Phase 1 Open-Label Study to Assess Pharmacokinetic and Pharmacodynamic Parameters Following Dosing with an Anti-Tumor Necrosis Factor Monoclonal Antibody (Humira®, adalimumab) Enema in Patients with Active Ulcerative Colitis.

Progenity Inc0 个研究点目标入组 4 人开始时间: 2020年9月18日最近更新: 2022年2月7日

研究概览

暂无简介。

•Subject must provide consent to participate in the study prior to any study procedures are performed
•- UC diagnosis for at least 3 months. .
•- Active colitis:
•- Drug stabilisation requirements, if on one or more of the following medications: oral corticosteroid treatment, oral aminosalicylates, Azathioprine or 6 mercaptopurine, Vedolizumab, Tofacitinib, Ustekinumab
•- Women of childbearing potential must agree to use birth control

•- Diagnosis of (or clinical findings suggestive of) Crohn’s disease or indeterminate colitis
•- Diagnosis of UC limited to rectum
•- Evidence of fulminant colitis
•- Need for colostomy or ileostomy (within 3 months)
•- Previous total or subtotal colectomy or any surgical resection
•- Prior exposure to adalimumab
•- Prior hypersensitivity reaction to any anti TNF therapy
•- Recent or current use of any anti TNF agent
•- Current rectal therapy for UC
•- Current use of intravenous corticosteroid for UC
•- History of renal insufficiency or failure
•- History of untreated colonic dysplasia
•- Planned surgery over the duration of the study
•- History of drug or alcohol abuse
•- History of tuberculosis (TB) exposure or latent TB
•- Evidence of invasive fungal infections
•- History of central or peripheral nervous system demyelinating disorders
•- History of congestive heart failure
•- Evidence of HIV, hepatitis B, or hepatitis C
•- Evidence of active cytomegalovirus (CMV) infection or CMV colitis
•- Recent or current need for a live vaccine
•- Positive stool culture for enteric pathogens
•- Stool positive for Clostridium difficile toxin
•- Recent treatment with an investigational (chemical or biological) product
•- Women who are lactating or breast-feeding.

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