Trial · NCT03980522
A Pilot Study of KPL-914 in Recurrent Pericarditis
NCT03980522, Phase 2, Completed, Kiniksa Pharmaceuticals (UK), Ltd.; results first posted 2021-05-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Pilot Study of KPL-914 in Recurrent Pericarditis. Trials, record NCT03980522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03980522
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of KPL-914 in Recurrent Pericarditis
- NCT number
- NCT03980522
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Kiniksa Pharmaceuticals (UK), Ltd.
- Conditions
- Recurrent Pericarditis
- Interventions
- KPL-914
- First posted
- 2019-06-10
- Last updated
- 2021-05-27
- Results first posted
- 2021-05-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Screening Visit 1 (Day -3 to Day 0), Screening Visit 2 (Day -3 to Day 0), Day 0, Baseline (defined as the last non-missing assessment prior to the first study drug administration) | |
| Primary | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Baseline, Treatment Period (TP) Weeks 2, 3, 4, 5, 6, TP Interval Evaluation (between Weeks 3-4), End of TP (up to Week 6), Extension Period (EP): Months 1, 2, 3, 4, EP Interval Evaluation (between Weeks 15-20), Final Visit (up to Week 25) | |
| Primary | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Prescreening, Screening Visit 1 (Day -3 to Day 0), Screening Visit 2 (Day -3 to Day 0), Day 0, Baseline (defined as the last non-missing assessment prior to the first study drug administration) | The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be"). |
| Primary | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Baseline, Treatment Period (TP) Day 3, Weeks 2, 3, TP Interval Evaluation (between Weeks 3-4), 4, 5, 6, End of TP (up to Week 6), Extension Period (EP): Months 1, 2, 3, 4, EP Interval Evaluation (between Weeks 15-20), Final Visit (up to Week 25) | The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be"). |
| Primary | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Baseline, TP Weeks 2, 3, Interval Evaluation Visit (Weeks 3-4), 4, 5, 6, End of TP Visit (Week 6), EP Months 1, 2, 3, 4, EP Interval Evaluation Visit (Week 15-Week 20), Final Visit (up to EP Month 4) | Baseline is defined as the last non-missing assessment prior to the first study drug administration. |
| Primary | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Baseline, TP Day 3, TP Weeks 2, 3, Interval Evaluation Visit (Weeks 3-4), 4, 5, 6, End of TP Visit (Week 6), EP Months 1, 2, 3, 4, EP Interval Evaluation Visit (Week 15-Week 20), Final Visit (up to EP Month 4) | The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be"). Baseline is defined as the last non-missing assessment prior to the first study drug administration. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Screening Visit 1 (Day -3 to Day 0), Screening Visit 2 (Day -3 to Day 0), Day 0, Baseline (defined as the last non-missing assessment prior to the first study drug administration) | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | mg/dL | MEAN |
| PRIMARY | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Baseline, Treatment Period (TP) Weeks 2, 3, 4, 5, 6, TP Interval Evaluation (between Weeks 3-4), End of TP (up to Week 6), Extension Period (EP): Months 1, 2, 3, 4, EP Interval Evaluation (between Weeks 15-20), Final Visit (up to Week 25) | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | mg/dL | MEAN |
| PRIMARY | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Prescreening, Screening Visit 1 (Day -3 to Day 0), Screening Visit 2 (Day -3 to Day 0), Day 0, Baseline (defined as the last non-missing assessment prior to the first study drug administration) | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | score on a scale | MEAN |
| PRIMARY | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Baseline, Treatment Period (TP) Day 3, Weeks 2, 3, TP Interval Evaluation (between Weeks 3-4), 4, 5, 6, End of TP (up to Week 6), Extension Period (EP): Months 1, 2, 3, 4, EP Interval Evaluation (between Weeks 15-20), Final Visit (up to Week 25) | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | score on a scale | MEAN |
| PRIMARY | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Baseline, TP Weeks 2, 3, Interval Evaluation Visit (Weeks 3-4), 4, 5, 6, End of TP Visit (Week 6), EP Months 1, 2, 3, 4, EP Interval Evaluation Visit (Week 15-Week 20), Final Visit (up to EP Month 4) | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | mg/dL | MEAN |
