Trial · NCT05595642
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
NCT05595642, Phase 3, Completed, Hoffmann-La Roche
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease. Trials, record NCT05595642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05595642
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
- NCT number
- NCT05595642
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,380 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Astegolimab, Placebo
- First posted
- 2022-10-27
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes12
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 | Up to 52 weeks | 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 AER was estimated as the total number of exacerbations observed over the treatment period divided by the total participant-years at risk (participant-years = date of first study drug administration to completion or discontinuation during the double-blind treatment period divided by 365.25 days). The adjusted AER was estimated using negative binomial regression. Adjusted rate values have been reported. A method of dispersion was not specified in the SAP. |
| 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 Per Microliter [Cells/µL]) | Up to 52 weeks | 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 AER was estimated as the total number of exacerbations observed over the treatment period divided by the total participant-years at risk (participant-years = date of first study drug administration to completion or discontinuation during the double-blind treatment period divided by 365.25 days). The adjusted AER was estimated using negative binomial regression. Adjusted rate values have been reported A method of dispersion was not specified in the SAP. |
| Secondary | Time to First Moderate or Severe COPD Exacerbation During the 52-week Treatment Period | Up to 52 weeks | 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 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 lead to hospitalization (duration \> 24 hours) or 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 Saint 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. Adjusted mean of change from baseline (CFB) is reported here. |
| 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. 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 | The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) is a 14-item participant-reported instrument used to assess the frequency, severity, and 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. Adjusted mean of CFB is reported here. |
| Secondary | Percentage of Participants With Improvement in HRQoL at Week 52, as Assessed by SGRQ-C | 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 | Annualized Rate of Severe COPD Exacerbations Over the 52-week Treatment Period | Up to 52 weeks | A severe COPD exacerbation was defined as new or increased COPD symptoms that lead to hospitalization (duration \> 24 hours) or death. The unadjusted AER was estimated as the total number of exacerbations observed over the treatment period divided by the total participant-years at risk (participant-years = date of first study drug administration to completion or discontinuation during the double-blind treatment period divided by 365.25 days). The adjusted AER was estimated using negative binomial regression. Adjusted rate values have been reported. A method of dispersion was not specified in the SAP. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) | Up to a maximum of 62 weeks | An AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability or incapacity; is a congenital anomaly or birth defect; is medically significant. An AESI was defined as any of the following: cases of potential drug-induced liver injury; suspected transmission of an infectious agent by a study treatment; major adverse cardiovascular events (MACE); anaphylaxis, anaphylactoid, and hypersensitivity reactions. |
| Secondary | Number of Participants Who Died or Discontinued Study Due to TEAEs | Up to a maximum of 62 weeks | An AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Participants who died or discontinued the study due to TEAEs will be reported here. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05595642
GET https://conductscience.org/api/trials/v1/NCT05595642/registered