EUCTR2018-003558-26-IT进行中（未招募）1 期
A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - ABX464-103
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Abivax
- 入组人数
- 232
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
- •A patient will be eligible to participate in this study if ALL the following criteria are met:
- •- Men or women age 18 - 75 years;
- •- Diagnosis of moderate to severe active UC confirmed by endoscopy and histology at least 12 Weeks prior to screening visit. Moderate to severe active UC defined by MMS of 4 to 9 inclusive (on a scale of 0-9). Moderate to severe active UC should be confirmed at screening visit with a centrally read endoscopy sub-score of at least 2 (on a scale of 0-3);
- •- Patients having either a documented inadequate response, no response, a loss of response, or an intolerance to either immunosuppressant treatment, tumor necrosis factor [TNF] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.
- •- Patients receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent (<=16 mg/day) or on beclomethasone diproprionate (<=5mg/day) or on budesonide MMX (<=6mg/day) for at least 2 Weeks prior to the screening visit;
- •- Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn at least 2 Weeks prior to the screening visit;
- •- Patients who are on oral 5-aminosalicylic acid must have been on a stable dose for at least 4 Weeks prior to the screening visit;
- •- Patients who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine, or methotrexate needed to be on a stable dose for at least 4 Weeks prior to screening visit. Patients taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication;
- •- Patients on probiotics must be on stable doses for at least 2 Weeks prior to the screening visit;
- •- Patients on antidiarrheals must be on stable doses for at least 2 Weeks prior to the screening visit;
- •- Patients who have received tumor necrosis factor [TNF] inhibitors, vedolizumab or other biologics must have discontinued therapy at least 8 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
- •- Patients previously treated with cyclosporine, tacrolimus or JAK inhibitors must have discontinued therapy at least 4 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
- •- Patients previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 Weeks before the screening visit and must be able to take, orally, appropriate amount of food (calories) and liquids to maintain body weight;
- •- Patients with surveillance colonoscopy defined as per ECCO guidelines;
- •¿ Patients with the following hematological and biochemical laboratory parameters obtained within 14 days prior to baseline:
- •o Hemoglobin > 9.0 g dL-1;
- •o Absolute neutrophil count >= 750 mm-3;
- •o Platelets >= 100,000 mm-3;
- •o Total serum creatinine <= 1.3 x ULN (upper limit of normal);
- •o Creatinine clearance > 50 mL min-1 by the Cockcroft-Gault equation within 60 days prior to baseline;
- •o Total serum bilirubin < 1.5 x ULN;
- •o Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 2 x ULN;
- •- Patients are able and willing to comply with study visits and procedures as per protocol;
- •- Patients should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures are performed;
- •- Patients should be affiliated to a social security regimen (for French sites only);
- •- Females and males receiving the study treatment and their partners
排除标准
- •Patients who meet any of the following exclusion criteria will be excluded from the study:
- •¿ Patients with Crohn's Disease (CD) or presence or history of fistula, indeterminate colitis (IC), infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis);
- •¿ History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or imminent colectomy, colonic malignancy;
- •¿ History or current evidence of colonic dysplasia or adenomatous colonic polyps. Patient with severe gastrointestinal complications; e.g., short bowel syndromes, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation;
- •¿ History of more than one episode of herpes zoster or a history (single episode) of disseminated zoster;
- •¿ Patients with known active infections at screening such as infected abdominal abscess, Clostridium difficile (stool antigen and toxin required), CMV, TB colitis and recent infectious hospitalization;
- •¿ Patients previously treated with ABX464;
- •¿ Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
- •¿ Acute, chronic or history of immunodeficiency or autoimmune disease;
- •¿ History of malignancy excluding patients considered cured (5 years disease free survivors);
- •¿ Serious illness requiring systemic treatment and/or hospitalization within 3 Weeks prior to baseline;
- •¿ Pregnant or breast-feeding women;
- •¿ Illicit drug or alcohol abuse or dependence;
- •¿ Use of any investigational or non-registered product within 3 months preceding baseline;
- •¿ Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
研究者
相似试验
进行中（未招募）
不适用
A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors - Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS)MedDRA version: 14.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersAtrial FibrillationEUCTR2010-019791-73-DESanofi-aventis recherche & développement10,800
进行中（未招募）
1 期
Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.Moderate to Severe Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856EUCTR2018-003558-26-CZABIVAX232
进行中（未招募）
不适用
A randomized, double blind, placebo controlled, parallel groups, pilot study to assess the effects of two new nail lacquers, cyclosporine 5% and calcipotriol 0.005%, in the treatment of nail psoriasis - NDail psoriasisMedDRA version: 9.1Level: LLTClassification code 10028703EUCTR2010-019706-16-ITPOLICHEM
进行中（未招募）
不适用
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5x10E7pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infectioHigh grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infectionMedDRA version: 9.1Level: LLTClassification code 10049701Term: Cervical intraepithelial neoplasia IIMedDRA version: 9.1Level: LLTClassification code 10049702Term: Cervical intraepithelial neoplasia IIIEUCTR2008-006946-24-DEF. Hoffmann-La Roche Ltd200
进行中（未招募）
不适用
A clinical study evaluating two different nail lacquers containing cyclosporine 5% and calcipotriol 0.005% in the treatment of nail psoriasis. A placebo (no active compound) will be used as control. Nor the investigator nor the patient will know the treatment applied.ail psoriasis of the nail matrix and / or the nail bed at fingernails (at least one should be affected)EUCTR2010-019706-16-LVPolichem SA75