2025-521683-35-00招募中4 期
GUselkumAb inteRvention and DIet evaluAtioN for pouchitis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the percentage of subjects with chronic or recurrent pouchitis achieving clinical remission (mPDAI score <5 and a reduction of overall score by ≥2 points from Baseline) after 16 weeks of treatment with guselkumab compared to 16 weeks of guselkumab and a dietary intervention
研究概览
简要总结
To describe the efficacy of guselkumab and the efficacy of the combination of guselkumab and a dietary intervention in improving the symptoms of patients with relapsing or refractory pouchitis.
研究设计
- 分配方式
- Randomized
- 主要目的
- Guselkumab intervention and diet evaluation for pouchitis
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Fluent in reading and speaking Dutch
- •Participants must be at least 18 years of age and younger than 80 years of age at the time of signing the Informed Consent Form (ICF)
- •Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner
- •The subject agrees to take ciprofloxacin (500 mg twice daily) on Day 1 and through Week 4, regardless of the previous treatment and to stop any previous antibiotic therapy on Day 1 of the study. For patients who did previously not tolerate quinolone therapy, an alternative antibiotic therapy between Day 1 and Week 4 with metronidazole (500 mg three times a day) will be allowed. (Additional courses of antibiotics will be allowed, as needed, for flares after Week 16.)
- •Participant with a proctocolectomy and IPAA for UC who developed chronic or recurrent pouchitis, defined as mPDAI score ≥5 and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either: (a) ≥2 recurrent episodes within 1 year prior to the screening visit, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) patients treated with maintenance antibiotic therapy taken continuously for four consecutive weeks before the screening visit and who are refractory to this antibiotic therapy, or (c) previously failure of another biologic therapy to treat chronic pouchitis.
排除标准
- •Crohn’s disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectious pouchitis, diverting ostomy or mechanical complications of the pouch
- •Chronic hepatitis B virus (HBV)* infection, chronic hepatitis C virus (HCV)** infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient (e.g., due to organtransplantation, history of common variable immunodeficiency, etc). * Subjects who are positive for hepatitis B virus surface antigen (HBsAg) will be excluded. For subjects who are negative for HBsAg but are positive for either surface antibodiesand/or core antibodies, HBV DNA polymerase chain reaction will be performed and if anytest result meets or exceeds detection sensitivity, the subject will be excluded.** If subject is HCV antibody positive, then a viral load test will be performed. If the viralload test is positive then the subject will be excluded.
- •Active severe infection (eg sepsis, cytomegalovirus, listeriosis or C. difficile)
- •The subject has allergies to and/or contraindications for ciprofloxacin and metronidazole
- •Participant has a history of malignancy or current malignancy, except for the following: adequately treated non-metastatic basal cell skin cancer, squamous cell skin cancer and cervical carcinoma in situ. Subjects with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy
- •Participant has serious hypersensitivity to guselkumab or to any of its excipients.
- •Any disorder or laboratory abnormalities which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- •Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- •Female who is pregnant, breast-feeding or intends to become pregnant before, during, or within 12 weeks after the last dose of study drug; or intending to donate ova during such time period or is of child-bearing potential and not using an adequate, highly effective contraceptive or males who want to make their partner pregnant or intend to donate sperm during the course of this study or for 12 weeks after the last dose of study drug
- •Participation in another interventional Trial with an investigational medicinal product (IMP) or device
- •Previous treatment with an anti-IL12/23 or an anti-IL23 antibody
- •Any investigational or approved biologic agent within 30 days of screening
- •Nonbiologic investigational therapy or JAK inhibitors within 30 days prior to screening
- •Active or untreated latent tuberculosis (TB). In case of a newly identified positive diagnostic TB test result (defined as a positive tuberculin skin test) , active TB has to be ruled out and appropriate treatment for latent TB has to be initiated for a minimum of 4 weeks prior to the first administration of study medication
研究组 & 干预措施
Guselkumab
Test
干预措施: Guselkumab (Drug)
结局指标
主要结局
the percentage of subjects with chronic or recurrent pouchitis achieving clinical remission (mPDAI score <5 and a reduction of overall score by ≥2 points from Baseline) after 16 weeks of treatment with guselkumab compared to 16 weeks of guselkumab and a dietary intervention
the percentage of subjects with chronic or recurrent pouchitis achieving clinical remission (mPDAI score <5 and a reduction of overall score by ≥2 points from Baseline) after 16 weeks of treatment with guselkumab compared to 16 weeks of guselkumab and a dietary intervention
次要结局
- The percentage of subjects achieving clinical remission (mPDAI score <5 and a reduction of overall score by ≥2 points from Baseline) after 48 weeks in both groups
- The percentage of subjects achieving antibiotic free clinical remission by week 16 and 48
- The percentage of subjects achieving partial response (reduction of mPDAI score by ≥2 points from Baseline) after 16 and 48 weeks in both groups
- Time to clinically relevant remission in both groups
- Change in mPDAI endoscopic subscore at Week 16 and 48 compared to Baseline in both groups
- Change in mPDAI histologic subscore at Week 16 and 48 compared to Baseline in both groups
- Change in total mPDAI score at Week 16 and 48 compared to Baseline in both groups
- The percentage of subjects achieving a (endoscopic proven) flare after initial response in both groups
- Changes in intestinal microbiota (metagenomic microbiota profiling) at Week 8, 16, 24, 32, 40 and 48 compared to Baseline in both groups
- Changes in IL-23p19 expression in the tissue at Week 16 and 48 compared to Baseline in both groups
- Association between IL-23p19 expression and response to therapy in both groups
- Compliance to the prescribed diet with food record and food frequency questionnaire in the group with the dietary intervention
- Safety of the prescribed diet in the group with the dietary intervention
- Tolerability of the prescribed diet with questionnaire in the group with the dietary intervention
- Time to relapse of pouchitis symptoms and number of relapses in both groups
- Change in CRP at Week 8, 16, 24, 32, 40 and 48 compared to Baseline in both groups
- Change in faecal calprotectin at Week 8, 16, 24, 32 and 48 compared to Baseline in both groups
- Evolution of guselkumab serum levels and anti-guselkumab antibodies between Baseline and Week 8, 16, 24, 32, 40 and 48 in both groups
- Correlation of guselkumab serum levels and anti-guselkumab antibodies with clinical, endoscopic and histological outcomes between Baseline and Week 8, 16, 24, 32, 40 and 48 in both groups
研究者
joao Sabino
Scientific
UZ Leuven
研究点 (1)
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