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A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-003759-23-NL
Enrollment
210
Registered
2016-06-06
Start date
2016-11-03
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Crohn's Disease MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856

Interventions

Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Concentration unit: mg milligram

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subject must have completed Study M13-740 through Week 52. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11

Exclusion criteria

Exclusion criteria: • For any reason subject is considered by the investigator to be an unsuitable candidate • Female subject with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study. • Subject is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

Design outcomes

Primary

MeasureTime frame
Main Objective: To observe the long-term efficacy, safety, and tolerability of repeated administration of upadacitinib in subjects with Crohn's disease (CD) who completed Study M13-740.;Secondary Objective: Not applicable;Primary end point(s): •Proportion of subjects achieving Remission at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96 •Proportion of subjects in Remission at Week 0 who maintain remission at Months 12, 24, 36, 48, 60, 72, 84, and 96 •Proportion of subjects achieving Response at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96 ;Timepoint(s) of evaluation of this end point: Every 12 months—

Secondary

MeasureTime frame
Secondary end point(s): • Proportion of subjects in Remission, and hs-CRP < 5 mg/L, and fecal calprotectin < 250 µg/g at Week 0 (Week 52 of Study M13-740), Month 12, Month 24, Month 36, Month 48, Month 60, Month 72, Month 84 and Month 96. ;Timepoint(s) of evaluation of this end point: Every 12 months—

Countries

Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Netherlands, New Zealand, Norway, Slovakia, Spain, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Trials Contact

AbbVie Deutschland GmbH & Co. KG

global-clinical-trials@abbvie.com+4961117201520

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026