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KPL-301 for Subjects With Giant Cell Arteritis

NCT03827018 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-10-23

Study results available
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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

  • Giant Cell Arteritis

Interventions

COMBINATION_PRODUCT

mavrilimumab

1 mL of 150 mg in a pre-filled syringe

COMBINATION_PRODUCT

placebo

1 mL of placebo in a pre-filled syringe

DRUG

prednisone

Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP)

Sponsors & Collaborators

  • Kiniksa Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • John Paolini, M.D. · Kiniksa Pharmaceuticals, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2020-08-13
Completion
2020-11-25
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Croatia
  • Estonia
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Serbia
  • Slovenia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03827018 on ClinicalTrials.gov