
Participants who have a documented stable regimen of triple therapy or dual therapy for
≥ 3 months prior to enrolment.
Body mass index within the range 18 to 40 kg/m2 (inclusive).

Criterios de exclusión

As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (at SV1 \[screening\] and SV3 \[pre-dose\]) which in the investigator's opinion makes it undesirable for the participant to participate in the study.
Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years.
Clinically important pulmonary disease other than COPD.
Any other clinically relevant abnormal findings on physical examination, laboratory testing including haematology, coagulation, serum chemistry, or urinalysis; or chest CT scan at screening or randomisation, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study.
History of a clinically significant infection (viral, bacterial, or fungal; defined as requiring systemic antibiotics, antiviral, or antifungal medication for \> 7 days) within 4 weeks prior to SV3 (Day 1) (including unexplained diarrhoea) or clinical suspicion of infection at time of dosing.

Intervenciones

drug

Mitiperstat (AZD4831)

Oral dosage, once daily.

other

Placebo

Oral dosage, once daily.

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Ranelagh, Argentina

Research Site

San Fernando, Argentina

Patrocinadores

PrincipalAstraZeneca

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