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TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

Primary Purpose

Ulcerative Colitis (UC)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TD-1473 Dose A
TD-1473 Dose B
TD-1473 Dose C
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring TD-1473, Janus kinase inhibitor, JAK inhibitor, Inflammatory Bowel Disease, IBD, Ulcerative colitis, UC, Intestinal restriction, Gut-selective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be eligible for the study, subjects are required to enter the LTS Study within 14 days of exiting the Maintenance Study of Protocol 0157 and must meet all the following criteria:

  • Capable of providing informed consent, which must be obtained prior to any study related procedures.

  • One of the following:

    • Those who demonstrated persistent loss of response (no improvement 8 weeks after meeting loss of response criteria) OR
    • Two Clinical Flares after an episode of loss of response during the Maintenance Study OR
    • Those who have completed the Maintenance Study and confirmation of clinical remission status results are available
  • 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
  • All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
  • Must be able and willing to adhere to the study visit schedule and comply with other study requirements.

Exclusion Criteria:

  • Has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation
  • Likely to require surgery for UC or other major surgeries
  • Has previously received / is currently receiving prohibited medications
  • Has been diagnosed during Protocol 0157 with Crohn's disease, other colitis conditions or the subject has a current or past diagnosis of a fistula or abdominal abscess
  • Has endoscopic findings during Protocol 0157 of colitis-associated colonic dysplasia (with the exception of subjects with non-colitis associated spontaneous adenomas that have been completely resected)
  • Has clinically significant abnormalities in laboratory evaluations
  • Additional exclusion criteria apply

Sites / Locations

  • Theravance Biopharma Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Active Treatment TD-1473 with Dose A

Active Treatment TD-1473 with Dose B

Active Treatment TD-1473 with Dose C

Arm Description

Oral daily dose of TD-1473 for up to 156 weeks

Oral daily dose of TD-1473 for up to 156 weeks

Oral daily dose of TD-1473 for up to 156 weeks

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as any AE with a recorded start date on or after the date of the first dose of study drug up through 4 weeks after the last dose of study drug. Any clinically significant changes in laboratory safety tests, electrocardiograms (ECGs) and vital signs, were also recorded as TEAEs.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2019
Last Updated
October 10, 2022
Sponsor
Theravance Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT03920254
Brief Title
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
Official Title
A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
October 27, 2021 (Actual)
Study Completion Date
October 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157
Detailed Description
This is a multi-center, long-term safety study to evaluate the safety and tolerability of TD-1473 for up to 156 weeks (3 years) + 4 week follow-up in subjects with moderate to severe UC exiting the preceding Maintenance Study of Protocol 0157 (NCT03758443).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis (UC)
Keywords
TD-1473, Janus kinase inhibitor, JAK inhibitor, Inflammatory Bowel Disease, IBD, Ulcerative colitis, UC, Intestinal restriction, Gut-selective

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Long Term Safety (LTS)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment TD-1473 with Dose A
Arm Type
Experimental
Arm Description
Oral daily dose of TD-1473 for up to 156 weeks
Arm Title
Active Treatment TD-1473 with Dose B
Arm Type
Experimental
Arm Description
Oral daily dose of TD-1473 for up to 156 weeks
Arm Title
Active Treatment TD-1473 with Dose C
Arm Type
Experimental
Arm Description
Oral daily dose of TD-1473 for up to 156 weeks
Intervention Type
Drug
Intervention Name(s)
TD-1473 Dose A
Intervention Description
See Arm description
Intervention Type
Drug
Intervention Name(s)
TD-1473 Dose B
Intervention Description
See Arm description
Intervention Type
Drug
Intervention Name(s)
TD-1473 Dose C
Intervention Description
See Arm description
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Description
A TEAE was defined as any AE with a recorded start date on or after the date of the first dose of study drug up through 4 weeks after the last dose of study drug. Any clinically significant changes in laboratory safety tests, electrocardiograms (ECGs) and vital signs, were also recorded as TEAEs.
Time Frame
Day 1 up to 4 weeks after last dose of study drug (median treatment duration was: TD-1473 20 mg - 142 days; TD-1473 80 mg - 180.0 days; TD-1473 200 mg - 158 days)

