Clinical Trials List
2016-10-10 - 2022-08-31
Phase III
Terminated6
ICD-10K51.90
Ulcerative colitis, unspecified, without complications
ICD-10K51
Ulcerative colitis
ICD-9556.9
Ulcerative colitis, unspecified
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ABT-494 for induction and maintenance therapy in subjects with moderately to severely active ulcerative colitis.
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Tsung-Yu Tsai Digestive System Department
- Chun-Lung Feng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 楊純豪 Division of Colorectal Surgery
- 林禎國 Division of Colorectal Surgery
- 姜正愷 Division of Colorectal Surgery
- Hung-Hsin Lin Division of Colorectal Surgery
- 張世慶 Division of Colorectal Surgery
- Jen-Jyn Lin 未分科
- 王煥昇 Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
1 Terminated
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chien-Yu Lu Digestive System Department
- Huang-Ming Hu Digestive System Department
- Fang-Jung Yu Yu Digestive System Department
- HSIANG YAO SHIH Digestive System Department
- Yu-Chung Su Digestive System Department
- I-CHEN WU Digestive System Department
- Chao-Hung Kuo Digestive System Department
- Wen-Hung Hsu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳薏如 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
Audit
None
Chairman/Global PI
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- YEN-HSUAN NI Digestive System Department
- 翁昭旼 Digestive System Department
- SHU-CHEN WEI Digestive System Department
- 謝銘鈞 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Substudy 1/Substudy 2: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score [ Time Frame: At Week 8 ]
Clinical remission per Adapted Mayo score.
Substudy 3: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score [ Time Frame: At Week 52 ]
Clinical remission per Adapted Mayo score.
Inclution Criteria
1. Male or female between 18 and 75 years of age at Baseline.
2. Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy
during the Screening Period, with exclusion of current infection, colonic dysplasia and/or
malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in
the assessment of the Investigator, must be available.
3. Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2
to 3 (confirmed by central reader).
4. Demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids,
immunosuppressants, and/or biologic therapies as defined below:
Corticosteroids
o Signs and symptoms of persistently active disease despite a history of at least one induction
regimen that included a dose equivalent to prednisone ≥ 40 mg/day orally for 3 to 4 weeks
or intravenously for 1 week, OR
o Unable to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally
without recurrent active disease, OR
o History of intolerance to corticosteroids (including, but not limited to Cushing's syndrome,
osteopenia/osteoporosis, hyperglycemia, insomnia, infection).
Immunosuppressants
o Signs and symptoms of persistently active disease despite a history of at least one 90-day
regimen of oral azathioprine (≥ 1.5 mg/kg/day; for subjects in Japan and China only:
≥ 1.0 mg/kg/day), 6-mercaptopurine (≥ 1 mg/kg/day; [for subjects in Japan and China
only: ≥ 0.6 mg/kg/day, rounded to the nearest available tablet of half tablet formulation]
or a documented 6-TGN level of 230 – 450 pmol/8 × 108
RBC or higher on the current
dosing regimen), injectable methotrexate (MTX ≥ 15 mg/week subcutaneous [SC] or
intramuscular), or tacrolimus (for subjects in Japan only: documented trough level of 5 –
10 ng/mL), OR
o History of intolerance to at least one immunosuppressant (including, but not limited to
nausea/vomiting, abdominal pain, pancreatitis, liver enzyme abnormalities, lymphopenia,
infection)
Note: Oral MTX use is allowed during the study, however prior or current use of oral MTX is
not sufficient for inclusion into the study unless these subjects were previously treated with
corticosteroids or immunosuppressants (azathioprine or 6-MP) and in the judgment of the
investigator have failed to respond to or could not tolerate their treatment.
Biologic agents for UC
o Signs and symptoms of persistently active disease despite a history of any of the following:
at least one 6-week induction regimen of infliximab (≥ 5 mg/kg intravenous [IV] at 0, 2
and 6 weeks),
at least one 4-week induction regimen of adalimumab (one 160 mg SC dose followed
by one 80 mg SC dose [or one 80 mg SC dose, in countries where this dosing regimen
is allowed] followed by one 40 mg SC dose at least 2 weeks apart),
at least one 2-week induction regimen of golimumab (one 200 mg SC dose followed by
one 100 mg SC dose at least 2 weeks apart),
at least one 6-week induction regimen of vedolizumab (300 mg IV at 0, 2 and
6 weeks), OR
o Recurrence of symptoms during scheduled maintenance dosing following prior clinical
benefit (discontinuation despite clinical benefit does not qualify), OR
o History of intolerance to at least one biologic agent (including, but not limited to infusionrelated reaction, demyelination, congestive heart failure [CHF], infection)
5. If female, subject must meet the criteria as stated in Section 5.2.4 of this protocol:
Contraception Recommendations and Pregnancy Testing.
6. Female subjects of childbearing potential must have a negative serum pregnancy test at the
Screening Visit and a negative urine pregnancy test at the Baseline Visit.
7. Male subjects must agree to follow protocol-specified pregnancy avoidance measures, including
refraining from donating sperm, for up to 90 days post last dose of study drug.
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, or mycophenolate mofetil within 30 days prior to Baseline.
5. Subject on 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 (e.g., tofacitinib, baricitinib, filgotinib).
8. Screening laboratory and other analyses show any of the following abnormal results:
Serum Aspartate Transaminase (AST) or Alanine Transaminase (ALT) > 1.5 × upper limit of
the reference range (ULN);
Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal
Disease (MDRD) formula < 40 mL/min/1.73 m2;
Total White Blood Cell (WBC) count < 3,000/µL;
Absolute neutrophil count (ANC) < 1,200/µL;
Platelet count < 100,000/µL;
Absolute lymphocytes count < 750/µL;
Hemoglobin < 9 g/dL.
The Estimated Number of Participants
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Taiwan
24 participants
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Global
844 participants
