NL-OMON48184招募中2 期
A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn*s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 (CD)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Immunic AG
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •INDUCTION TREATMENT PHASE
- •1 Male or female patient, aged 18-80 years
- •2 Confirmed diagnosis of active luminal CD, at least 3 months before Screening
- •3 SES-CD score of at least 6, or of at least 4 in patients with isolated
- •ileitis (screening ileocolonoscopy and SES-CD score assessed by an in-dependent
- •central reader blinded to center and patient information)
- •4 At least one aphthous ulcerative lesion or more severe ulcer accessible by
- •ileocolonoscopy (as confirmed by an independent central blinded reader from
- •screening ileocolonoscopy)
- •5 Full CDAI score >=220 and <=450 at Screening Visit S1
- •6 Average daily very soft or liquid stool frequency score (based on the BSFS)
- •>=4.0 and/or AP-CDAI score >=2.0 at Screening Visit S1 (according to
- •retrospective data of the preceding 7 days)
- •7 Previous treatment failure defined as:
- •a Patient had an inadequate response with, lost response to, or was in-tolerant
- •to approved or experimental immunomodulators or biologics. A maximum of 3
- •treatment failures with biologic drugs i.e. anti-tumor necrosis factor alpha
- •antibodies, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, or
- •experimental antibodies, i.e. not approved for the use in CD or not approved
- •but in development for CD, is allowed; or
- •b Patient had an inadequate response to corticosteroids (a
- •corticosteroidrefractory patient is defined as having active disease despite
- •prednisolone up to 1 mg/kg/day for a period of 4 weeks), was intolerant to
- •corticosteroids, or is corticosteroid dependent (a corticosteroid-dependent
- •patient is defined as i) unable to reduce steroids below the equivalent of
- •prednisolone 10 mg/day [or budesonide be-low 3 mg/day] within 3 months of
- •starting steroids, without recurrent active disease, or ii) who has a relapse
- •within 3 months of stopping steroids.
- •8 Laboratory values: Neutrophil count >1500 cells/µL (>1.5 x 10^9
- •cells/L), platelet count
- •>=100 000/mm3 (>=100 x 10^9/L), serum creatinine <1.5 upper limit of normal
- •(ULN), total bilirubin, alanine aminotransferase, and aspartate
- •aminotransferase <1.5 ULN
- •9 Female patients
- •- must be of non-childbearing potential i.e. surgically sterilized
- •(hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks
- •before Screening Visit S1) or postmenopausal (where postmenopausal is defined
- •as no menses for 12 months without an alternative medical cause), or
- •- if of childbearing potential, must have a negative pregnancy test at
- •Screening Visit S1 (blood test) and at Day 0 before IMP administration (urine
- •test). They must agree not to attempt to become pregnant, not to donate ova and
- •to use a highly effective contraceptive method at the start of the trial (trial
- •consent), during treatment with IMU 838, and for at least 30 days after the
- •last intake of the IMP.
- •10 Male patients must agree not to father a child or to donate sperm starting
- •at Screening Visit S1, throughout the clinical trial and for 30 days after the
- •last intake of the IMP. Male patients must also
- •- abstain from sexual intercourse with a female partner (acceptable only if it
- •is the patient*s usual form of birth control/lifestyle choice), or use adequate
- •barrier contraception during treatment with the IMP and for at least 30 days
- 另有 2 项未显示
排除标准
- •GI CRITERIA
- •1 Diagnosis of ulcerative colitis, inflammatory bowel disease type
- •unclassified, ischemic colitis, microscopic colitis, radiation colitis or
- •diverticular disease-associated colitis
- •2 High likelihood of requiring bowel surgery during the 38 weeks of the BT
- •3 Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •4 Ileorectal anastomosis or ileal-pouch anal anastomosis
- •5 Celiac disease
- •6 Presence of intra-abdominal or perianal abscess that is undrained
- •7 History of subtotal colectomy or imminent need for colectomy (i.e. colectomy
- •is being planned)
- •8 Malabsorption or short-bowel syndrome
- •9 History of small bowel or colorectal cancer or gastrointestinal dysplasia
- •(with the exception of dysplasia in polyps that have been removed)INFECTIOUS
- •10 Clostridium difficile (C. difficile) infection
- •a Evidence of, or treatment for, C. difficile infection within 30 days before
- •randomization
- •b Positive C. difficile toxin B stool assay at Screening Visit S1
- •11 Treatment for intestinal pathogens other than C. difficile within 30 days
- •before randomization
- •12 Other chronic systemic infections
- •a History of chronic systemic infections including but not limited to
- •tuberculosis, HIV, HBV, or HCV, within 6 months before Screening Visit S1
- •b Positive interferon-gamma release assay for Mycobacterium tuberculosis at
- •Screening Visit S1
- •c Positive HBV surface antigen (HBsAg), hepatitis B core antibody (HBcAb),
- •positive HCV and/or HIV-antigen-antibody (HIV-Ag/Ab) test at Screening Visit S1
- •(even without detectable virus load in blood)
- •13 Any live vaccinations within 30 days before randomization except for the
- •influenza vaccineOTHER MEDICAL HISTORY AND CONCOMITANT DISEASE EXCLUSION
- •14 Known history of nephrolithiasis or underlying condition with a strong
- •association o nephrolithiasis, including hereditary hyperoxaluria or
- •hereditary hyperuricemia
- •15 Diagnosis or suspected liver function impairment which may cause, as
- •assessed by the investigator, a potential for fluctuating liver function tests
- •during this trial
- •16 Renal impairment i.e. eGFR <= 60 mL/min/1.73 m²
- •17 Serum uric acid levels at Screening Visit S1 >=1.2 x ULN (for women > 6.8
- •mg/dL, for men > 8.4 mg/dL)
- •18 History or clinical diagnosis of gout
- •19 Known or suspected Gilbert syndrome
- •20 Indirect (unconjugated) bilirubin >=1.2 x ULN (i.e. >=1.1 mg/dL) at Screening
- •21 Concurrent malignancy or prior malignancy within the previous 10 years
- •except for the following: adequately-treated non-melanoma skin cancer and
- •adequately-treated cervical cancerTHERAPY EXCLUSION CRITERIA
- •22 Use of any IMP within 8 weeks or 5 x the respective half-life before
- •randomization, whichever is longer
- •23 Use of the following medications within 2 weeks before randomization:
- •a Tofacitinib
- •b Methotrexate,
- 另有 8 项未显示
研究者
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