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Trial record 1 of 2 for:    TD-1473
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TD-1473 for Active Ulcerative Colitis (UC)

This study is currently recruiting participants.
Verified July 2017 by Theravance Biopharma R & D, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02818686
First Posted: June 30, 2016
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.
  Purpose
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.

Condition Intervention Phase
Ulcerative Colitis, Active Moderate Ulcerative Colitis, Active Severe Drug: TD-1473 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma R & D, Inc.:

Primary Outcome Measures:
  • To assess safety of TD-1473 administered for 28 days in subjects with active UC by assessing the number, severity, and type of adverse events, including changes in vital signs, physical examination, safety laboratory values, and ECGs [ Time Frame: Day 1 through Day 28 ]

Secondary Outcome Measures:
  • Cmax in plasma [ Time Frame: Day 1 and Day 14 ]
  • Tmax in plasma [ Time Frame: Day 1 and Day 14 ]
  • Area under curve (AUC) in plasma [ Time Frame: Day 1 and Day 14 ]
  • Ctrough in plasma [ Time Frame: Day 14 and Day 28 ]
  • To evaluate the effect of TD-1473 on C-reactive protein (CRP) [ Time Frame: Day 1 through Day 28 ]
  • To evaluate the effect of TD-1473 on fecal calprotectin [ Time Frame: Day 1 and Day 28 ]
  • To evaluate the change in partial Mayo score induced by TD-1473 treatment compared to placebo [ Time Frame: Day 1 and Day 28 ]

Estimated Enrollment: 40
Study Start Date: August 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TD-1473 low dose
10 subjects will be randomized to receive low-dose TD-1473 orally daily for 28 days
Drug: TD-1473
Experimental: TD-1473 mid dose
10 subjects will be randomized to receive mid-dose TD-1473 orally daily for 28 days
Drug: TD-1473
Experimental: TD-1473 high dose
10 subjects will be randomized to receive high-dose TD-1473 orally daily for 28 days
Drug: TD-1473
Placebo Comparator: Placebo
10 subjects will be randomized to receive placebo orally daily for 28 days
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818686


Contacts
Contact: Kit Chiu, MS, PhD 650-808-3926 kchiu@theravance.com

Locations
United States, Louisiana
Delta Research Partners, LLC. Recruiting
Monroe, Louisiana, United States, 71201
Contact: Melissa McCullars    318-807-0819    mmccullars@gastromds.com   
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Investigators
Study Director: Deanna Nguyen, MD Theravance Biopharma, US, Inc.
  More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT02818686     History of Changes
Other Study ID Numbers: 0144
2016-001633-27 ( EudraCT Number )
First Submitted: June 23, 2016
First Posted: June 30, 2016
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theravance Biopharma R & D, Inc.:
Ulcerative Colitis, Active Moderate and Severe

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases