Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period	Baseline up to Week 52	A moderate COPD exacerbation was defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead to treatment (duration ≥ 3 days) with systemic corticosteroids (oral, intravenous \[IV\], or intramuscular \[IM\]) at a dose of \> 10 milligrams per day (mg/day) prednisolone equivalent and/or antibiotics. A severe COPD exacerbation was defined as new or increased COPD symptoms that lead to hospitalization (duration \> 24 hours) or death. The unadjusted annual exacerbation rate (AER) was estimated as the total number of moderate and severe COPD exacerbations over the treatment period divided by the total patient-years at risk. The time at risk (in years) was the number of days from the date of first administration of study drug to the date of study completion or discontinuation in the 52-week treatment period, divided by 365.25 days. The adjusted AER was estimated using a negative binomial regression model. Adjusted rate values have been reported.
Secondary	Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period in Participants With Low Baseline Blood Eosinophil Level (< 300 Cells/uL)	Baseline to Week 52	A moderate COPD exacerbation was defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead to treatment (duration ≥ 3 days) with systemic corticosteroids (oral, IV, or IM) at a dose of \>10 mg/day prednisolone equivalent and/or antibiotics. A severe COPD exacerbation was defined as new or increased COPD symptoms that led to hospitalization (duration \> 24 hours) or death. Unadjusted AER was estimated as the total number of moderate and severe COPD exacerbations over the treatment period divided by the total patient-years at risk. The time at risk (in years) was the number of days from the date of first administration of study drug to the date of study completion or discontinuation in the 52-week treatment period, divided by 365.25 days. The adjusted AER was estimated using a negative binomial regression model. Adjusted rate values are reported. Number analyzed is the number of participants with data available for analysis.
Secondary	Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period	Baseline up to Week 52	Time to first moderate or severe COPD exacerbation was defined as the time from the first administration of study drug to the first incidence of moderate or severe COPD exacerbation event during the 52-week treatment period. A moderate COPD exacerbation is defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead to treatment (duration ≥ 3 days) with systemic corticosteroids (oral, IV, or IM) at a dose of \> 10 mg/day prednisolone equivalent and/or antibiotics. A severe COPD exacerbation is defined as new or increased COPD symptoms that lead to hospitalization (duration \> 24 hours) or lead to death. Kaplan-Meier (K-M) method was used to estimate the median time.
Secondary	Absolute Change From Baseline in Health-related Quality-of-life (HRQoL) at Week 52, as Assessed Through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) Total Score	At Week 52	SGRQ-C is a disease-specific, self-administered instrument designed to assess the impact of COPD on participants' health status and well-being based on their perception of COPD-related experiences. The questionnaire consists of 40 items across three sub-domains: symptoms (respiratory symptoms and severity- 7 items), activity (activities causing or limited by breathlessness-13 items) and impacts (social functioning and psychological disturbances due to airway disease- 20 items). Each response is assigned a unique empirically derived weight. Total score is calculated by summing the weights to all the positive responses across each domain, with scores ranging from 0 (no impairment) to 100 (maximum impairment), with lower scores indicating better HRQoL. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean of change from baseline (CFB) is reported here.
Secondary	Percentage of Participants With Improvement in HRQoL at Week 52, as Assessed Through SGRQ-C Total Score	At Week 52	Percentage of participants with SGRQ-C improvement was defined as the percentage of participants with an absolute decrease from baseline of ≥4 points in SGRQ-C total score. SGRQ-C is a disease-specific, self-administered instrument designed to assess the impact of COPD on participants' health status and well-being based on their perception of COPD-related experiences. The questionnaire consists of 40 items across three sub-domains: symptoms (respiratory symptoms and severity- 7 items), activity (activities causing or limited by breathlessness-13 items) and impacts (social functioning and psychological disturbances due to airway disease- 20 items). Each response is assigned a unique empirically derived weight. Total score is calculated by summing the weights to all the positive responses across each domain, with scores ranging from 0 (no impairment) to 100 (maximum impairment), with lower scores indicating better HRQoL.