| PRIMARY | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Baseline, TP Day 3, TP Weeks 2, 3, Interval Evaluation Visit (Weeks 3-4), 4, 5, 6, End of TP Visit (Week 6), EP Months 1, 2, 3, 4, EP Interval Evaluation Visit (Week 15-Week 20), Final Visit (up to EP Month 4) | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | KPL-914: Part 1 Participants | Screening Visit 1 | 5.921 | Standard Deviation 5.3423 | mg/dL |
| Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | KPL-914: Part 2 Participants | Screening Visit 1 | 0.645 | Standard Deviation 0.4313 | mg/dL |
| Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | KPL-914: Part 1 Participants | Screening Visit 2 | 4.455 | Standard Deviation 0.4455 | mg/dL |
| Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | KPL-914: Part 1 Participants | Day 0 | 5.156 | Standard Deviation 6.4150 | mg/dL |
| Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | KPL-914: Part 2 Participants | Day 0 | 0.090 | Standard Deviation NA | mg/dL |
| Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | KPL-914: Part 4 Participants | Day 0 | 1.140 | Standard Deviation NA | mg/dL |
| Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | KPL-914: Part 1 Participants | Baseline | 4.907 | Standard Deviation 5.7686 | mg/dL |
| Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | KPL-914: Part 2 Participants | Baseline | 0.460 | Standard Deviation 0.4424 | mg/dL |
| Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | KPL-914: Part 4 Participants | Baseline | 1.140 | Standard Deviation NA | mg/dL |
| Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | KPL-914: Part 1 Participants | Change at TP Week 2 | -5.202 | Standard Deviation 6.0296 | mg/dL |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | KPL-914: Part 1 Participants | 13 | |
| Treatment Period | STARTED | KPL-914: Part 2 Participants | 3 | |
| Treatment Period | STARTED | KPL-914: Part 3 Participants | 6 | |
| Treatment Period | STARTED | KPL-914: Part 4 Participants | 1 | |
| Treatment Period | STARTED | KPL-914: Part 5 Participants | 3 | |
| Treatment Period | COMPLETED | KPL-914: Part 1 Participants | 12 | |
| Treatment Period | COMPLETED | KPL-914: Part 2 Participants | 3 | |
| Treatment Period | COMPLETED | KPL-914: Part 3 Participants | 6 | |
| Treatment Period | COMPLETED | KPL-914: Part 4 Participants | 1 | |
| Treatment Period | COMPLETED | KPL-914: Part 5 Participants | 3 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events295
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 | Injection site reaction | General disorders | KPL-914: Part 1 Participants | 1 | 12 | |
| other | Injection site reaction | General disorders | KPL-914: Part 2 Participants | 0 | 3 | |
| other | Injection site reaction | General disorders | KPL-914: Part 3 Participants | 2 | 6 | |
| other | Injection site reaction | General disorders | KPL-914: Part 4 Participants | 1 | 1 | |
| other | Injection site reaction | General disorders | KPL-914: Part 5 Participants | 2 | 3 | |
| other | Fatigue | General disorders | KPL-914: Part 1 Participants | 0 | 12 | |
| other | Fatigue | General disorders | KPL-914: Part 2 Participants | 0 | 3 | |
| other | Fatigue | General disorders | KPL-914: Part 3 Participants | 1 | 6 | |
| other | Fatigue | General disorders | KPL-914: Part 4 Participants | 0 | 1 | |
| other | Fatigue | General disorders | KPL-914: Part 5 Participants | 1 | 3 |
1 to 10 of 295Source ClinicalTrials.gov
See all 295 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KPL-914: Part 1 Participants | 0 | 12 |
| Total, all-cause mortality | KPL-914: Part 2 Participants | 0 | 3 |
| Total, all-cause mortality | KPL-914: Part 3 Participants | 0 | 6 |
| Total, all-cause mortality | KPL-914: Part 4 Participants | 0 | 1 |
| Total, all-cause mortality | KPL-914: Part 5 Participants | 0 | 3 |
| Total, other adverse events | KPL-914: Part 1 Participants | 12 | 12 |
| Total, other adverse events | KPL-914: Part 2 Participants | 3 | 3 |
| Total, other adverse events | KPL-914: Part 3 Participants | 6 | 6 |
| Total, other adverse events | KPL-914: Part 4 Participants | 1 | 1 |
| Total, other adverse events | KPL-914: Part 5 Participants | 3 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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/NCT03980522
GET https://conductscience.org/api/trials/v1/NCT03980522/results?page=2