CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
mavrilimumab +2 morecombination
Likely dose
mavrilimumab 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03827018
NCT03827018Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis

Kiniksa Pharmaceuticals, Ltd.·interventional·Posted Feb 1, 2019·Updated Oct 23, 2023

In Brief

A Phase 2 clinical trial evaluating mavrilimumab, placebo, and 1 other intervention for Giant Cell Arteritis. Completed, enrolled 70 participants across 49 sites in 15 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGiant Cell Arteritis
CountriesAustralia, Belgium, Croatia, Estonia, Germany, Ireland, Italy, Netherlands, New Zealand, Poland, Serbia, Slovenia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 1, 2019
Enrollment StartSep 20, 2018
Primary CompletionAug 13, 2020
Study CompletionNov 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.4 years ago

Interventions

mavrilimumabcombination

1 mL of 150 mg in a pre-filled syringe

placebocombination

1 mL of placebo in a pre-filled syringe

prednisonedrug

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)