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be eligible for the study, subjects are required to enter the LTS Study within 14 days of exiting the Maintenance Study of Protocol 0157 and must meet all the following criteria: Capable of providing informed consent, which must be obtained prior to any study related procedures. One of the following: Those who demonstrated persistent loss of response (no improvement 8 weeks after meeting loss of response criteria) OR Two Clinical Flares after an episode of loss of response during the Maintenance Study OR Those who have completed the Maintenance Study and confirmation of clinical remission status results are available 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 All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug. Must be able and willing to adhere to the study visit schedule and comply with other study requirements. Exclusion Criteria: Has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation Likely to require surgery for UC or other major surgeries Has previously received / is currently receiving prohibited medications Has been diagnosed during Protocol 0157 with Crohn's disease, other colitis conditions or the subject has a current or past diagnosis of a fistula or abdominal abscess Has endoscopic findings during Protocol 0157 of colitis-associated colonic dysplasia (with the exception of subjects with non-colitis associated spontaneous adenomas that have been completely resected) Has clinically significant abnormalities in laboratory evaluations Additional exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Theravance Biopharma Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92866
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
48519
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28215
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834-3761
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
27212
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Theravance Biopharma Investigational Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Theravance Biopharma Investigational Site
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Theravance Biopharma Investigational Site
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Theravance Biopharma Investigational Site
City
Sofia
State/Province
Sofiya
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Sofia
State/Province
Sofiya
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Sofia
State/Province
Sofiya
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site #2
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Ruse
ZIP/Postal Code
7005
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Sofia
ZIP/Postal Code
1712
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Stara Zagora
ZIP/Postal Code
6001
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Theravance Biopharma Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
Theravance Biopharma Investigational Site
City
Reims
State/Province
Champagne-ardenne
ZIP/Postal Code
51092
Country
France
Facility Name
Theravance Biopharma Investigational Site
City
Montpellier Cedex 5
State/Province
Languedoc-roussillon
ZIP/Postal Code
34295
Country
France
Facility Name
Theravance Biopharma Investigational Site
City
Vandœuvre-lès-Nancy Cedex
State/Province
Limousin
ZIP/Postal Code
54500
Country
France
Facility Name
Theravance Biopharma Investigational Site
City
Toulouse Cedex 9
State/Province
Midi-pyrenees
ZIP/Postal Code
31059
Country
France
Facility Name
Theravance Biopharma Investigational Site
City
Lille Cedex
State/Province
NORD Pas-de-calais
ZIP/Postal Code
59037
Country
France
Facility Name
Theravance Biopharma Investigational Site
City
Nantes
State/Province
PAYS DE LA Loire
ZIP/Postal Code
44000
Country
France
Facility Name
Theravance Biopharma Investigational Site
City
Amiens Cedex 1
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Facility Name
Theravance Biopharma Investigational Site
City
Pierre-Bénite
State/Province
Rhone-alpes
ZIP/Postal Code
69495
Country
France
Facility Name
Theravance Biopharma Investigational Site
City
Saint-Étienne
State/Province
Rhone-alpes
ZIP/Postal Code
42055
Country
France
Facility Name
Theravance Biopharma Investigational Site
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Facility Name
Theravance Biopharma Investigational Site
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Theravance Biopharma Investigational Site
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Theravance Biopharma Investigational Site
City
Heidelberg
State/Province
Baden Wuerttemberg
Country
Germany
Facility Name
Theravance Biopharma Investigational Site
City
Kiel
State/Province
Schleswig-holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Theravance Biopharma Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Theravance Biopharma Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Theravance Biopharma Investigational Site
City
Athens
State/Province
Attica
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Theravance Biopharma Investigational Site #2
City
Athens
State/Province
Attica
ZIP/Postal Code
11527
Country
Greece
Facility Name
Theravance Biopharma Investigational Site
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Theravance Biopharma Investigational Site
City
Patra
State/Province
Peloponnese
ZIP/Postal Code
265 04
Country
Greece
Facility Name
Theravance Biopharma Investigational Site
City
Szekesfehervar
State/Province
Fejer
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Theravance Biopharma Investigational Site
City
Debrecen
State/Province
Hajdu-bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Theravance Biopharma Investigational Site
City
Szekszárd
State/Province
Tolna
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Theravance Biopharma Investigational Site
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Theravance Biopharma Investigational Site
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Theravance Biopharma Investigational Site
City
Zerifin
State/Province
Rehoboth
ZIP/Postal Code
7030000
Country
Israel
Facility Name
Theravance Biopharma Investigational Site
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Theravance Biopharma Investigational Site
City
H̱olon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Theravance Biopharma Investigational Site
City
Jerusalem
ZIP/Postal Code
9362410
Country
Israel
Facility Name
Theravance Biopharma Investigational Site
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Theravance Biopharma Investigational Site
City
Pethah Tiqvā
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Theravance Biopharma Investigational Site
City
Reẖovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
Theravance Biopharma Investigational Site
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Theravance Biopharma Investigational Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Theravance Biopharma Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Theravance Biopharma Investigational Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Abiko
State/Province
Chiba
ZIP/Postal Code
270-1168
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
839-0809
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Ōgaki
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Isesaki
State/Province
Gunma