Secondary	Absolute Change From Baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Liters) at Week 52	At Week 52	Post-bronchodilator FEV1 was defined as the FEV1 value measured with spirometry 20-30 minutes after bronchodilator use. Maximal bronchodilation was achieved via administration of either albuterol (90 micrograms \[µg\] metered dose) or salbutamol (100 µg metered dose), with or without a spacer device, up to a maximum of 4 inhalations. This analysis used a MMRM model. Adjusted mean of CFB is reported here.
Secondary	Absolute Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52	At Week 52	EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) is a 14-item participant-reported instrument used to assess frequency, severity, \& duration of COPD exacerbations using a daily electronic diary (eDiary). It includes four domains: breathlessness (5 items), cough and sputum (3 items), chest symptoms (3 items), and additional attributes (tired or weak, sleep disturbance, and scared or worried; 3 items). The E-RS:COPD is an 11-item subset of the EXACT designed to assess the severity of cardinal respiratory symptoms of COPD, including breathlessness, cough, sputum, chest congestion, and chest tightness. It consists of three subscales: RS-Breathlessness, RS-Cough \& Sputum, and RS-Chest Symptoms. Items are scored on 5- or 6-point Likert scales, and the total score is calculated by summing the item scores, ranging from 0 (no impact) to 40 (high impact), with higher scores indicating greater symptom severity. This analysis used a MMRM model. Adjusted mean of CFB has been reported here.
Secondary	Annualized Rate of Severe COPD Exacerbations Over the 52-week Treatment Period	Baseline up to Week 52	A severe COPD exacerbation was defined as new or increased COPD symptoms that lead to hospitalization (duration \> 24 hours) or lead to death. The unadjusted annual exacerbation rate (AER) was estimated as the total number of moderate and severe COPD exacerbations over the treatment period divided by the total patient-years at risk. The time at risk (in years) was the number of days from the date of first administration of study drug to the date of study completion or discontinuation in the 52-week treatment period, divided by 365.25 days. The adjusted AER was estimated using a negative binomial regression model. Adjusted rate values have been reported.
Secondary	Absolute Change From Baseline in Five-repetition Sit-to-stand (5STS) Time (Seconds) at Week 52	At Week 52	The 5STS was used to assess the time taken to stand up from a seated position five times, in as rapid succession as possible. The functional test related strongly to lower limb function and frailty in participants with COPD; an inability to perform a single sit-to-stand or to complete five repeat sit-to-stands within 60 seconds denoted an inability to perform the test. This analysis used a MMRM model. Adjusted mean values have been reported.
Secondary	Number of Participants With Adverse Events (AEs)	Up to 98.1 weeks	An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Secondary	Main Study: Serum Concentrations of Astegolimab at Specified Timepoints	Period 1: Pre-dose on Day 1 of Week 1 and at Weeks 4, 12, 24, 36, 52 and 62 (SFU); Period 2: Pre-dose at Weeks 52, 64, 76, 88, and 98 (SFU)	PK samples in the main study were collected during the 52-week double-blinded treatment period (Period 1), additional blinded treatment period (Period 2), and SFU period.
Secondary	Intensive PK Sampling Substudy: Serum Concentrations of Astegolimab at Specified Timepoints	Period 1: Pre-dose on Day 1 of Week 1 and at Weeks 4, 12, 24, 36, 48, 52, and 62 (SFU), Post-dose on Days 3, 7, and 10 of Week 1, Day 7 of Week 48, Day 28 post-dose from Week 52; Period 2: Pre-dose at Weeks 52, 64, 76, 88, and 98 (SFU)	PK samples in the intensive PK sampling substudy were collected during the 52-week double-blinded treatment period (Period 1), additional blinded treatment period (Period 2), and SFU period.
Secondary	Number of Participants With Anti-drug Antibodies (ADAs) to Astegolimab	Up to 98.1 weeks	Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following astegolimab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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