EUCTR2018-001605-93-CZ进行中（未招募）1 期
A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding 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
- 255
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.Ability to provide informed consent prior to any study procedures and willing and able to attend all study visits.
- •2.Aged 18 to 80 years of age at the time of signing the informed consent.
- •3.Diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to Screening.
- •4.Evidence of UC extending proximal to the rectum (= 15 cm of involved colon).
- •5.Moderately to severely active UC as defined by (5a and 5b must be met):
- •(a) Stool Frequency and Rectal Bleeding subscores obtained during Screening on an eDiary.
- •i. Average daily mMS Stool Frequency subscore = 1 AND
- •ii. Average daily mMS Rectal Bleeding subscore = 1
- •(b) Modified Mayo endoscopic subscore of = 2 based on a full colonoscopy within 14 days prior to initial IRT randomization.
- •6.Participant had an inadequate response or intolerance to intervention with conventional treatment (oral aminosalicylates, oral CS, azathioprine, methotrexate, or 6 mercaptopurine) or prior biological treatment or demonstrated CS dependence for the treatment of UC. For participants who have previously used biological treatment, a participant may have failed up to 3 biologics that include up to 2 different mechanisms of action.
- •7.Where applicable, participants taking any of the following medications must be at a stable dose or discontinued:
- •(a) Oral 5-aminosalicylates must be at a stable dose for 2 weeks prior to the screening colonoscopy.
- •(b) Oral prednisone up to 25 mg/day or equivalent, must be at a stable dose for 2 weeks prior to the Screening colonoscopy and kept stable until the Week 10 assessment.
- •(c) Oral budesonide up to 9 mg/day, must be at a stable dose for 2 weeks prior to the Screening colonoscopy and kept stable until the Week 10 assessment.
- •(d) Topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids should be discontinued within 2 weeks prior to Screening colonoscopy. Rectal therapies should not be restarted after the Screening colonoscopy.
- •(e) An immunomodulator: participants must have been on treatment for a minimum of 8 weeks and must be kept at stable doses as below:
- •i. Azathioprine, must be at a stable dose for 4 weeks prior to Screening, OR
- •ii. 6-mercaptopurine, must be at a stable dose for 4 weeks prior to Screening, OR
- •iii. Methotrexate, must be at a stable dose for 4 weeks prior to Screening.
- •8.Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from randomization throughout the study duration and for at least 18 weeks after last dose of study intervention
- •9.Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
- •10.Non sterilized males who are sexually active with a female partner of childbearing potential should use condoms during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks.
- •11.No known history of active TB or latent TB without completion of appropriate intervention and negative QFT-TB during Screening.
- •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 range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1.Participant has UC limited to the rectum (ie, not beyond 15 cm of the anal verge).
- •2.Current diagnosis of fulminant colitis, a diagnosis of CD or indeterminate colitis, presence or history of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or untreated bile acid malabsorption. Participants with a history of toxic megacolon within 12 months of Screening are excluded.
- •3.History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, ileostomy, or other prior colonic resection, or need for surgical intervention for control of UC anticipated within 6 months.
- •4.Participant has received the following treatment:
- •(a) Infliximab: within 8 weeks prior to randomization.
- •(b) Adalimumab, certolizumab pegol, or golimumab: within 8 weeks prior to randomization.
- •(c) Vedolizumab or ustekinumab within 12 weeks of randomization.
- •(d) Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to randomization.
- •(e) Fecal microbiota transplantation: within 8 weeks prior to randomization.
- •5.Removed as part of Amd.5
- •6. Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23 (risankizumab, mirikizumab, guselkumab, tildrakizumab).
- •7.Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy.
- •8.Participant received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening.
- •9.Participants who received IV or intramuscular steroids within 2 weeks prior to Screening.
- •10.Participant is currently enrolled in another investigational device or drug study, or is within 35 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study(s), or receiving other investigational agent(s).
- •11.Participant received a transfusion of blood, plasma, or platelets within 30 days prior to Screening.
- •12.Participant received a Bacille Calmette-Guérin vaccination within 12 months of randomization or any other live vaccine less than 4 weeks prior to randomization.
- •13.Participant has any of the following criteria related to infections:
- •(a) Evidence of a recent systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment.
- •(b) Any infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks of Screening.
- •(c) Cytomegalovirus or Epstein-Barr virus infection that has not resolved within 8 weeks prior to Screening.
- •(d) Clinically significant chronic infection that has not resolved within 8 weeks of Screening.
- •(e) Nonserious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with study medical monitor.
- •(f) Clinical evidence of or suspected to have an abscess during Screening.
- •(g) Any underlying condition that predisposes the participant to infections.
- •(h) Participant had previous allogenic bone marrow transplant or history of organ or cell-based transplantation.
- •(i) Clinically significant active infection or signs/symptoms of infection that has the potential to worsen with immunosuppressive therapy.
- •(j) Signs or symptoms of ongoing infection due to intestinal pathogens.
- •14.Participant has known or suspected history of chronic use of NSAIDs and/or opiates, drug, or alcohol abuse.
- •15.History of cancer with the following exceptions:
- •history of b
研究者
相似试验
进行中（未招募）
1 期
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitislcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2018-001605-93-DEAstraZeneca AB255
进行中（未招募）
1 期
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisEUCTR2018-001605-93-HUAstraZeneca AB255
进行中（未招募）
1 期
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitislcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2018-001605-93-ATAstraZeneca AB255
进行中（未招募）
2 期
Phase 2 Dose-finding UC StudyJPRN-jRCT2011210030Ageishi Yuji21
暂停
2 期
Phase 2 Dose-finding Ulcerative Colitis StudyCTRI/2019/10/021804ASTRAZENECA AB