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临床试验/NCT03466411
NCT03466411进行中（未招募）2 期

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Janssen Research & Development, LLC588 个研究点 分布在 5 个国家实际入组 1,409 人开始时间: 2018年4月13日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中（未招募）
入组人数
1,409
试验地点
588
主要终点
GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
研究概览研究设计入排标准研究组 & 干预措施方案终点试验结果相关文献研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

详细描述

This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
治疗
盲法
双盲 (受试者、研究者)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
  • Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
  • Have screening laboratory test results within the protocol specified parameters
  • A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
  • Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

排除标准

  • Current diagnosis of ulcerative colitis or indeterminate colitis
  • Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
  • Unstable doses of concomitant Crohn's disease therapy
  • Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
  • Any medical contraindications preventing study participation

研究组 & 干预措施

Phase 2 (GALAXI 1): Group 4 (Ustekinumab)

Active Comparator

Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE and continue to receive ustekinumab.

干预措施: Ustekinumab (Drug)

Phase 2 (GALAXI 1): Group 1 (Guselkumab)

Experimental

Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab.

干预措施: Guselkumab Dose 2 (Drug)

Phase 2 (GALAXI 1): Group 2 (Guselkumab)

Experimental

Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

干预措施: Guselkumab Dose 2 (Drug)

Phase 2 (GALAXI 1): Group 2 (Guselkumab)

Experimental

Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

干预措施: Guselkumab Dose 3 (Drug)

Phase 2 (GALAXI 1): Group 3 (Guselkumab)

Experimental

Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

干预措施: Guselkumab Dose 5 (Drug)

Phase 2 (GALAXI 1): Group 3 (Guselkumab)

Experimental

Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

干预措施: Guselkumab Dose 4 (Drug)

Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)

Experimental

Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

干预措施: Ustekinumab (Drug)

Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)

Experimental

Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

干预措施: Placebo (Drug)

Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)

Experimental

Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

干预措施: Guselkumab (Drug)

Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)

Experimental

Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

干预措施: Placebo (Drug)

Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)

Experimental

Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

干预措施: Ustekinumab (Drug)

Phase 2 (GALAXI 1): Group 1 (Guselkumab)

Experimental

Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab.

干预措施: Guselkumab Dose 1 (Drug)

Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)

Active Comparator

Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE phase and continue to receive ustekinumab.

干预措施: Ustekinumab (Drug)

方案终点

主要结局

GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12

时间窗: Baseline and Week 12

The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity. Baseline was defined as the last observation prior to or at the date of the first study intervention.

Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

时间窗: Weeks 48

Clinical response was defined as a decrease from baseline (BL) in CDAI score greater than or equal to (\>=) 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

时间窗: Weeks 48

CR: decrease from BL in CDAI score \>=100/\<150. ER: \>=50% improvement from BL in SES-CD score/SES-CD score \<=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence \& size of ulcer, extent of ulcerated surface, extent of affected surface, presence \& type of narrowing) across 5 ileocolonic segments (ileum; right, left \& transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.

Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

时间窗: Weeks 48

Clinical response was defined as a decrease from baseline in CDAI score \>= 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

时间窗: Weeks 48

CR: decrease from BL in CDAI score \>=100/\<150. ER: \>=50% improvement from BL in SES-CD score/SES-CD score \<=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence \& size of ulcer, extent of ulcerated surface, extent of affected surface, presence \& type of narrowing) across 5 ileocolonic segments (ileum; right, left \& transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.

Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12

时间窗: Week 12

Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12

时间窗: Week 12

Endoscopic response was defined as \>=50% improvement from baseline in SES-CD score or SES-CD score \<=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12

时间窗: Week 12

Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12

时间窗: Week 12

Endoscopic response was defined as \>=50% improvement from baseline in SES-CD score or SES-CD score \<=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

次要结局

  • Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Remission at Week 48(At Week 48)
  • Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48(At Week 48)
  • Regional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48(At Week 48)
  • Regional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48(At Week 48)
  • GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12(At Week 12)
  • GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12(At Week 12)
  • Global: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4(At Week 4)
  • Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12(At Week 12)
  • Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12(At Week 12)
  • Global: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12(At Week 12)
  • Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12(At Week 12)
  • Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12(At Week 12)
  • Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48(At Week 48)
  • Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Endoscopic Remission at Week 48(At Week 48)
  • Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48(At Week 48)
  • Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48(At Week 48)
  • Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48(At Week 48)
  • Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48(At Week 48)
  • Global: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48(At Week 48)
  • Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48(At Week 48)
  • Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48(At Week 48)
  • Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12(At Week 12)
  • Regional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12(At Week 12)
  • Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12(At Week 12)
  • Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48(At Week 48)
  • Regional: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission at Week 48 and Endoscopic Response at Week 48(At Week 48)
  • GALAXI 1: Percentage of Participants With Clinical Remission at Week 12(At Week 12)
  • GALAXI 1: Percentage of Participants With Clinical Response at Week 12(At Week 12)
  • GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12(At Week 12)

试验结果

结果已于 2025-05-07 在 ClinicalTrials.gov 公示。 在 ClinicalTrials.gov 查看

受试者流程

入组 1409 人 · 完成 1286 人

主要终点

GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12

Units on a scale · Standard Deviation · 时间窗: Baseline and Week 12

GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w （n=58）GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w （n=62）GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w （n=60）GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w （n=60）
-143.7 (96.58)-139.2 (100.71)-159.8 (110.52)-34.4 (104.85)

The primary efficacy analysis set consisted of randomized participants who received at least 1 dose of study intervention (including a partial dose), except for those participants whose induction dosing was discontinued as a result of the urgent safety measure. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. This outcome measure was planned to be collected and analyzed for specified arms only.

