A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Фаза 2/3 Идёт, набор закрыт NCT04033445

Заболевание	Ulcerative Colitis
Фаза	Фаза 2/3
Спонсор	Janssen Research & Development, LLC
Статус	Идёт, набор закрыт
Участники	1,064 участн.
Вмешательство	Guselkumab
Дата начала	26.09.2019
Дата завершения	19.09.2023
Публикация результатов	18.11.2024

Кратко

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

At Week I-12 · Percentage of participants

IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	27.6 Percentage of participants
IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	61.4 Percentage of participants
IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8	60.7 Percentage of participants

p-value	< 0.001
Adjusted treatment difference	33.6 (95% CI 20.9–46.3)

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

At Week I-12 · Percentage of participants

IS-2: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	7.9 Percentage of participants
IS-2: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	22.6 Percentage of participants

p-value	< 0.001
Adjusted treatment difference	14.9 (95% CI 9.9–19.9)

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

At Week M-44 · Percentage of participants

MS: Randomized: Placebo SC Every 4 Weeks (q4w)	18.9 Percentage of participants
MS: Randomized: Guselkumab 100 mg SC q8w	45.2 Percentage of participants
MS: Randomized: Guselkumab 200 mg SC q4w	50.0 Percentage of participants

p-value	< 0.001
Adjusted treatment difference	25.2 (95% CI 16.4–33.9)

Открыть в BENITIONS Открыть на ClinicalTrials.gov

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Все исследования

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