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NCT03827018 · ClinicalTrials.gov registry record · Phase 2
KPL-301 for Subjects With Giant Cell Arteritis
A Phase 2 study of Giant Cell Arteritis, sponsored by Kiniksa Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT03827018: Completed Phase 2 study of Giant Cell Arteritis, sponsored by Kiniksa Pharmaceuticals.
NCT03827018 is a Phase 2 study of Giant Cell Arteritis that has completed, run by Kiniksa Pharmaceuticals. The registered enrollment target is 70 participants, below the 1,040-participant average among 7 other Giant Cell Arteritis trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03827018, a Phase 2 study of Giant Cell Arteritis, has completed, sponsored by Kiniksa Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).
Primary Outcome
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 loc
Conditions Studied
Interventions
- DRUG prednisone
- COMBINATION_PRODUCT mavrilimumab
- COMBINATION_PRODUCT placebo
Study Locations (20)
Other
- Site 2102 - Kogarah
- Site 2105 - Nedlands
- Site 2106 - Parkville
- Site 2101 - Victoria Park
- Site 2104 - Woodville South
- Site 2204 - Brussels
- Site 2202 - Leuven
- Site 2201 - Liège
- Site 2203 - Yvoir
- Site 2303 - Zagreb
- Site 2401 - Tallinn
- Site 2402 - Tartu
Florida
- Site 1703 - Sarasota
- Site 1708 - Tampa
Michigan
- Site 1707 - Lansing
- Site 1704 - Saint Clair Shores
Georgia
- Site 1706 - Atlanta
Massachusetts
- Site 1701 - Boston
Minnesota
- Site 1702 - Rochester
New York
- Site 1705 - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-09-20 |
| Est. Completion | 2020-11-25 |
| Phase | Phase 2 |
What the finished NCT03827018 record still lists
NCT03827018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,040-participant average among 7 other Giant Cell Arteritis trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Giant Cell Arteritis appearing as the primary indexed condition, and to 3 interventions - of which prednisone is the first listed.
NCT03827018 names 20 study sites across 7 states, led by Other, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT03827018 about?
NCT03827018 is a clinical study titled "KPL-301 for Subjects With Giant Cell Arteritis". The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).
What is the current status of trial NCT03827018?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2018-09-20. Estimated completion is 2020-11-25.
What conditions does trial NCT03827018 study?
This clinical trial studies the following conditions: Giant Cell Arteritis.
What interventions are being tested in trial NCT03827018?
The interventions under investigation include: prednisone (DRUG), mavrilimumab (COMBINATION_PRODUCT), placebo (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03827018?
This trial is sponsored by Kiniksa Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03827018 being conducted?
This trial has 20 study locations across Florida, Georgia, Massachusetts, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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