2024-511458-32-00招募中3 期
A multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of filgotinib, with single arm induction and maintenance, in pediatric subjects (8 to <18 years of age) with moderately to severely active ulcerative colitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 42
- 主要终点
- Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS) at Week 10
研究概览
简要总结
To evaluate the efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with UC
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Subject must have a minimum BW of 15 kg
- •Subject: a. has documented diagnosis of UC with a minimum duration of 3 months, b. has mMCS of 5 to 9, and an MCS endoscopic score >=2, rectal bleeding >=1, and stool frequency >=1, c. has had an inadequate response, loss of response, intolerance, or has medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. This includes subjects who depend on corticosteroids to control their symptoms and who experience worsening of their disease when attempting to wean off corticosteroids.
- •Female or male subjects from 8 to <18 years of age, on the date of signing the ICF.
排除标准
- •Subject has a diagnosis of inflammatory bowel disease (IBD)-unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon
- •Subject has a history of colectomy or extensive small bowel resection.
- •Subject with psychological or cognitive difficulties that might interfere with study participation.
- •Subject has any previous exposure to a Janus kinase (JAK) inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib).
- •Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.
- •Subject has an active infection.
- •Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).
- •Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria).
研究组 & 干预措施
GLPG0634
Test
干预措施: GLPG0634 (Drug)
Jyseleca 100 mg film-coated tablets, Jyseleca 200 mg film-coated tablets
Test
干预措施: Jyseleca 100 mg film-coated tablets (Drug)
Jyseleca 100 mg film-coated tablets, Jyseleca 200 mg film-coated tablets
Test
干预措施: Jyseleca 200 mg film-coated tablets (Drug)
结局指标
主要结局
Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS) at Week 10
Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS) at Week 10
Proportion of subjects achieving clinical remission based on mMCS2 at Week 58
Proportion of subjects achieving clinical remission based on mMCS2 at Week 58
次要结局
- Proportion of subjects achieving endoscopic remission defined by Mayo endoscopic subscore of 0 at Week 58
- Incidence of treatment-emergent adverse events (TEAEs), adverse events of interest, and laboratory abnormalities through follow-up (Week 62)
- Change from baseline in body mass index (BMI) at Week 58
- Change from baseline in height velocity at Week 58
- Proportion of subjects achieving clinical remission defined by Pediatric Ulcerative Colitis Activity Index (PUCAI) <10 at Week 10
- Proportion of subjects achieving clinical remission defined by PUCAI <10 at Week 58
- Proportion of subjects achieving endoscopic remission defined by Mayo endoscopic subscore of 0 at Week 10
- Proportion of subjects achieving mMCS response defined as mMCS reduction by >=2 points and >=30% from induction baseline, with decrease in rectal bleeding subscore of >=1 or absolute rectal bleeding subscore of 0 or 1 at Week 10
- Proportion of subjects achieving MCS response defined as mMCS reduction by >=2 points and >=30% from induction baseline, with decrease in rectal bleeding subscore of >=1 or absolute rectal bleeding subscore of 0 or 1 at Week 58
- Proportion of subjects achieving 6-month corticosteroid-free mMCS remission at Week 58
- Change from baseline in TUMMY-UC score at Week 10 and Week 58
- Proportion of subjects with TUMMY-UC remission at Week 10 and Week 58
- Change from baseline in IMPACT-III score at Week 10 and Week 58
- PK parameters of filgotinib and its primary metabolite GS-829845 (including maximum observed plasma concentration at steady state [Cmax,ss], area under the plasma concentration-time curve over the dosing interval at steady state [AUC0-24,ss], and area under the plasma concentration-time curve over the dosing interval at steady state for the effective exposure [AUCeff,ss])
- Acceptability of the age-appropriate pediatric film-coated tablet formulation assessed by Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P)
- Acceptability of the adult tablet formulation assessed by POMAQ-P
研究者
Alexandra Mangili
Scientific
Alfasigma S.p.A.
研究点 (42)
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