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TD-1473 for Active Ulcerative Colitis (UC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02818686
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis, Active Moderate Ulcerative Colitis, Active Severe Drug: TD-1473 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : March 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Treatment-emergent Adverse Events (TEAE) [ Time Frame: Baseline to end of follow-up (a maximum of 42 days) ]
    Number of participants who experience one or more treatment-emergent Adverse Events (TEAE)

  2. Moderate or Severe Treatment-emergent Adverse Events (TEAE) [ Time Frame: Baseline to end of follow-up (a maximum of 42 days) ]
    Number of participants who experience one or more moderate or severe treatment-emergent Adverse Events (TEAE)

  3. Serious Treatment-emergent Adverse Events (TEAE) [ Time Frame: Baseline to end of follow-up (a maximum of 42 days) ]
    Number of participants who experience one or more serious treatment-emergent Adverse Events (TEAE)

  4. Clinical Laboratory Measurements [ Time Frame: Baseline to end of follow-up (a maximum of 42 days) ]
    Number of participants who experienced a Clinically Significant Clinical Laboratory Measurements

  5. Electrocardiogram [ Time Frame: Baseline to Day 14 ]
    Number of participants who experienced a Clinically Significant Electrocardiogram (ECG) Result

  6. Vital Signs [ Time Frame: Baseline to end of follow-up (a maximum of 42 days) ]
    Number of participants who experienced a Clinically Significant Vital Sign Measurement

  7. Cmax in plasma [ Time Frame: Day 1 and Day 14 ]
    Maximum Observed Plasma Concentration of TD-1473

  8. Tmax in plasma [ Time Frame: Day 1 and Day 14 ]
    Time to Reach Maximum Observed Plasma Concentration (Cmax) of TD-1473

  9. Tlast in plasma [ Time Frame: Day 1 and Day 14 ]
    Time to Last Quantifiable Concentration of TD-1473

  10. Ctrough in plasma [ Time Frame: Day 14 (Pre-dose) ]
    Trough Concentration of TD-1473

  11. AUC0-4 in plasma [ Time Frame: Day 1 and Day 14 ]
    Area Under the Concentration-time Curve from Time Zero to 4 hours Post-Dose of TD-1473

  12. Ctissue in plasma [ Time Frame: Day 28 ]
    Tissue Concentration of TD-1473


Secondary Outcome Measures :
  1. C-reactive protein (CRP) [ Time Frame: Baseline, Day 14 and Day 28 ]
    Mean Change in Serum C-reactive Protein (CRP)

  2. Fecal Calprotectin [ Time Frame: Baseline and Day 28 ]
    Mean Change in Fecal Calprotectin

  3. Partial Mayo score [ Time Frame: Baseline, Day 14 and Day 28 ]
    Mean Change in Partial Mayo Score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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


Locations
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United States, Arizona
Theravance Biopharma Investigational Site
Scottsdale, Arizona, United States, 85259
United States, Louisiana
Theravance Biopharma Investigational Site
Monroe, Louisiana, United States, 71201
United States, Tennessee
Theravance Biopharma Investigational Site
Hermitage, Tennessee, United States, 37076
United States, Texas
Theravance Biopharma Investigational Site
Houston, Texas, United States, 77004
Theravance Biopharma Investigational Site
San Antonio, Texas, United States, 78215
Georgia
Theravance Biopharma Investigational Site
Tbilisi, Georgia, 0141
Moldova, Republic of
Theravance Biopharma Investigational Site
Chisinau, Moldova, Republic of, MD-2025
Romania
Theravance Biopharma Investigational Site
Bucharest, Romania, 50152
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT02818686    
Other Study ID Numbers: 0144
2016-001633-27 ( EudraCT Number )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theravance Biopharma:
Ulcerative Colitis, Active Moderate and Severe
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases