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

October 10, 2022 updated by: Theravance Biopharma

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Theravance Biopharma Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • Theravance Biopharma Investigational Site
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Theravance Biopharma Investigational Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Theravance Biopharma Investigational Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Theravance Biopharma Investigational Site
      • Pleven, Bulgaria, 5800
        • Theravance Biopharma Investigational Site #2
      • Plovdiv, Bulgaria, 4002
        • Theravance Biopharma Investigational Site
      • Plovdiv, Bulgaria, 4004
        • Theravance Biopharma Investigational Site
      • Ruse, Bulgaria, 7005
        • Theravance Biopharma Investigational Site
      • Sliven, Bulgaria, 8800
        • Theravance Biopharma Investigational Site
      • Sofia, Bulgaria, 1712
        • Theravance Biopharma Investigational Site
      • Stara Zagora, Bulgaria, 6000
        • Theravance Biopharma Investigational Site
      • Stara Zagora, Bulgaria, 6001
        • Theravance Biopharma Investigational Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Theravance Biopharma Investigational Site
    • Sofiya
      • Sofia, Sofiya, Bulgaria, 1303
        • Theravance Biopharma Investigational Site
      • Sofia, Sofiya, Bulgaria, 1527
        • Theravance Biopharma Investigational Site
      • Sofia, Sofiya, Bulgaria, 1784
        • Theravance Biopharma Investigational Site
  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Theravance Biopharma Investigational Site
  • France
    • Champagne-ardenne
      • Reims, Champagne-ardenne, France, 51092
        • Theravance Biopharma Investigational Site
    • Languedoc-roussillon
      • Montpellier Cedex 5, Languedoc-roussillon, France, 34295
        • Theravance Biopharma Investigational Site
    • Limousin
      • Vandœuvre-lès-Nancy Cedex, Limousin, France, 54500
        • Theravance Biopharma Investigational Site
    • Midi-pyrenees
      • Toulouse Cedex 9, Midi-pyrenees, France, 31059
        • Theravance Biopharma Investigational Site
    • NORD Pas-de-calais
      • Lille Cedex, NORD Pas-de-calais, France, 59037
        • Theravance Biopharma Investigational Site
    • PAYS DE LA Loire
      • Nantes, PAYS DE LA Loire, France, 44000
        • Theravance Biopharma Investigational Site
    • Picardie
      • Amiens Cedex 1, Picardie, France, 80054
        • Theravance Biopharma Investigational Site
    • Rhone-alpes
      • Pierre-Bénite, Rhone-alpes, France, 69495
        • Theravance Biopharma Investigational Site
      • Saint-Étienne, Rhone-alpes, France, 42055
        • Theravance Biopharma Investigational Site
  • Georgia
      • Batumi, Georgia, 6010
        • Theravance Biopharma Investigational Site
      • Tbilisi, Georgia, 0114
        • Theravance Biopharma Investigational Site
      • Tbilisi, Georgia, 0159
        • Theravance Biopharma Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Theravance Biopharma Investigational Site
      • Berlin, Germany, 13353
        • Theravance Biopharma Investigational Site
    • Baden Wuerttemberg
      • Heidelberg, Baden Wuerttemberg, Germany
        • Theravance Biopharma Investigational Site
    • Schleswig-holstein
      • Kiel, Schleswig-holstein, Germany, 24105
        • Theravance Biopharma Investigational Site
  • Greece
    • Attica
      • Athens, Attica, Greece, 115 27
        • Theravance Biopharma Investigational Site
      • Athens, Attica, Greece, 11527
        • Theravance Biopharma Investigational Site #2
    • Crete
      • Heraklion, Crete, Greece, 71110
        • Theravance Biopharma Investigational Site
    • Peloponnese
      • Patra, Peloponnese, Greece, 265 04
        • Theravance Biopharma Investigational Site
  • Hungary
      • Budapest, Hungary, 1088
        • Theravance Biopharma Investigational Site