Least Square (LS) Mean Difference 124.2 · 95% 置信区间 89.8–158.7 · p = <0.001 · Mixed Model for Repeated Measure

LS Mean Difference 102.7 · 95% 置信区间 68.5–136.9 · p = <0.001 · Mixed Model for Repeated Measure

LS Mean Difference 108.7 · 95% 置信区间 73.9–143.5 · p = <0.001 · Mixed Model for Repeated Measure

Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

Percentage of participants · 时间窗: Weeks 48

Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48
GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w （n=146）GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w （n=143）GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w （n=76）
54.849.011.8

The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the simple endoscopic score for crohn's disease (SES-CD) eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

Adjusted treatment difference 38.1 · 95% 置信区间 27.3–48.9 · p = <0.001 · Mantel Haenszel

Adjusted treatment difference 42.8 · 95% 置信区间 31.6–53.9 · p = <0.001 · Mantel Haenszel

Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

Percentage of participants · 时间窗: Weeks 48

Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48
GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w （n=146）GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w （n=143）GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w （n=76）
38.439.25.3

The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

Adjusted treatment difference 33.7 · 95% 置信区间 24.1–43.2 · p = <0.001 · Mantel Haenszel

Adjusted treatment difference 32.9 · 95% 置信区间 23.5–42.4 · p = <0.001 · Mantel Haenszel

Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

Percentage of participants · 时间窗: Weeks 48

Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48
GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w （n=150）GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w （n=143）GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w （n=72）
48.046.912.5

The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

Adjusted treatment difference 34.2 · 95% 置信区间 23.2–45.3 · p = <0.001 · Mantel Haenszel

Adjusted treatment difference 35 · 95% 置信区间 23.5–46.5 · p = <0.001 · Mantel Haenszel

Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

Percentage of participants · 时间窗: Weeks 48

Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48
GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w （n=150）GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w （n=143）GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w （n=72）
36.033.65.6

The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

Adjusted treatment difference 27.9 · 95% 置信区间 18.7–37.1 · p = <0.001 · Mantel Haenszel

Adjusted treatment difference 30.8 · 95% 置信区间 21.3–40.3 · p = <0.001 · Mantel Haenszel

Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12

Percentage of participants · 时间窗: Week 12

Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12
GALAXI 2 Placebo (From Group 4) （n=76）GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2) （n=289）
22.447.1

Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 2 Groups 1 and 2, and for participants who received placebo in GALAXI 2 Group 4.

Adjusted treatment difference 25.1 · 95% 置信区间 14.1–36.2 · p = <0.001 · Mantel Haenszel

Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12

Percentage of participants · 时间窗: Week 12

Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12
GALAXI 2 Placebo (From Group 4) （n=76）GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2) （n=289）
10.537.7

Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 2 Groups 1 and 2, and for participants who received placebo in GALAXI 2 Group 4.

Adjusted treatment difference 27.7 · 95% 置信区间 19.3–36.1 · p = <0.001 · Mantel Haenszel

Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12

Percentage of participants · 时间窗: Week 12

Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12
GALAXI 3 Placebo (From Group 4) （n=72）GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2) （n=293）
15.347.1

Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 3 Groups 1 and 2, and for participants who received placebo in GALAXI 3 Group 4.

Adjusted treatment difference 31.2 · 95% 置信区间 21.1–41.3 · p = <0.001 · Mantel Haenszel

Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12

Percentage of participants · 时间窗: Week 12

Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12
GALAXI 3 Placebo (From Group 4) （n=72）GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2) （n=293）
13.936.2

Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 3 Groups 1 and 2, and for participants who received placebo in GALAXI 3 Group 4.

Adjusted treatment difference 22.1 · 95% 置信区间 12.2–31.9 · p = <0.001 · Mantel Haenszel

