Struggling to manage your Ulcerative Colitis?
You may be eligible to participate in a clinical trial for a new treatment
Struggling to manage your Ulcerative Colitis? You may be eligible to participate in a clinical trial for a new treatment
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Ulcerative Colitis Clinical Trial in Zagreb Grad Zagreb
Struggling to manage your Ulcerative Colitis?
You may be eligible to participate in a clinical trial for a new treatment
Struggling to manage your Ulcerative Colitis? You may be eligible to participate in a clinical trial for a new treatment
Completed
Male & Female
16 - 75
Years old
Ulcerative Colitis is an inflammatory condition that affects the digestive track. For people with UC, it's symptoms can have a huge impact on their lives. There are several treatment options available for ulcerative colitis but they are not always effective for every patient. This clinical trial is evaluating a new treatment option for UC patients who have not responded well to other treatments.
Why should I participate?
All participants will receive study related treatments and procedures at no cost.
Who can participate?
Men and women who
-Are between the ages of 18-80
-Were diagnosed with Ulcerative Colitis
-Had an inadequate response to, loss of response to, or intolerance to corticosteroids, immunosuppressants, and/or biologic therapies
Details for the study
Brief Title
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary
This study comprises three sub-studies. The objective of sub-study 1 is to characterize the <br /> dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical <br /> remission in order to identify the induction dose of upadacitinib for further evaluation in <br /> sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of <br /> upadacitinib compared to placebo in inducing clinical remission in participants. The <br /> objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to <br /> placebo in achieving clinical remission in participants who had a response following <br /> induction with upadacitinib.
Treatments and/or Procedures
Updacitinib (ABT 494)
Tablet; Oral
Placebo
Tablet; Oral
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Substudy 1/Substudy 2: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score
Clinical remission per Adapted Mayo score.
Primary
Substudy 3: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score
Clinical remission per Adapted Mayo score.
Secondary
Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement
Histologic-endoscopic mucosal improvement defined by Endoscopic subscore and Geboes score.
Secondary
Substudy 3: Percentage Of Participants With Endoscopic Improvement Among Participants Who Had Endoscopic Improvement In Study M14-234 (Substudy 1 or 2) Or Study M14-675
Percentage of participants with endoscopic improvement among participants who had endoscopic improvement in Study M14-234 (Substudy 1 or 2) or Study M14-675.
Secondary
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo score And Were Corticosteroid Free ≥ 90 days
Percentage of participants who achieved clinical remission per Adapted Mayo score and were corticosteroid free ≥ 90 days among participants in clinical remission in the end of the induction treatment in Study M14-234 (Substudy 1 or 2) or M14-675.
Secondary
Substudy 3: Percentage Of Participants Who Maintain Clinical Remission Per Adapted Mayo Score Among Participants Who Received Clinical Remission Per Adapted Mayo Score in Study M14-234 (Substudy 1 or 2) Or M14-675
Percentage of participants who maintain clinical remission per Adapted Mayo score among participants who received clinical remission per Adapted Mayo score in Study M14-234 (Substudy 1 or 2) or M14-675.
Secondary
Substudy 3: Percentage Of Participants With Endoscopic Improvement
Endoscopic improvement defined by endoscopic subscore.
Secondary
Substudy 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire Score
The FACIT system is a collection of quality of life (QOL) questionnaires targeted to the management of cancer and other chronic illnesses.
Secondary
Substudy 2: Percentage Of Participants With Mucosal Healing
Percentage of participants with mucosal healing.
Secondary
Substudy 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Secondary
Substudy 3: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
The FACIT-F is a validated tool that measures an individual's level of fatigue during their usual daily activities.
Secondary
Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain
Percentage of participants who reported no abdominal pain.
Secondary
Substudy 3: Percentage Of Participants Who Maintain Clinical Response Per Adapted Mayo Score
Percentage of participants who maintain clinical response per Adapted Mayo score.
Secondary
Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency
Percentage of participants who reported no bowel urgency.
Secondary
Substudy 1: Percentage Of Participants With Endoscopic Improvement
Endoscopic improvement defined by endoscopic subscore.
Secondary
Substudy 3: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Secondary
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score
Percentage of participants achieving clinical response per Partial Mayo score.
Secondary
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score
Clinical response per Adapted Mayo.
Secondary
Substudy 2: Percentage Of Participants With Endoscopic Remission
Remission defined by endoscopic subscore.
Secondary
Substudy 2: Percentage Of Participants Who Report No Bowel Urgency
Percentage of participants who report no bowel urgency.
Secondary
Substudy 2: Percentage Of Participants With Endoscopic Improvement
Endoscopic improvement defined by endoscopic subscore.
Secondary
Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement
Histologic-endoscopic mucosal improvement defined by Endoscopic subscore and Geboes score.
Secondary
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement
Histologic improvement defined by Geboes score.
Secondary
Substudy 1: Change in Full Mayo Score
Change from baseline in Full Mayo score.
Secondary
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score
Percentage of participants achieving clinical response per Partial Mayo score.
Secondary
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score
Clinical response per Adapted Mayo.
Secondary
Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement
Histologic improvement defined by Geboes score.
Secondary
Substudy 3: Percentage Of Participants With Mucosal Healing
Percentage of participants with mucosal healing.
Secondary
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score
Clinical remission per Full Mayo score.
Secondary
Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain
Percentage of participants who reported no abdominal pain.
Secondary
Substudy 1: Percentage Of Participants With Endoscopic Remission
Remission defined by endoscopic subscore.
Secondary
Substudy 3: Percentage Of Participants With Endoscopic Remission
Percentage of participants with endoscopic remission.
Study Criteria
Inclusion Criteria: Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants >= 18 years old will be enrolled. Adolescents must weigh >= 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit. - 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. - Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader). - Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator. Note: Participants who have had inadequate response, loss of response to conventional therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease) and must meet criteria for inadequate response, loss of response or intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above. - If female, participant must meet the criteria for Contraception Recommendations. - Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing. Exclusion Criteria: - Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC). - Current diagnosis of fulminant colitis and/or toxic megacolon. - Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy. - Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline. - Participant on azathioprine or 6-mercaptopurine within 10 days of baseline. - Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period. - Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib). - Screening laboratory and other analyses show any abnormal results.