A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000642-62-GB

Enrollment

522

Registered

2018-10-25

Start date

2019-07-26

Completion date

Unknown

Last updated

2020-10-19

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

Conditions

Ulcerative Colitis MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

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 Other descriptive name: ABT-494 Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female between 16 and 75 years of age at Baseline. - Adolescent subjects at the age of 16 and 17 years old will be enrolled if approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects = 18 years old will be enrolled. - Adolescent subjects at the age of 16 and 17 years old must weigh = 40 kg and meet the definition of Tanner Stage 5 (refer to Appendix J) at the screening Visit. 2. Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy 3. Moderately to severely active ulcerative colitis 4. Demonstrated an inadequate response to, loss of response to, or intolerance to immunosuppressants, corticosteroids or biologic therapies 5. Negative pregnancy test for female subjects of childbearing potential Are the trial subjects under 18? yes 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 464 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 49

Exclusion criteria

Exclusion criteria: 1. Subject with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC). 2. Current diagnosis of fulminant colitis and/or toxic megacolon. 3. Subject with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. 4. Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline. 5. Subject who received azathioprine or 6-mercaptopurine within 10 days of Baseline. 6. Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period. 7. Subject with previous exposure to JAK inhibitor.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely active ulcerative colitis.;Secondary Objective: The secondary objectives of the study are to evaluate the efficacy of upadacitinib 45 mg QD comparing with placebo in ranked secondary endpoints of achieving endoscopic improvement, endoscopic remission, clinical response per Adapted Mayo Score, clinical response per Partial Adapted Mayo score, histologic-endoscopic mucosal improvement, no bowel urgency, no abdominal pain, histologic improvement, mucosal healing, and change in IBDQ total score and FACIT-F score.;Primary end point(s): The primary endpoint for Study M14-675 is the proportion of subjects who achieve clinical remission per Adapted Mayo score (defined as SFS = 1 and not greater than baseline, RBS of 0, and endoscopic sub score = 1) at Week 8. ;Timepoint(s) of evaluation of this end point: Part 1: Week 8 and Part 2: Week 16 (Extended Treatment Period; as applicable)	—

Measure

Time frame

Main Objective: The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely active ulcerative colitis.;Secondary Objective: The secondary objectives of the study are to evaluate the efficacy of upadacitinib 45 mg QD comparing with placebo in ranked secondary endpoints of achieving endoscopic improvement, endoscopic remission, clinical response per Adapted Mayo Score, clinical response per Partial Adapted Mayo score, histologic-endoscopic mucosal improvement, no bowel urgency, no abdominal pain, histologic improvement, mucosal healing, and change in IBDQ total score and FACIT-F score.;Primary end point(s): The primary endpoint for Study M14-675 is the proportion of subjects who achieve clinical remission per Adapted Mayo score (defined as SFS = 1 and not greater than baseline, RBS of 0, and endoscopic sub score = 1) at Week 8. ;Timepoint(s) of evaluation of this end point: Part 1: Week 8 and Part 2: Week 16 (Extended Treatment Period; as applicable)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Proportion of subjects with endoscopic improvement at Week 8 2. Proportion of subjects with endoscopic remission at Week 8 3. Proportion of subjects achieving clinical response per Adapted Mayo Score at Week 8 4. Proportion of subjects achieving clinical response per Partial Adapted Mayo score (defined as decrease from Baseline = 1 points and = 30% from Baseline, PLUS a decrease in RBS = 1 or an absolute RBS = 1 ) at Week 2 5. Proportion of subjects achieving histologic-endoscopic muscosal improvement at Week 8 6. Proportion of subjects who reported no bowel urgency at Week 8 7. Proportion of subjects who reported no abdominal pain at Week 8 8. Proportion of subjects who achieved histologic improvement at Week 8 9. Change from Baseline in IBDQ total score at Week 8 10. Proportion of subjects with mucosal healing at Week 8 11. Change from Baseline in FACIT-F score at Week 8 ;Timepoint(s) of evaluation of this end point: For points 1, 2, 3, 5, 6, 7, 8, 9, 10, 11 - week 8 For point 4 - Week 2	—

Measure

Time frame

Secondary end point(s): 1. Proportion of subjects with endoscopic improvement at Week 8 2. Proportion of subjects with endoscopic remission at Week 8 3. Proportion of subjects achieving clinical response per Adapted Mayo Score at Week 8 4. Proportion of subjects achieving clinical response per Partial Adapted Mayo score (defined as decrease from Baseline = 1 points and = 30% from Baseline, PLUS a decrease in RBS = 1 or an absolute RBS = 1 ) at Week 2 5. Proportion of subjects achieving histologic-endoscopic muscosal improvement at Week 8 6. Proportion of subjects who reported no bowel urgency at Week 8 7. Proportion of subjects who reported no abdominal pain at Week 8 8. Proportion of subjects who achieved histologic improvement at Week 8 9. Change from Baseline in IBDQ total score at Week 8 10. Proportion of subjects with mucosal healing at Week 8 11. Change from Baseline in FACIT-F score at Week 8 ;Timepoint(s) of evaluation of this end point: For points 1, 2, 3, 5, 6, 7, 8, 9, 10, 11 - week 8 For point 4 - Week 2

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Countries

Argentina, Australia, Austria, Belarus, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

eu-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

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