安全性

安全性
组别严重不良事件死亡
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w5 / 730 / 73
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w5 / 730 / 73
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w6 / 730 / 73
GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w9 / 710 / 71
GALAXI 1 (Group 5) Placebo q4w6 / 700 / 70
GALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w0 / 430 / 43
GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w6 / 1480 / 148
GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w19 / 1480 / 149
GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w18 / 1500 / 150
GALAXI 2 (Group 4) Placebo q4w6 / 770 / 77
GALAXI 2 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w3 / 490 / 49
GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w15 / 1510 / 151
GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w13 / 1480 / 148
GALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w17 / 1500 / 150
GALAXI 3 (Group 4) Placebo q4w10 / 760 / 76
GALAXI 3 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w6 / 510 / 51
最常见的严重不良事件（人数）
最常见的严重不良事件（人数）
事件GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4wGALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4wGALAXI 2 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4wGALAXI 3 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Crohn's Disease0 / 730 / 730 / 733 / 711 / 700 / 430 / 1485 / 1483 / 1503 / 771 / 493 / 1514 / 1481 / 1506 / 762 / 51
Abdominal Pain0 / 730 / 730 / 730 / 710 / 700 / 430 / 1481 / 1480 / 1501 / 770 / 490 / 1510 / 1483 / 1501 / 760 / 51
Small Intestinal Obstruction0 / 730 / 731 / 731 / 710 / 700 / 430 / 1480 / 1480 / 1500 / 770 / 493 / 1511 / 1481 / 1500 / 760 / 51
Anaemia0 / 731 / 730 / 730 / 711 / 700 / 430 / 1480 / 1482 / 1500 / 770 / 490 / 1510 / 1481 / 1500 / 760 / 51
Anal Fistula0 / 730 / 730 / 730 / 710 / 700 / 430 / 1481 / 1480 / 1500 / 770 / 491 / 1510 / 1480 / 1502 / 760 / 51
Intestinal Obstruction0 / 730 / 730 / 730 / 710 / 700 / 431 / 1481 / 1480 / 1500 / 770 / 492 / 1511 / 1482 / 1501 / 761 / 51
Intestinal Perforation0 / 730 / 730 / 730 / 710 / 700 / 430 / 1480 / 1480 / 1500 / 770 / 490 / 1511 / 1482 / 1500 / 760 / 51
Abdominal Abscess0 / 730 / 730 / 730 / 710 / 700 / 430 / 1480 / 1482 / 1500 / 770 / 490 / 1510 / 1480 / 1500 / 761 / 51
Abdominal Sepsis0 / 730 / 730 / 730 / 710 / 700 / 430 / 1480 / 1480 / 1500 / 770 / 490 / 1510 / 1482 / 1500 / 760 / 51
Abscess Intestinal0 / 730 / 730 / 730 / 710 / 700 / 431 / 1480 / 1482 / 1500 / 770 / 490 / 1510 / 1480 / 1500 / 760 / 51

数值为申办方在 ClinicalTrials.gov 公示的原始数据，未经重新计算；括号内为公示的离散度（如 95% 置信区间）。

相关文献

  • 相关文献（PubMed 关联）Afzali A, Danese S, Panaccione R, Rubin DT, Sands BE, Reinisch W, Panes J, Van Rampelbergh R, Terry NA, Salese L, Vetter ML, Yee J, Corbett C, van Duijnhoven W, Hisamatsu T, Andrews JM, D'Haens GR; GALAXI 1 investigators. Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial. Inflamm Bowel Dis. 2026 May 1:izag055. doi: 10.1093/ibd/izag055. Online ahead of print. PubMed 42065683
  • 相关文献（PubMed 关联）Panaccione R, Feagan BG, Afzali A, Rubin DT, Reinisch W, Panes J, Danese S, Hisamatsu T, Terry NA, Salese L, Van Rampelbergh R, Sahoo A, Vetter ML, Yee J, Han C, Frustaci ME, Wan KYY, Yang Z, Johanns J, Andrews JM, D'Haens GR, Sands BE; GALAXI 2 & 3 Study Group. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025 Jul 26;406(10501):358-375. doi: 10.1016/S0140-6736(25)00681-6. Epub 2025 Jul 17. PubMed 40684778
  • 相关文献（PubMed 关联）Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4. PubMed 40357993
  • 相关文献（PubMed 关联）Danese S, Panaccione R, Feagan BG, Afzali A, Rubin DT, Sands BE, Reinisch W, Panes J, Sahoo A, Terry NA, Chan D, Han C, Frustaci ME, Yang Z, Sandborn WJ, Hisamatsu T, Andrews JM, D'Haens GR; GALAXI-1 Study Group. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):133-146. doi: 10.1016/S2468-1253(23)00318-7. Epub 2023 Dec 14. PubMed 38104569
  • 相关文献（PubMed 关联）Sandborn WJ, D'Haens GR, Reinisch W, Panes J, Chan D, Gonzalez S, Weisel K, Germinaro M, Frustaci ME, Yang Z, Adedokun OJ, Han C, Panaccione R, Hisamatsu T, Danese S, Rubin DT, Sands BE, Afzali A, Andrews JM, Feagan BG; GALAXI-1 Investigators. Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study. Gastroenterology. 2022 May;162(6):1650-1664.e8. doi: 10.1053/j.gastro.2022.01.047. Epub 2022 Feb 5. PubMed 35134323

研究者

申办方类型
企业
责任方
申办方

研究点 (588)

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标识符

NCT 编号
NCT03466411
其他研究编号
CR108387, CNTO1959CRD3001, 2017-002195-13, 2023-504736-18-00, 2023, 2017

日期

首次提交
(8年前)
首次发布
(8年前)
主要完成日期
(2年前)
研究完成日期
(明年)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
是
FDA 监管器械
否
是否有结果
是

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