Clinical trial: KPL-301 for Subjects With Giant Cell Arteritis (NCT03827018)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? 1