Trial · NCT05037929
A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
NCT05037929, Phase 2, Completed, Genentech, Inc.
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease. Trials, record NCT05037929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05037929
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
- NCT number
- NCT05037929
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,334 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Astegolimab, Placebo
- First posted
- 2021-09-08
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Each source's terms
- 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05037929
GET https://conductscience.org/api/trials/v1/NCT05037929/registered