Trial · NCT04120402
Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee
NCT04120402, Phase 2, Completed, Eupraxia Pharmaceuticals Inc.; results first posted 2024-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee. Trials, record NCT04120402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04120402
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee
- NCT number
- NCT04120402
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 318 participants, actual
- Lead sponsor
- Eupraxia Pharmaceuticals Inc.
- Conditions
- Osteoarthritis, Knee
- Interventions
- EP-104IAR 25 mg, Vehicle
- First posted
- 2019-10-09
- Last updated
- 2024-06-25
- Results first posted
- 2024-06-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale | 12 weeks | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst). Least squares mean from a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC pain score. |
| Secondary | Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Function Subscale | 12 weeks | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale (scores scaled 0-10, with 10 being the worst). Function subscale includes questions related to the physical functioning of osteoarthritis e.g. stair use, standing, walking etc. From a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC function score. |
| Secondary | Difference Between EP-104IAR and Vehicle in the Area Under the Curve (AUC) of WOMAC Pain Subscale | 12 weeks | Area under the curve in change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst) from Week 0 to Week 12 was calculated on a per-individual basis using the linear trapezoidal rule. AUC was normalized to account for subjects whose actual days and nominal days at Week 12 differed. Treatments were compared using an ANCOVA model containing site; individual baseline WOMAC Pain; and treatment group as covariates. |
| Secondary | Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale | 24 weeks | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst). Least squares mean from a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC pain score. |
| Secondary | Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders | 12 weeks | Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) strict responders are defined as at least 50% improvement (decrease from baseline) in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain or function subscales (scores scaled 0-10, with 10 being the worst) and an absolute change of at least 2 in the respective score. Patients who discontinued prior to Week 12 were considered non-responders. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale | 12 weeks | The intention-to-treat (ITT) population consists of all subjects who were both randomized to and received treatment. Analysis was conducted allocating subjects to the treatment to which they were randomized, irrespective of what was actually received. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Function Subscale | 12 weeks | The intention-to-treat (ITT) population consists of all subjects who were both randomized to and received treatment. Analysis was conducted allocating subjects to the treatment to which they were randomized, irrespective of what was actually received. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Difference Between EP-104IAR and Vehicle in the Area Under the Curve (AUC) of WOMAC Pain Subscale | 12 weeks | The intention-to-treat (ITT) population consists of all subjects who were both randomized to and received treatment. Analysis was conducted allocating subjects to the treatment to which they were randomized, irrespective of what was actually received. | score on a scale multiplied by days | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale | 24 weeks | The intention-to-treat (ITT) population consists of all subjects who were both randomized to and received treatment. Analysis was conducted allocating subjects to the treatment to which they were randomized, irrespective of what was actually received. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders | 12 weeks | The intention-to-treat (ITT) population consists of all subjects who were both randomized to and received treatment. Analysis was conducted allocating subjects to the treatment to which they were randomized, irrespective of what was actually received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale | EP-104IAR 25 mg | -2.89 | Standard Error 0.166 | score on a scale | |
| Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale | Placebo (Vehicle) | -2.23 | Standard Error 0.171 | score on a scale | |
| Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Function Subscale | EP-104IAR 25 mg | -2.59 | Standard Error 0.161 | score on a scale | |
| Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Function Subscale | Placebo (Vehicle) | -2.04 | Standard Error 0.166 | score on a scale | |
| Difference Between EP-104IAR and Vehicle in the Area Under the Curve (AUC) of WOMAC Pain Subscale | EP-104IAR 25 mg | -235.67 | Standard Error 11.769 | score on a scale multiplied by days | |
| Difference Between EP-104IAR and Vehicle in the Area Under the Curve (AUC) of WOMAC Pain Subscale | Placebo (Vehicle) | -166.78 | Standard Error 12.169 | score on a scale multiplied by days | |
| Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale | EP-104IAR 25 mg | -2.26 | Standard Error 0.171 | score on a scale | |
| Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale | Placebo (Vehicle) | -2.11 | Standard Error 0.175 | score on a scale | |
| Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders | EP-104IAR 25 mg | 87 | Participants | ||
| Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders | Placebo (Vehicle) | 61 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EP-104IAR 25 mg | 163 | |
| Overall Study | STARTED | Placebo (Vehicle) | 155 | |
| Overall Study | COMPLETED | EP-104IAR 25 mg | 156 | |
| Overall Study | COMPLETED | Placebo (Vehicle) | 148 | |
| Overall Study | NOT COMPLETED | EP-104IAR 25 mg | 7 | |
| Overall Study | NOT COMPLETED | Placebo (Vehicle) | 7 |
Source ClinicalTrials.gov
Adverse events20
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 | Nasopharyngitis | Infections and infestations | EP-104IAR 25 mg | 14 | 163 | 16 |
| other | Nasopharyngitis | Infections and infestations | Placebo (Vehicle) | 12 | 155 | 15 |
| other | COVID-19 | Infections and infestations | EP-104IAR 25 mg | 14 | 163 | 14 |
| other | COVID-19 | Infections and infestations | Placebo (Vehicle) | 14 | 155 | 14 |
| other | Influenza | Infections and infestations | EP-104IAR 25 mg | 6 | 163 | 6 |
| other | Influenza | Infections and infestations | Placebo (Vehicle) | 9 | 155 | 9 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | EP-104IAR 25 mg | 38 | 163 | 38 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo (Vehicle) | 23 | 155 | 26 |
| other | Influenza like illness | General disorders | EP-104IAR 25 mg | 4 | 163 | 5 |
| other | Influenza like illness | General disorders | Placebo (Vehicle) | 10 | 155 | 10 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EP-104IAR 25 mg | 0 | 163 |
| Total, all-cause mortality | Placebo (Vehicle) | 0 | 155 |
| Total, other adverse events | EP-104IAR 25 mg | 76 | 163 |
| Total, other adverse events | Placebo (Vehicle) | 68 | 155 |
| Total, serious adverse events | EP-104IAR 25 mg | 4 | 163 |
| Total, serious adverse events | Placebo (Vehicle) | 1 | 155 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39401503 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EP-104IAR 25 mg vs Placebo (Vehicle): Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders | Trial comparisons |
| EP-104IAR 25 mg vs Placebo (Vehicle): deaths from any cause | Trial comparisons |
| EP-104IAR 25 mg vs Placebo (Vehicle): serious adverse events | Trial comparisons |
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/NCT04120402
GET https://conductscience.org/api/trials/v1/NCT04120402/registered