A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Matching Placebo for Upadacitinib — DRUG
  Matching placebo tablets
• Upadacitinib — DRUG
  Upadacitinib tablets

Study Details

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Key Dates

Start date

Nov 29, 2017

Status verified

Jul 2022

Primary completion

Aug 11, 2021

Completion

Aug 11, 2021

Study Design

Enrollment

624 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Part 1 (Double-blind): Placebo
  Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
• Experimental: Part 1 (Double-blind): Upadacitinib 45 mg
  Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
• Experimental: Part 2 (Open-label): Upadacitinib 45 mg
  Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
• Experimental: Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
  Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
• Experimental: Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
  Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
• Experimental: Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
  Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.

Primary Outcome Measure

Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12 [ Time Frame: Week 12 ]

Locations (119)

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