To Evaluate the Efficacy and Safety of Upadacitinib tablet in adults with moderately with severely active Ulcerative Colitis.
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2024/04/065534
- Lead Sponsor
- M/s. MSN Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult male or female subjects with age =18 years and = 65 years of age at the time of screening.
2.Subjects who are willing and able to sign informed consent approved by an Independent Ethics Committee and Institutional Review Board for participation in the study and willing to adhere to all protocol procedures.
3.Subjects with moderately to severely (as assessed by the modified Mayo score) active ulcerative colitis (confirmed endoscopically prior to baseline) who have had an inadequate response or intolerance to one or more TNF blockers.
4.Male or female subjects of child-bearing potential must agree to use medically acceptable forms of contraception during the study.
5.Subject with a negative test for Tuberculosis with Mantoux Test.
1. Subject with history of hypersensitivity to investigational products or to any of the excipient.
2. Participant with current diagnosis of Crohns disease or diagnosis of indeterminate colitis
3. Current diagnosis of fulminant colitis and or toxic megacolon
4. Known active bacterial, viral, fungal, mycobacterial, or other infection including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds.
5. Total white blood cell count less than 2,500- µL, absolute neutrophil count less than 1,500-µL platelet count less than 100,000-µL absolute lymphocyte count less than 800-µL and hemoglobin less than 10 g-dL.
6. Renal system: estimated glomerular filtration rate eGFR less than40 mL-minute-1.73 m2.
7. Subject has active TB or meets TB exclusionary parameters
8. Receipt of any live vaccine within 4 weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 4 weeks after the last dose of study drug.
9. Subjects with medical history of Oncological Conditions since last 2 years
10. History of clinically significant drug or alcohol abuse within the last 6 months per Investigators judgment.
11. History of moderate to severe congestive heart failure New York Heart Association class III or IV
12. History of myocardial infarction, coronary stenting or CVA within 6 months prior to Screening.
13. Uncontrolled hypertension as defined by a persistent systolic blood pressure BP greater than 160 mmHg or diastolic BP greater than 100 mmHg. For subjects with known hypertension, the subjects BP must be stable for at least 4 weeks on current, stable anti-hypertensive medications.
14. Clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate QTc using Fridericias correction formula QTcF greater than 450 msec males or greater than 470 msec - females.
15. Infection requiring treatment with parenteral anti-infectives within 30 days, or oral anti-infectives within 14 days prior the first dose of study drug.
16. Subjects with clinically significant impaired hepatic function. SGOT & SGPT more than 3X the UNL and-or Total bilirubin more than 1.5X the UNL.
17. Subjects with suspected signs and symptoms of COVID-19-confirmed novel coronavirus infection or with a recent history of travel-contact with any COVID-19 positive subject-isolation-quarantine in the last 14 days
18. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
19. Females who are not ready to use acceptable contraceptive methods during the course of study.
20. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
21. Subjects with history of HIV and or Hepatitis B and or Hepatitis C.
22. Suspected inability or unwillingness to comply with the study procedures.
23. Subjects with clinically significant disorders that, in the opinion of the investigator, would result in jeopardizing subjects safety and efficacy of the drug.
24. Subject with a positive test for Tuberculosis with QuantiFERON-TB Gold test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving clinical remission at end of 8 weeks using modified Mayo score <br/ ><br>Proportion of subjects achieving Endoscopic improvement at the end of study.Timepoint: Proportion of subjects achieving clinical remission at end of study using modified Mayo score consists of 3 components <br/ ><br>Visit 1. Screening Visit Screening -14 days <br/ ><br>Visit 2. Randomization Baseline Visit Day 0 <br/ ><br>Visit 3. Week 1 or Day 7 pulse 2days window <br/ ><br>Visit 4. Week 4 or Day 28 pulse 2 days window <br/ ><br>Visit 5. Week 8 or Day 56 pulse 2 days window <br/ ><br>Visit 6. Week 12 or Day 84 pulse 2 days window <br/ ><br>Visit 7. Week 16 or Day 112 End of study pulse 2 days window <br/ ><br>
- Secondary Outcome Measures
Name Time Method Proportion of subjects achieving clinical remission at end of 8 weeks using modified Mayo score <br/ ><br>Proportion of subjects achieving Endoscopic improvement at the end of study.Timepoint: Proportion of subjects achieving clinical remission at end of study using modified Mayo score consists of 3 components <br/ ><br>Visit 1. Screening Visit Screening -14 days <br/ ><br>Visit 2. Randomization Baseline Visit Day 0 <br/ ><br>Visit 3. Week 1 or Day 7 pulse 2days window <br/ ><br>Visit 4. Week 4 or Day 28 pulse 2 days window <br/ ><br>Visit 5. Week 8 or Day 56 pulse 2 days window <br/ ><br>Visit 6. Week 12 or Day 84 pulse 2 days window <br/ ><br>Visit 7. Week 16 or Day 112 End of study pulse 2 days window.