A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Фаза 2/3 Идёт, набор закрыт NCT03466411

Заболевание	Crohn's Disease
Фаза	Фаза 2/3
Спонсор	Janssen Research & Development, LLC
Статус	Идёт, набор закрыт
Участники	1,409 участн.
Вмешательство	Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Guselkumab Dose 4, Guselkumab Dose 5
Дата начала	13.04.2018
Дата завершения	20.10.2023
Публикация результатов	7.05.2025

Кратко

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.

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

Baseline and Week 12 · Units on a scale

GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w	-143.7 ± 96.58 Units on a scale
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w	-139.2 ± 100.71 Units on a scale
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w	-159.8 ± 110.52 Units on a scale
GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w	-34.4 ± 104.85 Units on a scale

p-value	<0.001
Least Square (LS) Mean Difference	124.2 (95% CI 89.8–158.7)

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

Weeks 48 · Percentage of participants

GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w	54.8 Percentage of participants
GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w	49.0 Percentage of participants
GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w	11.8 Percentage of participants

p-value	<0.001
Adjusted treatment difference	38.1 (95% CI 27.3–48.9)

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

Weeks 48 · Percentage of participants

GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w	38.4 Percentage of participants
GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w	39.2 Percentage of participants
GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w	5.3 Percentage of participants

p-value	<0.001
Adjusted treatment difference	33.7 (95% CI 24.1–43.2)

Открыть в BENITIONS Открыть на ClinicalTrials.gov

Другие исследования по этому заболеванию

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Act — Janssen Research & Development, LLC
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn' — Janssen Research & Development, LLC
A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Partic — Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease — Celularity Incorporated
Loss of RESponse to Ustekinumab Treated by Dose Escalation — Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Par — Pfizer

Все исследования

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