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KPL-301 for Subjects With Giant Cell Arteritis
NCT03827018 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03827018
The ClinicalTrials.gov registry entry for NCT03827018 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kiniksa Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03827018 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03827018?
The interventions under investigation include: prednisone (DRUG), mavrilimumab (COMBINATION_PRODUCT), placebo (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03827018?
This trial is sponsored by Kiniksa Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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