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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 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.

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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).

Conditions Studied

Giant Cell Arteritis

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

FieldValue
Enrollment Target 70 participants
Start Date 2018-09-20
Est. Completion 2020-11-25
Phase Phase 2

Sponsor

Kiniksa Pharmaceuticals

3 total trials

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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, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,040-participant average among 7 other Giant Cell Arteritis trials with a reported enrollment target (93% lower). The listed sponsor is Kiniksa Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.