Status:
COMPLETED
KPL-301 for Subjects With Giant Cell Arteritis
Lead Sponsor:
Kiniksa Pharmaceuticals, Ltd.
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
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...
Detailed Description
This Phase 2 randomized, double-blind, placebo-controlled proof of concept study will evaluate the efficacy and safety of mavrilimumab co-administered with a 26-week corticosteroid taper in subjects w...
Eligibility Criteria
Inclusion
- Selected
- 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.
- Selected
Exclusion
- 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.
- Evidence of clinically-uncontrolled respiratory disease.
- History of chronic respiratory tract infections.
Key Trial Info
Start Date :
September 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03827018
Start Date
September 20 2018
End Date
November 25 2020
Last Update
October 23 2023
Active Locations (49)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 1703
Sarasota, Florida, United States, 34239
2
Site 1708
Tampa, Florida, United States, 33612
3
Site 1706
Atlanta, Georgia, United States, 30342
4
Site 1701
Boston, Massachusetts, United States, 02114