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A Multicenter, Randomized, Double-Blind, Placebo Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease Who Completed the Studies M14-431 or M14-433

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504951-29-00
Acronym
M14-430
Enrollment
229
Registered
2023-10-24
Start date
2017-07-27
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chron's Disease

Brief summary

Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with clinical remission per PROs at Week 52, Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with endoscopic response at Week 52, Sub-study 2: Occurrence rate of subjects with total hospitalizations (all-cause) over time with CD-related hospitalizations over time with surgeries over time with CD-related surgeries over time

Detailed description

Sub-study 1: Proportion of subjects with clinical remission per CDAI at Week 52, Sub-study 1: Proportion of subjects with endoscopic remission at Week 52, Sub-study 1: Change from Baseline in IBDQ at Week 52, Sub-study 1: Proportion of subjects achieving CR-100 at Week 52, Sub-study 1: Proportion of subjects without corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 (among all subjects), Sub-study 1: Proportion of subjects who discontinued corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 in subjects taking corticosteroids for CD at Baseline of induction, Sub-study 1: Proportion of subjects with clinical remission per PROs at Week 0 and Week 52, Sub-study 1: Change from Baseline in FACIT-F at Week 52, Sub-study 1: Proportion of subjects with clinical remission per PROs and endoscopic remission at Week 52, Sub-study 1: Proportion of subjects with CD-related hospitalizations during the 52 Week double-blind maintenance period, Sub-study 1: Proportion of subjects with resolution of EIMs at Week 52, in subjects with EIMs at Baseline, Sub-study 2: Proportion of subjects with clinical remission over time, Sub-study 2: Proportion of subjects with enhanced clinical response over time, Sub-study 2: Proportion of subjects with clinical response over time, Sub-study 2: Proportion of subjects with CR-100 over time, Sub-study 2: Proportion of subjects with endoscopic remission at Week 0, and every 48 weeks thereafter, Sub-study 2: Proportion of subjects with endoscopic response at Week 0, and every 48 weeks thereafter, Sub-study 2: Proportion of subjects without corticosteroid use for CD and achieve clinical remission over time, Sub-study 2: Time loss of enhanced clinical response, Sub-study 2: Time loss of clinical remission

Interventions

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with clinical remission per PROs at Week 52, Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with endoscopic response at Week 52, Sub-study 2: Occurrence rate of subjects with total hospitalizations (all-cause) over time with CD-related hospitalizations over time with surgeries over time with CD-related surgeries over time

Secondary

MeasureTime frame
Sub-study 1: Proportion of subjects with clinical remission per CDAI at Week 52, Sub-study 1: Proportion of subjects with endoscopic remission at Week 52, Sub-study 1: Change from Baseline in IBDQ at Week 52, Sub-study 1: Proportion of subjects achieving CR-100 at Week 52, Sub-study 1: Proportion of subjects without corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 (among all subjects), Sub-study 1: Proportion of subjects who discontinued corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 in subjects taking corticosteroids for CD at Baseline of induction, Sub-study 1: Proportion of subjects with clinical remission per PROs at Week 0 and Week 52, Sub-study 1: Change from Baseline in FACIT-F at Week 52, Sub-study 1: Proportion of subjects with clinical remission per PROs and endoscopic remission at Week 52, Sub-study 1: Proportion of subjects with CD-related hospital

Countries

Austria, Belgium, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026