KPL-301 for Subjects With Giant Cell Arteritis
A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis
1 other identifier
interventional
70
14 countries
47
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2018
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2018
CompletedFirst Submitted
Initial submission to the registry
January 25, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2020
CompletedResults Posted
Study results publicly available
October 17, 2023
CompletedOctober 23, 2023
October 1, 2023
1.9 years
January 25, 2019
August 2, 2023
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Flare by Week 26
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 localized headache; scalp or temporal artery tenderness; ischemic-related vision loss; unexplained mouth or jaw pain upon mastication; transient ischemic attack or stroke related to GCA); Extracranial symptoms (claudication of the extremities; symptoms of polymyalgia rheumatica); New or worsening angiographic abnormalities detected via MRI, CT/CTA, or PET-CT of the aorta or other great vessels or via ultrasound of the temporal arteries.
Week 26
Secondary Outcomes (9)
Sustained Remission Rate at Week 26
Week 26
Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26
Week 26
Time to Elevated C-Reactive Protein (CRP) by Week 26
Week 26
Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26
Week 26
Cumulative Corticosteroid Dose at Week 26
Week 26
- +4 more secondary outcomes
Study Arms (2)
mavrilimumab
ACTIVE COMPARATORSubjects randomized to mavrilimumab will receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.
placebo
PLACEBO COMPARATORSubjects randomized to placebo will receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.
Interventions
1 mL of 150 mg in a pre-filled syringe
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)
Eligibility Criteria
You may qualify if:
- Subjects with new-onset or relapsing/refractory GCA.
- Westergren erythrocyte sedimentation rate \> 30 mm/hour or c-reactive protein ≥ 1 mg/ dL.
- Remission of GCA at or before Day 0.
- Female subjects must be postmenopausal or permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation or having a male partner with vasectomy as affirmed by the subject, or nonpregnant, nonlactating, and if sexually active having agreed to use a highly effective method of contraception.
- Male subjects must have documented vasectomy or if sexually active must agree to use a highly effective method of contraception with their partners of childbearing potential.
You may not qualify if:
- Transplanted organs (except corneal transplant performed more than 3 months prior to randomization).
- Concurrent enrollment in another interventional clinical study.
- Treatment with non-biologic investigational drug therapy within 4 weeks or 5 half-lives of the study agent, whichever was longer, prior to screening.
- Cell-depleting biological therapies within 12 months prior to Day 0, or noncell-depleting biological therapies within 8 weeks (or 5 half-lives, whichever is longer) prior to screening.
- Treatment with alkylating agents within 12 weeks prior to screening.
- Intramuscular, Intra-articular or IV corticosteroids within 4 weeks prior to screening.
- Receipt of live (attenuated) vaccine within the 4 weeks before Day 0.
- Treatment with hydroxychloroquine, cyclosporine A, azathioprine, cyclophosphamide, or mycophenolate mofetil (MMF) within 4 weeks of screening.
- Female subjects who are pregnant, intending to become pregnant, or are breastfeeding.
- Known history of allergy or reaction to any component of the mavrilimumab or placebo formulation or to any other biologic therapy or prednisone or any of its excipients.
- Positive (or 2 indeterminate) QuantiFERON test results.
- Clinically significant active infection or infection requiring hospitalization or IV antibiotics within 12 weeks before screening or opportunistic infection within 6 months before screening.
- Chronic active hepatitis B infection.
- Subjects at a high risk of infection, a history of an infected joint prosthesis still in situ, leg ulcers, indwelling urinary catheter, or persistent or recurrent chest infections.
- History of cancer within the last 10 years, except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Site 1703
Sarasota, Florida, 34239, United States
Site 1708
Tampa, Florida, 33612, United States
Site 1706
Atlanta, Georgia, 30342, United States
Site 1701
Boston, Massachusetts, 02114, United States
Site 1707
Lansing, Michigan, 48910, United States
Site 1704
Saint Clair Shores, Michigan, 48081, United States
Site 1702
Rochester, Minnesota, 55905-0001, United States
Site 1705
New York, New York, 10021, United States
Site 2102
Kogarah, 2217, Australia
Site 2105
Nedlands, 6009, Australia
Site 2106
Parkville, 3050, Australia
Site 2101
Victoria Park, 6100, Australia
Site 2104
Woodville South, 5011, Australia
Site 2204
Brussels, 1070, Belgium
Site 2202
Leuven, 3000, Belgium
Site 2201
Liège, 4000, Belgium
Site 2203
Yvoir, 5530, Belgium
Site 2303
Zagreb, 10 000, Croatia
Site 2401
Tallinn, 11312, Estonia
Site 2402
Tartu, 50708, Estonia
Site 2502
Tübingen, Baden-Wurttemberg, 72076, Germany
Site 2504
Erlangen, Bavaria, 91054, Germany
Site 2507
Freiburg im Breisgau, 79106, Germany
Site 2506
Hamburg, 22763, Germany
Site 2503
Hanover, 30625, Germany
Site 2508
Jena, 07747, Germany
Site 2501
Kirchheim unter Teck, 73230, Germany
Site 2601
Dublin, D04 T6F4, Ireland
Site 2703
Milan, 20132, Italy
Site 2701
Pieve Emanuele, 20090, Italy
Site 2702
Reggio Emilia, 42100, Italy
Site 2704
Udine, 33100, Italy
Site 2802
Groningen, 9713 GZ, Netherlands
Site 2801
Rotterdam, 3015 GD, Netherlands
Site 2902
Christchurch, 8083, New Zealand
Site 2901
Wellington, 6021, New Zealand
Site 1002
Krakow, 31-121, Poland
Site 1101
Belgrade, 11000, Serbia
Site 1102
Belgrade, 11000, Serbia
Site 1103
Belgrade, 11000, Serbia
Site 1201
Ljubljana, 1000, Slovenia
Site 1303
A Coruña, 15006, Spain
Site 1301
Barcelona, 08036, Spain
Site 1304
Bilbao, 48013, Spain
Site 1302
Santa Cruz de Tenerife, 38320, Spain
Site 1604
Edinburgh, EH4 2XU, United Kingdom
Site 1603
Essex, SS0 0RY, United Kingdom
Site 1602
London, E11 1NR, United Kingdom
Site 1601
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (1)
Cid MC, Unizony SH, Blockmans D, Brouwer E, Dagna L, Dasgupta B, Hellmich B, Molloy E, Salvarani C, Trapnell BC, Warrington KJ, Wicks I, Samant M, Zhou T, Pupim L, Paolini JF; KPL-301-C001 Investigators. Efficacy and safety of mavrilimumab in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 May;81(5):653-661. doi: 10.1136/annrheumdis-2021-221865. Epub 2022 Mar 9.
PMID: 35264321DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations Study Director
- Organization
- Kiniksa Pharmaceuticals (UK), Ltd. c/o Kiniksa Pharmaceuticals Corp.
Study Officials
- STUDY DIRECTOR
John Paolini, M.D.
Kiniksa Pharmaceuticals, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2019
First Posted
February 1, 2019
Study Start
September 20, 2018
Primary Completion
August 13, 2020
Study Completion
November 25, 2020
Last Updated
October 23, 2023
Results First Posted
October 17, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share