TD-1473 for Active Ulcerative Colitis (UC)

• Register: ClinicalTrials.gov
• Last refreshed on: 11 October 2021
• Main ID: NCT02818686
• Date of registration: 23/06/2016
• Prospective Registration: Yes
• Primary sponsor: Theravance Biopharma
• Public title: TD-1473 for Active Ulcerative Colitis (UC)
• Scientific title: A Phase 1b Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Plasma Exposure of TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis
• Date of first enrolment: October 3, 2016
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02818686
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Georgia, Moldova, Republic of, Romania, United States

Contacts

• Name: Medical Monitor
• Affiliation: Theravance Biopharma

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has a history of ulcerative colitis diagnosis at least 3 months prior to screening

- Is intolerant, refractory, or only partially responsive to aminosalicylates,
corticosteroids, immunomodulators, or biologics. If subject is currently receiving an
oral aminosalicylate, he or she is eligible and can stay on that dose of
aminosalicylate provided the dose has been stable for at least 2 weeks prior to
screening. If the subject is currently receiving an oral corticosteroid, he or she is
eligible if the dose is equivalent to or less than prednisone 20 mg/day or budesonide
9 mg/day and stable for at least 2 weeks prior to screening sigmoidoscopy if the
subject has been on corticosteroids for more than 2 weeks.

- Has a rectal bleeding score = 1 and a bowel frequency score = 1 on the
patient-reported outcome 2 (PRO2) on screening sigmoidoscopy day and on Day 1 in
addition to a modified Mayo endoscopic subscore of = 2 during screening

- Women of childbearing potential must have a negative pregnancy test and either abstain
from sexual intercourse or use a highly effective method of birth control

- Willing and able to give informed consent

- Additional inclusion criteria apply

Exclusion Criteria:

- Has fulminant colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's
disease, history of colitis-associated colonic dysplasia, active peptic ulcer disease

- Medications of exclusion: a) azathioprine, 6-mercaptopurine, or methotrexate within
the 28 days prior to Day 1, b) adalimumab, infliximab, golimumab, etanercept, or
certolizumab within the 60 days prior to Day 1, c) intravenous corticosteroids within
the 14 days prior to Day 1, d) topical mesalamine or steroid (i.e., enemas or
suppositories) within the 14 days prior to Day 1, e) any prior exposure to
mycophenolic acid, tacrolimus, sirolimus, cyclosporine, natalizumab, rituximab,
efalizumab, ustekinumab, fingolimod, or thalidomide, f) NSAIDs on a daily basis, g)
tofacitinib within the 60 days prior to Day 1; h) vedolizumab within 120 days prior to
Day 1

- Has a current bacterial, parasitic, fungal, or viral infection

- Is positive for hepatitis A, B or C, HIV or tuberculosis

- Has clinically significant abnormalities in laboratory evaluations

- Participated in another clinical trial of an investigational drug (or medical device)
within 30 days prior to screening (or within 60 days prior to screening if
investigational drug was a biologic or another Janus kinase (JAK) inhibitor, or is
currently participating in another trial of an investigational drug (or medical
device)

- Use of prescription medications started or with a dose adjustment within 4 weeks prior
to study enrollment, or over-the-counter medications or supplements started or with a
dose adjustment within 2 weeks prior study enrollment. Anti-diarrheal medications are
allowed only if dose has been stable at least 2 weeks prior to study enrollment

- Additional exclusion criteria apply



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis, Active Severe

Ulcerative Colitis, Active Moderate

Intervention(s)

Drug: Placebo

Drug: TD-1473

Primary Outcome(s)

Cmax in plasma [Time Frame: Day 1 and Day 14]

Ctissue in plasma [Time Frame: Day 28]

Moderate or Severe Treatment-emergent Adverse Events (TEAE) [Time Frame: Baseline to end of follow-up (a maximum of 42 days)]

Ctrough in plasma [Time Frame: Day 14 (Pre-dose)]

Clinical Laboratory Measurements [Time Frame: Baseline to end of follow-up (a maximum of 42 days)]

Electrocardiogram [Time Frame: Baseline to Day 14]

Serious Treatment-emergent Adverse Events (TEAE) [Time Frame: Baseline to end of follow-up (a maximum of 42 days)]

Treatment-emergent Adverse Events (TEAE) [Time Frame: Baseline to end of follow-up (a maximum of 42 days)]

AUC0-4 in plasma [Time Frame: Day 1 and Day 14]

Tlast in plasma [Time Frame: Day 1 and Day 14]

Tmax in plasma [Time Frame: Day 1 and Day 14]

Vital Signs [Time Frame: Baseline to end of follow-up (a maximum of 42 days)]

Secondary Outcome(s)

Fecal Calprotectin [Time Frame: Baseline and Day 28]

C-reactive protein (CRP) [Time Frame: Baseline, Day 14 and Day 28]

Partial Mayo score [Time Frame: Baseline, Day 14 and Day 28]

Secondary ID(s)

0144

2016-001633-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors