Trial · NCT04441788
A Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Participants With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis (CB)
NCT04441788, Phase 2, Terminated, Ionis Pharmaceuticals, Inc.; results first posted 2022-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Participants With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis (CB). Trials, record NCT04441788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04441788
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Participants With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis (CB)
- NCT number
- NCT04441788
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Conditions
- Chronic Bronchitis, Chronic Obstructive Pulmonary Disease
- Interventions
- ION-827359, Placebo, ION-827359
- First posted
- 2020-06-22
- Last updated
- 2022-12-20
- Other registries' IDs
- eudract:2020-000210-15
- Results first posted
- 2022-12-20
- Limitations and caveats
The study was terminated based on the toxicology findings from a 9-month study and participants who had not completed the treatment period were instructed to terminate dosing and return for an end of study visit, followed by the 10-week follow-up period.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo | From Baseline up to average of Weeks 13 and 14 | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Baseline was defined as the last non-missing measurement prior to the first study drug administration. The primary time point was defined as the average of weeks 13 and 14. FAS=Full analysis set. |
| Secondary | Change From Baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Respiratory Symptoms (E-RS) Daily Symptom Diary Total Score to the Primary Time Point | From Baseline up to average of weeks 13 and 14 | The E-RS scale is a participant-reported outcome (PRO) designed to measure the symptoms of participants with chronic obstructive pulmonary disease (COPD). The E-RS utilizes 11 respiratory symptom items from the existing and validated 14-item EXACT, which measures symptoms of exacerbation. The E-RS total score quantifies respiratory symptom severity, and 3 domains assess breathlessness (comprised of 5 items, score range \[0-17\]), cough and sputum (comprised of 3 items, score range \[0-11\]), and chest symptoms (comprised of 3 items, score range \[0-12\]). The E-RS was collected on the daily e-diary. The total score was derived by summing the 11-item scores and ranged between 0 to 40 with higher values indicating severe respiratory symptoms. The primary time point was defined as the average of weeks 13 and 14. |
| Secondary | Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time Point | From Baseline to Week 14 | The CAT is an eight-item questionnaire that was completed by the participant and is designed to quantify the impact of COPD symptoms on the health status of participants. Each item is rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score is calculated by summing the scores of all items and ranges from 0 to 40. Higher scores indicate a severe condition (more severe impact of COPD on a participant's life). |
| Secondary | Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time Point | From Baseline to Week 14 | The SGRQ is a participant completed, a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airway disease. The shorter 40-item version (SGRQ-C) which does not specify a Recall Period and has been validated specifically for COPD participants was used in this study. It consists of 40 items each weighted from 0 to a possible maximum of 100. Items 1-7 produced the symptoms score, 9-12 the activity score, and items 8, 10, 11, 13 and 14 the impacts score. Each component sub-score was calculated as a percentage of the summed weights of each item out of the sum of the maximum possible weight for that component (range 0-100). The total score was calculated by summing the weights to all positive responses in each component, where a positive item indicated the presence of symptoms, expressed as a percentage (range 0-100). Higher scores indicated a worse outcome (more limitations) |
| Secondary | Change From Baseline in Post-Bronchodilator FEV1 | From Baseline to end of treatment (EOT) [Up to Week 14] | Post-bronchodilator FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation after administration of bronchodilator. Baseline was defined as the last non-missing measurement prior to the first study drug administration. |
| Secondary | Cmax: Maximum Observed Plasma Concentration for ION-827359 | Days 1 and 85 | |
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359 | Days 1 and 85 | |
| Secondary | AUC[0-24h]: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours for ION-827359 | Days 1 and 85 | |
| Secondary | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) Based on Severity | Up to Week 24 | An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of medicinal (investigational) product, whether or not the AE is considered related to the medicinal (investigational) product. A TEAE is defined as any AE starting or getting worse on or after the first dose of the study drug. The severity of a TEAE was assessed by the investigator and classified into one of the following: mild, moderate, and severe. |
| Secondary | Percentage of Participants With Clinically Significant Change in Laboratory Values | Up to Week 24 | Laboratory parameters for serum chemistry, hematology, urinalysis, coagulation, complement, and lipids were assessed. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo | From Baseline up to average of Weeks 13 and 14 | FAS=all randomized participants who had ≥1 dose of study drug(ION 827359/placebo),≥1 post-Baseline efficacy assessment(i.e.,post-Baseline FEV1,Exacerbations of Chronic pulmonary Disease Tool\[EXACT\]Respiratory Symptoms\[E-RS\]score,Chronic Obstructive Pulmonary Disease\[COPD\]Assessment Test\[CAT\]score,or St.George's Respiratory Questionnaire-COPD Specific\[SGRQ-C score\],post-bronchodilator FEV1).Overall number analyzed:number of participants with data available for analyses in this outcome measure. | liters | MEAN |
