A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment

Boehringer Ingelheim International GmbH0 个研究点目标入组 50 人开始时间: 2021年10月19日最近更新: 2024年8月26日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Boehringer Ingelheim International GmbH
入组人数: 50

研究概览入排标准研究者记录与标识符相似试验

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 patients.
•2. = 18 – = 75 years, at date of signing informed consent.
•3. Diagnosis of CD for at least 3 months prior to visit 1,as confirmed at
•any time in the past by endoscopy and/or radiology, and supported by histology.
•4. Elevated CRP (= 5 mg/L) OR elevated fecal calprotectin (= 250 µg/g)
•5. Symptomatic CD defined as = CDAI 150
•6. Presence of mucosal ulcers in at least one segment of the ileum or colon and a SESCD score = 7 (for patients with isolated ileitis =4), as assessed by ileo-colonoscopy and confirmed by central independent reviewer(s) before start of study treatment.
•7. Patients who are experienced to 1 or 2 TNF antagonists (i.e. biosimilars of a drug are counted as the originator drug, e.g. the switch from infliximab originator to CT-P13 will count as one TNF antagonist exposure) at a dose approved for CD. Patients may have stopped TNF antagonists treatment due to primary or secondary nonresponsiveness, intolerance (see definitions in Appendix 10.7), or for other reasons.
•8. May be receiving a therapeutic dose of the following:
•o Oral 5-ASA compounds must have been at a stable dose for at least 4 weeks prior to randomisation and must continue on this dose until week 12 and/or
•o Oral corticosteroids if indicated for treatment of CD must be at a prednisone equivalent dose of = 20 mg/day, or = 9 mg/day of budesonide, and have been at a stable dose for at least 2 weeks immediately prior to randomisation and must continue on this dose until week 12. [Allowed steroid treatments: Locally administered steroids as e.g. intra-articular, nasal inhalation or intra-ocular
•administration are allowed.] and/or
•o AZA, MP, or MTX, provided that dose has been stable for the 8 weeks immediately prior to randomisation and must continue on this dose until week 12.
•9. Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per International Councila on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information or in Section 4.2.2.3.
•10. Signed and dated written informed consent in accordance with ICH- Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
•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 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

排除标准

•1. Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to rand and are not anticipated to require surgery. Patients with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present based on investigator`s judgement
•2.Have comp. of CD such as strictures, stenosis, short bowel syndrome, or any other manifestation that might require surgery, or could preclude the use of SESCD/ CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with BI 706321
•3.Patient with an inflammatory bowel disease (IBD) diagnosis other than CD
•4. Have had any kind of bowel resection or diversion within 4 months or any other intraabdominal surgery within 3 months prior to visit 1. Patients with current ileostomy, colostomy, or ileorectal anastomosis are excluded
•5.Treatment with any non-biologic medication for IBD (tacrolimus or mycophenolate mofetil, systemic corticosteroids), other than those allowed per inclusion criteria, within 30 days prior to rand any biologic treatment with a TNF-alpha antagonist (adalimumab, infliximab, golimumab, certolizumab pegol) or vedolizumab within 4 weeks prior to rando. (If drug level testing for previously used biologic treatment confirms no detectable drug level before rand, patient can be enrolled despite not having completed 4 week from last treatment) any previous treatment with ustekinumab any previous treatment with an investigational non-biologic or biologic drug for CD any investigational drug for an indication other than CD during the course of the actual study and within 30 days or 5 half-lives (whichever is longer) prior to rand any prior exposure to rituximab within 1 year prior to randomisation
•6. Positive stool examination for C difficile (toxin A/B and GDH ag – test positive) or other intestinal pathogens <30 days prior to randomisation
•Re screening can be undertaken following documented successful treat, no sooner than 1 week after last intake of antimicrobial therapy. If stool examination for C. Diff is indeterminate (toxin A/B pos and GDH antigen negative or toxin A/B negative and GDH antigen pos), a reflex PCR test must be done to assess eligibility. A positive PCR test will lead to excl
•7. Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed
•8. Fecal transplant = 30 days prior to rand
•9. Increased risk of infectious complics (e.g. recent pyogenic inf, any congenital or acquired immunodeficiency (e.g. Human immunodeficiency virus), past organ or stem cell transplantation (with exception of a corneal transplant > 12 weeks prior to screening) or have ever received stem cell therapy (e.g., Prochymal). Prior treatment with a somatic cell therapy product (e.g., Alofisel) is not excluded, provided it was administered > 8 w prior to randomiz
•10. Live or attenuated vaccination within 4 weeks prior to rand
•11. Have received BCG vaccines = 1 year prior to randomisation
•12. Active or latent TB:
•- Patients with active tuberculosis are excluded.
•- Patients will be screened with Interferon Gamma Release Assay (IGRA) such as QuantiFERON or T spot, the patient may also be evaluated for the presence of TB with any additional test required by
•local practice. Patients with positive test results are excluded unless patient is known to have had a previous diagnosis of active or latent TB and has completed appropriate trea

研究者

发起方

Boehringer Ingelheim International GmbH

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