EUCTR2021-000091-11-IT进行中（未招募）1 期
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis - ARTEMIS-UC Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female >=18 years of age
- •2. Subjects must have had a documented diagnosis of UC (endoscopy + histology) to be eligible for study participation or UC diagnosis must be confirmed at time of screening colonoscopy
- •3. Moderately to severely active UC
- •4. Subjects must satisfy at least one of the following criteria:
- •a) In the past, had an inadequate response to one or more of the following treatments:
- •i. Oral prednisone, budesonide for at least 2 weeks
- •ii. Corticosteroid dependence as defined by failed to successfully taper to < 10 mg/day of prednisone equivalent within 3 months of starting therapy, or if relapse occurs within 3 months of stopping corticosteroids
- •iii. Immunosuppressants for at least 12 weeks
- •iv. An approved anti-TNF agent at an approved labeled dose for at least 8 weeks
- •v. Vedolizumab at the approved labelled dose for at least 8 weeks
- •vi. An approved JAK inhibitor for at least 8 weeks
- •vii. An approved anti-IL-12/23 for at least 8 weeks
- •viii. An approved sphingosine 1-phosphate receptor (S1PR) modulator for least 12 weeks
- •b) Had been intolerant to one or more of the above-mentioned treatments (e.g., unable to achieve doses or treatment durations because of dose limiting side effects [e.g., leukopenia, psychosis, uncontrolled diabetes, elevated liver enzymes]).
- •c) Currently receiving one or more of the following treatments:
- •i. Oral Prednisone = 10 mg/day (or equivalent) for at least 3months
- •ii. Immunosuppressants [azathioprine = 2 mg/kg/day or 6-mercaptopurine = 1.0 mg/kg/day (or documentation of a therapeutic concentration of 6 thioguanine nucleotide)] for at least 8 weeks
- •Notes on subjects who have had prior biologic/biologic-like therapy(ies) (anti-TNF, JAK inhibitor, anti-IL-23, and/or anti-integrin):
- •i. The study will include a maximum of 70% subjects who have had prior biologic/biologic-like therapy(ies) experience. Upon reaching the maximum number of allowed biologic/biologic-like experienced subjects (70%), subjects who have had prior biologic/biologic-like experience will no longer be allowed to enter the study.
- •ii. Subject cannot have failed (no response, insufficient response, loss of response, and/or intolerance) > 3 classes or > 4 individual biologic/biologic-like therapies (exclusion criterion #26).
- •5. For subjects who are women of childbearing potential (WOCBP) involved in any sexual intercourse that could lead to pregnancy, the subject has used two highly effective methods of contraception for at least 4 weeks prior to Day 1 and agrees to continue to use two highly effective methods of contraception until at least 12 weeks after the last dose of study drug.
- •6. Male subjects must use two highly effective methods of contraception from screening to 12 weeks after the last dose of study drug.
- •7. Subject must meet drug stabilization requirements, as applicable:
- •a) Oral corticosteroid treatment must have been reduced to the equivalent of = 20 mg prednisone or = 9 mg budesonide daily at a stable dose for at least 2 weeks prior to randomization.
- •b) Oral aminosalicylates should be at a stable dose for at least 2 weeks prior to randomization.
- •c) Azathioprine and 6-mercaptopurine should be at a stable dose for at least 4 weeks prior to randomization.
- •8. Able to provide written informed consent and understand and comply with the requirements of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age
排除标准
- •-WOCBP and men with fertile partners who do not wish or cannot use two methods of contraception
- •- Women who are pregnant or breastfeeding.
- •- Women with a positive pregnancy test at enrollment or before randomization.
- •- Diagnosis of Crohn's disease or indeterminate colitis.
- •-CU limited to the rectum.
- •-Current evidence of fulminant colitis, toxic megacolon or intestinal perforation.
- •-Current or imminent need for colostomy or ileostomy.
- •- Previous total proctocolectomy or partial colectomy.
- •-Surgical bowel resection within 3 months prior to screening.
- •- Concomitant primary sclerosing cholangitis (CSP).
- •- Previous or current evidence of low or high-grade colon dysplasia that has not been completely removed.
- •- Subjects with scheduled or foreseeable surgery, with the exception of dermatological procedures.
- •- Individuals with a history of clinically significant drug or alcohol abuse.
- •- Concomitant disease which may require systemic glucocorticosteroid therapy during the study
- •- Concomitant medical conditions that could expose the subject to an unacceptable risk for participation in this study.
- •- a history of cancer within the past 5 years. Any non-melanomatous skin cell tumors that may be present must be removed before enrollment. Subjects with carcinoma in situ or localized cervical cancer, treated with definitive surgery, are admitted.
- •- at risk of tuberculosis (TB), active or not successfully treated.
- •- with any severe bacterial infection within the past 3 months or any chronic bacterial infection
- •- screened for breast cancer suspected of being malignant and for which malignancy cannot reasonably be excluded
- •-affected with active infection prior to randomization.
- •- with reactivation of herpes zoster or CMV resolved less than 2 months before the signing of the ICF.
- •- Get vaccinated with live vaccine within 3 months prior to the first dose of the drug or that they will need it
- •- PCR positive stool or positive fecal culture for enteric pathogens.
- •-Feces positive for C. difficile toxin.
- •- Any of the following values
- •- Hemoglobin <8.0 g / dl
- •- White blood cells <2,500 / mm3
- •- Neutrophils <1,000 / mm3
- •- Platelets <100,000 / mm3
- •- Serum creatinine> 2 times the limit
- •- Alanine aminotransferase or serum aspartate aminotransferase> 2 times the ULN
- •- Failure to respond to> 3 classes (anti-TNF, anti-integrin, anti-IL-12/23, JAK inhibitor, S1PR modulator) or> 4 single biological / biological-like therapies.
- •-Any biological or biologic-like marketed drug within 2 weeks for tofacitinib, 8 weeks for anti-TNF agents, 10 weeks for S1PR modulators, and 12 weeks for vedolizumab and ustekinumab prior to randomization
- •- Any biological immunomodulator not included in exclusion criterion 27
- •-Rituximab within 1 year prior to randomization.
- •- Parenteral corticosteroids within 4 weeks or rectal corticosteroid administration within 2 weeks prior to randomization.
- •-Rectal administration of 5-aminosalicylic acid (5-ASA) within 2 weeks prior to randomization.
- •-Tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, immunosorbent columns, D-Penicillamine, Leflunomide, Thalidomide, fish oil preparations, probiotics, fecal transplant, non-steroidal anti-inflammatory agents (NSAIDs), aspirin.
- •-Other experimental chemical agent in the 30 days or other experimental biological agent in the 8 weeks or 5 half-lives prior to randomization.
- •-Previous exposure to PRA023.
研究者
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