| SECONDARY | Change From Baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Respiratory Symptoms (E-RS) Daily Symptom Diary Total Score to the Primary Time Point | From Baseline up to average of weeks 13 and 14 | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time Point | From Baseline to Week 14 | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time Point | From Baseline to Week 14 | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Post-Bronchodilator FEV1 | From Baseline to end of treatment (EOT) [Up to Week 14] | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | liters | MEAN |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration for ION-827359 | Days 1 and 85 | Pharmacokinetic (PK) population included all participants who were randomized and received at least 1 dose of active study drug (ION-827359) and had at least 1 evaluable PK sample collected and analyzed with reportable result. Number analyzed is the number of participants with data available for analysis at the specified time point. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359 | Days 1 and 85 | PK population included all participants who were randomized and received at least 1 dose of active study drug (ION-827359) and had at least 1 evaluable PK sample collected and analyzed with reportable result. Number analyzed is the number of participants with data available for analysis at the specified time point. | hours | MEDIAN |
| SECONDARY | AUC[0-24h]: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours for ION-827359 | Days 1 and 85 | PK population consisted of all the participants who were randomized and received at least 1 dose of active study drug (ION-827359) and had at least 1 evaluable PK sample collected and analyzed with reportable result. Number analyzed is the number of participants with data available for analysis at the specified time point. | hours*nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) Based on Severity | Up to Week 24 | Safety population included all participants who were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Significant Change in Laboratory Values | Up to Week 24 | Safety population included all participants who are were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo | Placebo | 0.0642 | Standard Deviation 0.2506 | liters | |
| Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo | ION-827359 37.5 mg | -0.0240 | Standard Deviation 0.3581 | liters | |
| Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo | ION-827359 75 mg | 0.1336 | Standard Deviation 0.1087 | liters | |
| Change From Baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Respiratory Symptoms (E-RS) Daily Symptom Diary Total Score to the Primary Time Point | Placebo | -1.08 | Standard Deviation 1.171 | score on a scale | |
| Change From Baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Respiratory Symptoms (E-RS) Daily Symptom Diary Total Score to the Primary Time Point | ION-827359 37.5 mg | -1.41 | Standard Deviation 2.486 | score on a scale | |
| Change From Baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Respiratory Symptoms (E-RS) Daily Symptom Diary Total Score to the Primary Time Point | ION-827359 75 mg | -1.99 | Standard Deviation 4.217 | score on a scale | |
| Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time Point | Placebo | -2.6 | Standard Deviation 2.51 | score on a scale | |
| Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time Point | ION-827359 37.5 mg | -0.6 | Standard Deviation 3.78 | score on a scale | |
| Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time Point | ION-827359 75 mg | 0.0 | Standard Deviation 1.73 | score on a scale | |
| Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time Point | Placebo | -15.93 | Standard Deviation 19.515 | score on a scale |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | STARTED | ION-827359 37.5 Milligrams (mg) | 21 | |
| Overall Study | STARTED | ION-827359 75 mg | 19 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | COMPLETED | ION-827359 37.5 Milligrams (mg) | 4 | |
| Overall Study | COMPLETED | ION-827359 75 mg | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | ION-827359 37.5 Milligrams (mg) | 17 | |
| Overall Study | NOT COMPLETED | ION-827359 75 mg | 16 |
Source ClinicalTrials.gov
Adverse events141
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 19 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | ION-827359 37.5 mg | 5 | 21 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | ION-827359 75 mg | 7 | 19 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Placebo | 5 | 19 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | ION-827359 37.5 mg | 0 | 21 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | ION-827359 75 mg | 4 | 19 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 19 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | ION-827359 37.5 mg | 2 | 21 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | ION-827359 75 mg | 5 | 19 | |
| other | Chest pain | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 19 |
1 to 10 of 141Source ClinicalTrials.gov
See all 141 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 19 |
| Total, all-cause mortality | ION-827359 37.5 mg | 0 | 21 |
| Total, all-cause mortality | ION-827359 75 mg | 0 | 19 |
| Total, other adverse events | Placebo | 14 | 19 |
| Total, other adverse events | ION-827359 37.5 mg | 8 | 21 |
| Total, other adverse events | ION-827359 75 mg | 16 | 19 |
| Total, serious adverse events | Placebo | 1 | 19 |
| Total, serious adverse events | ION-827359 37.5 mg | 1 | 21 |
| Total, serious adverse events | ION-827359 75 mg | 1 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04441788
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