KPL-301 for Subjects With Giant Cell Arteritis
Condition: Giant Cell Arteritis
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
Intervention: mavrilimumab; placebo; prednisone
Intervention description: 1 mL of 150 mg in a pre-filled syringe; 1 mL of placebo 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)
Intervention MeSH terms: Prednisone; Mavrilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Upon successful completion of the screening procedures, diagnosis criteria will be entered into an interactive web response system, and eligible subjects will be stratified for randomized study treatment into two cohorts according to whether subjects have new-onset or relapsing/refractory disease.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: GCA; temporal arteritis; Horton's disease

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).
    

Eligibility criteria:

        Selected Inclusion Criteria:

          1. Subjects with new-onset or relapsing/refractory GCA.

          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.

        Selected Exclusion Criteria:

          1. Transplanted organs (except corneal transplant performed more than 3 months prior to
             randomization).

          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.