Trial · NCT03827018
KPL-301 for Subjects With Giant Cell Arteritis
NCT03827018, Phase 2, Completed, Kiniksa Pharmaceuticals, Ltd.; results first posted 2023-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. KPL-301 for Subjects With Giant Cell Arteritis. Trials, record NCT03827018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03827018
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- KPL-301 for Subjects With Giant Cell Arteritis
- NCT number
- NCT03827018
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Kiniksa Pharmaceuticals, Ltd.
- Conditions
- Giant Cell Arteritis
- Interventions
- mavrilimumab, placebo, prednisone
- First posted
- 2019-02-01
- Last updated
- 2023-10-23
- Results first posted
- 2023-10-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Flare by Week 26 | Week 26 | Time to flare by Week 26 was defined as time from randomization to the date of first flare occurring within the 26-week period, as assessed by independent adjudication. Kaplan-Meier method used to estimate the survival functions for each treatment arm. Flare/relapse was defined as a C-reactive protein (CRP) of 1 mg/dL or greater and/or erythrocyte sedimentation rate (ESR) of 30 mm/h or greater AND at least one of the following signs or symptoms attributed to GCA: Cranial symptoms (new-onset localized headache; scalp or temporal artery tenderness; ischemic-related vision loss; unexplained mouth or jaw pain upon mastication; transient ischemic attack or stroke related to GCA); Extracranial symptoms (claudication of the extremities; symptoms of polymyalgia rheumatica); New or worsening angiographic abnormalities detected via MRI, CT/CTA, or PET-CT of the aorta or other great vessels or via ultrasound of the temporal arteries. |
| Secondary | Sustained Remission Rate at Week 26 | Week 26 | The sustained remission rate at Week 26 is defined as the percentage of participants with sustained remission, as assessed by independent adjudication, at Week 26, derived from the time to flare curve. Kaplan-Meier Survival Estimates with standard error and 95% CI for each arm. Participants who completed the treatment period without a flare by Week 26 were considered to have sustained remission. |
| Secondary | Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26 | Week 26 | Elevated ESR is defined as first occurrence of ESR value ≥ 30 mm/hr. Participants with elevated ESR within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm. |
| Secondary | Time to Elevated C-Reactive Protein (CRP) by Week 26 | Week 26 | Elevated CRP is defined as first occurrence of CRP value ≥ 1.0 mg/dL. Participants with elevated CRP within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm. |
| Secondary | Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26 | Week 26 | Kaplan-Meier method used to estimate the survival functions for each treatment arm. |
| Secondary | Cumulative Corticosteroid Dose at Week 26 | Week 26 | |
| Secondary | Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal ESR | Week 26 | Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses \< 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals. |
| Secondary | Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal CRP Level | Week 26 | Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses \< 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals. |
| Secondary | Percentage of Participants Who Completed the 26-week Corticosteroid Taper and Who Had No Signs or Symptoms of GCA Nor New or Worsening Vasculitis by Imaging by Week 26 | Week 26 | Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses \< 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals. |
| Secondary | Cumulative Corticosteroid Dose at the End of the Washout Safety Follow-up Period | Final Safety Follow-up visit (Week 38) |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Flare by Week 26 | Week 26 | Modified Intent to Treat (mITT) Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. | weeks | MEDIAN |
| SECONDARY | Sustained Remission Rate at Week 26 | Week 26 | mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. | percentage of participants | NUMBER |
| SECONDARY | Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26 | Week 26 | mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. Participants with elevated ESR within 3 days of first dose are excluded from the analysis. | weeks | MEDIAN |
| SECONDARY | Time to Elevated C-Reactive Protein (CRP) by Week 26 | Week 26 | mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. Participants with elevated CRP within 3 days of first dose are excluded from the analysis. | weeks | MEDIAN |
| SECONDARY | Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26 | Week 26 | mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. | weeks | MEDIAN |
| SECONDARY | Cumulative Corticosteroid Dose at Week 26 | Week 26 | mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. | mg | MEAN |
| SECONDARY | Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal ESR | Week 26 | mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal CRP Level | Week 26 | mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Completed the 26-week Corticosteroid Taper and Who Had No Signs or Symptoms of GCA Nor New or Worsening Vasculitis by Imaging by Week 26 | Week 26 | mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Corticosteroid Dose at the End of the Washout Safety Follow-up Period | Final Safety Follow-up visit (Week 38) | mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. | mg | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Flare by Week 26 | Mavrilimumab | NA | 95% Confidence Interval NA to NA | weeks | |
| Time to Flare by Week 26 | Placebo | 25.1 | 95% Confidence Interval 16.0 to NA | weeks | |
| Sustained Remission Rate at Week 26 | Mavrilimumab | 83.2 | 95% Confidence Interval 67.9 to 91.6 | percentage of participants | |
| Sustained Remission Rate at Week 26 | Placebo | 49.9 | 95% Confidence Interval 29.6 to 67.3 | percentage of participants | |
| Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26 | Mavrilimumab | 26.1 | 95% Confidence Interval 16.1 to NA | weeks | |
| Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26 | Placebo | 12.1 | 95% Confidence Interval 8.1 to 16.6 | weeks | |
| Time to Elevated C-Reactive Protein (CRP) by Week 26 | Mavrilimumab | NA | 95% Confidence Interval 8.1 to NA | weeks | |
| Time to Elevated C-Reactive Protein (CRP) by Week 26 | Placebo | 12.3 | 95% Confidence Interval 3.3 to 24.1 | weeks | |
| Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26 | Mavrilimumab | NA | 95% Confidence Interval NA to NA | weeks | |
| Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26 | Placebo | 25.1 | 95% Confidence Interval 15.1 to NA | weeks |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mavrilimumab | 42 | |
| Overall Study | STARTED | Placebo | 28 | |
| Overall Study | Completed Treatment | Mavrilimumab | 31 | |
| Overall Study | Completed Treatment | Placebo | 12 | |
| Overall Study | COMPLETED | Mavrilimumab | 39 | |
| Overall Study | COMPLETED | Placebo | 25 | |
| Overall Study | NOT COMPLETED | Mavrilimumab | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events60
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 | Constipation | Gastrointestinal disorders | Mavrilimumab | 3 | 42 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 28 | |
| other | Diarrhea | Gastrointestinal disorders | Mavrilimumab | 0 | 42 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 3 | 28 | |
| other | Vomiting | Gastrointestinal disorders | Mavrilimumab | 1 | 42 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 2 | 28 | |
| other | Oedema peripheral | General disorders | Mavrilimumab | 2 | 42 | |
| other | Oedema peripheral | General disorders | Placebo | 2 | 28 | |
| other | Pyrexia | General disorders | Mavrilimumab | 0 | 42 | |
| other | Pyrexia | General disorders | Placebo | 2 | 28 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mavrilimumab | 0 | 42 |
| Total, all-cause mortality | Placebo | 0 | 28 |
| Total, other adverse events | Mavrilimumab | 33 | 42 |
| Total, other adverse events | Placebo | 25 | 28 |
| Total, serious adverse events | Mavrilimumab | 2 | 42 |
| Total, serious adverse events | Placebo | 3 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35264321 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mavrilimumab vs Placebo: deaths from any cause | Trial comparisons |
| Mavrilimumab vs Placebo: 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/NCT03827018
GET https://conductscience.org/api/trials/v1/NCT03827018/events?page=2