Badanie fazy II/III leku KPL-387: Pericarditis

Kryteria wyłączenia kto nie może wziąć udziału (11)

1. Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
2. Phase 2 and 3: Has received an investigational drug during the 4 weeks before screening or is planning to receive an investigational drug at any time during the study.
3. Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
4. Phase 2 and 3: Has a history of immunodeficiency.
5. Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
6. Phase 2 and 3: Has chest x-ray at Screening or within 12 weeks before first study drug administration, with evidence of malignancy, abnormality consistent with prior or active TB infection or active infection.
7. Phase 2 and 3: Has a history of malignancy of any organ system within the past 5 years before Screening (other than a successfully treated non metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
8. Phase 2 and 3: Has a known or suspected current active infection or a history of chronic or recurrent infectious disease (> 3 episodes in prior 12 months), including but not limited to, genitourinary infection, chest infection, sinusitis, or skin/soft tissue infection.
9. Phase 2 and 3: Has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring antibiotics for a documented infection within 2 weeks prior to first study drug administration.
10. Phase 2 and 3: Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
11. Phase 2 and 3: In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.