Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2018-09-20
2020-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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mavrilimumab
Subjects randomized to mavrilimumab will receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.
mavrilimumab
1 mL of 150 mg in a pre-filled syringe
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)
placebo
Subjects randomized to placebo will receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.
placebo
1 mL of placebo in a pre-filled syringe
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)
Interventions
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mavrilimumab
1 mL of 150 mg in a pre-filled syringe
placebo
1 mL of placebo in a pre-filled syringe
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Westergren erythrocyte sedimentation rate \> 30 mm/hour or c-reactive protein ≥ 1 mg/ dL.
3. Remission of GCA at or before Day 0.
4. 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.
5. 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.
Exclusion Criteria
2. Concurrent enrollment in another interventional clinical study.
3. Treatment with non-biologic investigational drug therapy within 4 weeks or 5 half-lives of the study agent, whichever was longer, prior to screening.
4. 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.
5. Treatment with alkylating agents within 12 weeks prior to screening.
6. Intramuscular, Intra-articular or IV corticosteroids within 4 weeks prior to screening.
7. Receipt of live (attenuated) vaccine within the 4 weeks before Day 0.
8. Treatment with hydroxychloroquine, cyclosporine A, azathioprine, cyclophosphamide, or mycophenolate mofetil (MMF) within 4 weeks of screening.
9. Female subjects who are pregnant, intending to become pregnant, or are breastfeeding.
10. 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.
11. Positive (or 2 indeterminate) QuantiFERON test results.
12. Clinically significant active infection or infection requiring hospitalization or IV antibiotics within 12 weeks before screening or opportunistic infection within 6 months before screening.
13. Chronic active hepatitis B infection.
14. 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.
15. 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.
16. Evidence of clinically-uncontrolled respiratory disease.
17. History of chronic respiratory tract infections.
50 Years
85 Years
ALL
No
Sponsors
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Kiniksa Pharmaceuticals, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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John Paolini, M.D.
Role: STUDY_DIRECTOR
Kiniksa Pharmaceuticals, Ltd.
Locations
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Site 1703
Sarasota, Florida, United States
Site 1708
Tampa, Florida, United States
Site 1706
Atlanta, Georgia, United States
Site 1701
Boston, Massachusetts, United States
Site 1707
Lansing, Michigan, United States
Site 1704
Saint Clair Shores, Michigan, United States
Site 1702
Rochester, Minnesota, United States
Site 1705
New York, New York, United States
Site 2102
Kogarah, , Australia
Site 2105
Nedlands, , Australia
Site 2106
Parkville, , Australia
Site 2101
Victoria Park, , Australia
Site 2104
Woodville South, , Australia
Site 2204
Brussels, , Belgium
Site 2202
Leuven, , Belgium
Site 2201
Liège, , Belgium
Site 2203
Yvoir, , Belgium
Site 2303
Zagreb, , Croatia
Site 2401
Tallinn, , Estonia
Site 2402
Tartu, , Estonia
Site 2502
Tübingen, Baden-Wurttemberg, Germany
Site 2504
Erlangen, Bavaria, Germany
Site 2507
Freiburg im Breisgau, , Germany
Site 2506
Hamburg, , Germany
Site 2503
Hanover, , Germany
Site 2508
Jena, , Germany
Site 2501
Kirchheim unter Teck, , Germany
Site 2601
Dublin, , Ireland
Site 2703
Milan, , Italy
Site 2701
Pieve Emanuele, , Italy
Site 2702
Reggio Emilia, , Italy
Site 2704
Udine, , Italy
Site 2802
Groningen, , Netherlands
Site 2801
Rotterdam, , Netherlands
Site 2902
Christchurch, , New Zealand
Site 2901
Wellington, , New Zealand
Site 1002
Krakow, , Poland
Site 1101
Belgrade, , Serbia
Site 1102
Belgrade, , Serbia
Site 1103
Belgrade, , Serbia
Site 1201
Ljubljana, , Slovenia
Site 1303
A Coruña, , Spain
Site 1301
Barcelona, , Spain
Site 1304
Bilbao, , Spain
Site 1302
Santa Cruz de Tenerife, , Spain
Site 1604
Edinburgh, , United Kingdom
Site 1603
Essex, , United Kingdom
Site 1602
London, , United Kingdom
Site 1601
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KPL-301-C001
Identifier Type: -
Identifier Source: org_study_id
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