ZIP/Postal Code
372-0817
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Hiroshima
State/Province
Hiroshima-ken
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Hatsukaichi
State/Province
Hiroshima
ZIP/Postal Code
738-8503
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-8533
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
981-3213
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Suwa
State/Province
Nagano
ZIP/Postal Code
392-8510
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Ōita
State/Province
Oita
ZIP/Postal Code
870-0033
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Fujiidera
State/Province
Osaka
ZIP/Postal Code
583-0027
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Izumiotsu
State/Province
Osaka
ZIP/Postal Code
595-0027
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Ageo Shi
State/Province
Saitama Ken
ZIP/Postal Code
362-0075
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1114
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Kurobe
State/Province
Toyama
ZIP/Postal Code
938-8502
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Chiba
ZIP/Postal Code
260-0852
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Kumamoto
ZIP/Postal Code
860-0004
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Tokyo
ZIP/Postal Code
135-8577
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Tokyo
ZIP/Postal Code
136-0075
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Theravance Biopharma Investigational Site
City
Wŏnju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Theravance Biopharma Investigational Site
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Theravance Biopharma Investigational Site
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Theravance Biopharma Investigational Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Theravance Biopharma Investigational Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Theravance Biopharma Investigational Site
City
Seoul
ZIP/Postal Code
130702
Country
Korea, Republic of
Facility Name
Theravance Biopharma Investigational Site
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Theravance Biopharma Investigational Site
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
53-333
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
54-416
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Toruń
State/Province
Kujawsko-Pomorskie
ZIP/Postal Code
71-685
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Włocławek
State/Province
Kujawsko-Pomorskie
ZIP/Postal Code
87-800
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Ksawerów
State/Province
Lodzkie
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Łódź
State/Province
Lodzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Łódź
State/Province
Lodzkie
ZIP/Postal Code
91-034
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Piaseczno
State/Province
Mazowieckie
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-653
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Tychy
State/Province
Slaskie
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-369
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-685
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Świętokrzyskie
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Theravance Biopharma Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Theravance Biopharma Investigational Site
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Theravance Biopharma Investigational Site
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Facility Name
Theravance Biopharma Investigational Site
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Theravance Biopharma Investigational Site
City
Santa Maria Da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Theravance Biopharma Investigational Site
City
Senhora Da Hora
ZIP/Postal Code
4454-513
Country
Portugal
Facility Name
Theravance Biopharma Investigational Site
City
Viana Do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Facility Name
Theravance Biopharma Investigational Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434502
Country
Portugal
Facility Name
Theravance Biopharma Investigational Site
City
Timişoara
State/Province
Timis
ZIP/Postal Code
300002
Country
Romania
Facility Name
Theravance Biopharma Investigational Site
City
Bucuresti
ZIP/Postal Code
02025
Country
Romania
Facility Name
Theravance Biopharma Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Theravance Biopharma Investigational Site
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Theravance Biopharma Investigational Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Theravance Biopharma Investigational Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Theravance Biopharma Investigational Site
City
Subotica
ZIP/Postal Code
24000
Country
Serbia
Facility Name
Theravance Biopharma Investigational Site
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Theravance Biopharma Investigational Site
City
Prešov
State/Province
Prešovsky
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Theravance Biopharma Investigational Site
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Theravance Biopharma Investigational Site
City
Šahy
ZIP/Postal Code
936 01
Country
Slovakia
Facility Name
Theravance Biopharma Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Theravance Biopharma Investigational Site
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Theravance Biopharma Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Theravance Biopharma Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Theravance Biopharma Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Theravance Biopharma Investigational Site
City
Kaohsiung
State/Province
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Theravance Biopharma Investigational Site
City
Taichung
ZIP/Postal Code
40210
Country
Taiwan
Facility Name
Theravance Biopharma Investigational Site
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Theravance Biopharma Investigational Site
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Facility Name
Theravance Biopharma Investigational Site
City
Kiev
State/Province
Kiev City
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Kyiv
State/Province
Kiev
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Kyiv
State/Province
Kiev
ZIP/Postal Code
4107
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Kremenchuk
State/Province
Poltava
ZIP/Postal Code
39617
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Úzhgorod
State/Province
Transcarpathian
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Úzhgorod
State/Province
Transcarpathia
ZIP/Postal Code
88009
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site #2
City
Vinnytsia
State/Province
Vinnytsya
ZIP/Postal Code
20129
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Vinnytsia
State/Province
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Vinnytsia
State/Province
Vinnytsya
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site #2
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Ternopil
ZIP/Postal Code
46001
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Zaporizhzhya
ZIP/Postal Code
69096
Country
Ukraine
Facility Name
Theravance Biopharma Investigational Site
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

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