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-PT
- Lead Sponsor
- Theravance Biopharma Ireland Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
Capable of providing informed consent, which must be obtained prior to
any study-related procedures.
1. One of the following:
a. Those who demonstrated persistent (as confirmed by endoscopy) loss
of response (no improvement approximately 6 to 8 weeks after meeting
loss of response criteria) or
b. two Clinical Flares after an episode (as confirmed by endoscopy) of loss of response during the Maintenance Study.
OR
c. Those who have completed the Maintenance Study (even if the subject
declined endoscopy during a clinical flare assessment during the
Maintenance Study of Protocol 0157) and have a confirmed clinical remission status (in remission or not in remission) with available results
2. 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.
3. All male subjects must agree to refrain from semen donation during
the study and for 7 days after the last dose of study drug.
4. 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 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 dysplasia that was not completely resected or high-grade
dysplasia detected during Protocol 0157; however, subjects with
adenomas with low grade dysplasia that have been completely resected
are eligible
5. Taking any medications/treatments 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 [e.g., developed unstable or
uncontrolled and clinically significant allergic (except for untreated,
asymptomatic, seasonal allergies), hematological, endocrine/metabolic,
coagulation, immunologic, pulmonary, cardiovascular, hepatic (except
hepatic steatohepatitis), GI (except UC), genitourinary, psychiatric,
oncologic thrombotic (e.g., deep vein thromboses (DVT) or pulmonary
embolism or neurological disease or other medical disorder before,
during or after 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.
10. Subject has had a live viral vaccine (e.g., MMR, varicella zoster,
herpes zoster, oral polio virus, FluMist®, attenuated typhoid fever
vaccine, attenuated rotavirus vaccine, yellow fever vaccine, or any
investigational live vaccine) within 4 weeks prior to Day 1 and/or is
unwilling or unable to avoid live viral vaccines during the Study and for 8
weeks following the last dose of study drug. Subject must be willing to avoid contact with any household member who has been vaccinated with
a live attenuated vaccine within 2 weeks after vaccination.
11. Are pregnant, lactating, breastfeeding or planning to become
pregnant during the Study or within 7 days after the last dose of Study
Drug
12. Within 4 weeks of Day 1, has [1] confirmed severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) infection (coronavirus disease
2019 [COVID-19]) (test positive), OR [2] suspected SARS-CoV-2
infection (clinical features without documented test results) unless has a
negative test for SARS-CoV-2 two weeks after resolution of symptoms
and remains asymptomatic until Day 1, OR [3] close contact with a
person with known or
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