A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)
- Conditions
- Moderately-to-severely active Ulcerative Colitis (UC)MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-002135-19-IT
- Lead Sponsor
- Theravance Biopharma Ireland Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
1. Capable of providing informed consent, which must be obtained prior to any study-related procedures.
2. One of the following:
a. Those who demonstrated persistent loss of response (no improvement 8 weeks after meeting loss of response criteria) or
b. two Clinical Flares after an episode of loss of response during the Maintenance Study. Loss of response must be documented by sigmoidoscopy/colonoscopy for the subject to be eligible. Subjects who declined the Clinical Flare Assessment #2 or endoscopic examination at the first Clinical Flare Assessment of Maintenance Study 0157 will not be eligible,
OR
c. Those who have completed the Maintenance Study and confirmation of clinical remission status results are available
3. During the study and for 7 days after receiving the last dose of the study drug, females of childbearing potential or men capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at Day 1.
4. All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
5. Must be able and willing to adhere to the study visit schedule and comply with other study requirements.
Are the trial subjects under 18? no
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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. Has current symptoms or signs suggestive of fulminant colitis, toxic megacolon, intestinal perforation
2. Has a high risk of requiring surgery for UC or any other type of major surgery (eg, requiring general anesthesia) during the study
3. Has been diagnosed during Protocol 0157 with Crohn’s disease, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, indeterminate colitis, or the subject has a current or past diagnosis of a fistula or abdominal abscess
4. Has endoscopic findings during Protocol 0157 of colitis-associated colonic dysplasia; however, subjects with spontaneous (non-colitis-associated) adenomas that have been completely resected are eligible
5. Taking any prohibited medications of exclusion as listed in the protocol currently or previously during Protocol 0157 Maintenance
6. Deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety or tolerability of the study drug (eg, developed unstable or uncontrolled and clinically significant condition/disease during Protocol 0157); or is unable or unwilling to comply with the study protocol
7. Develops hypersensitivity to excipients or contents of the study drug as noted in Protocol 0157.
8. Participating in or interested in participating in another investigational study (exception Protocol 0157)
9. Has clinically significant abnormalities in the results of laboratory evaluations at the most recent laboratory evaluation prior to LTS Day 1 visit as determined by the investigator, including:
• AST, ALT, or alkaline phosphatase = 2x the upper limit of normal (ULN)
• Total bilirubin > 2x ULN (unless diagnosis of Gilbert’s syndrome)
• Creatinine clearance as calculated by the Cockcroft-Gault formula < 30 mL/min
• Total white blood cell count (WBC) < 3 x 10^9/L
• Absolute neutrophil count < 1.5 x 10^9/L
• Absolute lymphocyte count < 0.8 x 10^9/L
• Hemoglobin < 8 g/dL
• Platelet count < 100 x 10^9/L.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method