      • Budapest, Hungary, 1136
        • Theravance Biopharma Investigational Site
    • Fejer
      • Szekesfehervar, Fejer, Hungary, 8000
        • Theravance Biopharma Investigational Site
    • Hajdu-bihar
      • Debrecen, Hajdu-bihar, Hungary, 4032
        • Theravance Biopharma Investigational Site
    • Tolna
      • Szekszárd, Tolna, Hungary, 7100
        • Theravance Biopharma Investigational Site
  • Israel
      • Haifa, Israel, 31048
        • Theravance Biopharma Investigational Site
      • H̱olon, Israel, 5822012
        • Theravance Biopharma Investigational Site
      • Jerusalem, Israel, 9362410
        • Theravance Biopharma Investigational Site
      • Nahariya, Israel, 2210001
        • Theravance Biopharma Investigational Site
      • Pethah Tiqvā, Israel, 4941492
        • Theravance Biopharma Investigational Site
      • Reẖovot, Israel, 7661041
        • Theravance Biopharma Investigational Site
    • Rehoboth
      • Zerifin, Rehoboth, Israel, 7030000
        • Theravance Biopharma Investigational Site
  • Italy
      • Catanzaro, Italy, 88100
        • Theravance Biopharma Investigational Site
      • Pavia, Italy, 27100
        • Theravance Biopharma Investigational Site
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Theravance Biopharma Investigational Site
  • Japan
      • Chiba, Japan, 260-0852
        • Theravance Biopharma Investigational Site
      • Fukuoka, Japan, 814-0180
        • Theravance Biopharma Investigational Site
      • Kumamoto, Japan, 860-0004
        • Theravance Biopharma Investigational Site
      • Tokyo, Japan, 135-8577
        • Theravance Biopharma Investigational Site
      • Tokyo, Japan, 136-0075
        • Theravance Biopharma Investigational Site
      • Tokyo, Japan, 152-8902
        • Theravance Biopharma Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan, 457-8511
        • Theravance Biopharma Investigational Site
    • Chiba
      • Abiko, Chiba, Japan, 270-1168
        • Theravance Biopharma Investigational Site
      • Sakura, Chiba, Japan, 285-8741
        • Theravance Biopharma Investigational Site
    • Fukuoka
      • Kurume, Fukuoka, Japan, 839-0809
        • Theravance Biopharma Investigational Site
    • Gifu
      • Ōgaki, Gifu, Japan, 503-8502
        • Theravance Biopharma Investigational Site
    • Gunma
      • Isesaki, Gunma, Japan, 372-0817
        • Theravance Biopharma Investigational Site
    • Hiroshima
      • Hatsukaichi, Hiroshima, Japan, 738-8503
        • Theravance Biopharma Investigational Site
    • Hiroshima-ken
      • Hiroshima, Hiroshima-ken, Japan, 720-8520
        • Theravance Biopharma Investigational Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 211-8533
        • Theravance Biopharma Investigational Site
    • Miyagi
      • Sendai, Miyagi, Japan, 981-3213
        • Theravance Biopharma Investigational Site
    • Nagano
      • Suwa, Nagano, Japan, 392-8510
        • Theravance Biopharma Investigational Site
    • Oita
      • Ōita, Oita, Japan, 870-0033
        • Theravance Biopharma Investigational Site
    • Osaka
      • Fujiidera, Osaka, Japan, 583-0027
        • Theravance Biopharma Investigational Site
      • Izumiotsu, Osaka, Japan, 595-0027
        • Theravance Biopharma Investigational Site
    • Saitama
      • Tokorozawa, Saitama, Japan, 359-1114
        • Theravance Biopharma Investigational Site
    • Saitama Ken
      • Ageo Shi, Saitama Ken, Japan, 362-0075
        • Theravance Biopharma Investigational Site
    • Toyama
      • Kurobe, Toyama, Japan, 938-8502
        • Theravance Biopharma Investigational Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 42415
        • Theravance Biopharma Investigational Site
      • Seoul, Korea, Republic of, 03722
        • Theravance Biopharma Investigational Site
      • Seoul, Korea, Republic of, 06351
        • Theravance Biopharma Investigational Site
      • Seoul, Korea, Republic of, 5505
        • Theravance Biopharma Investigational Site
      • Seoul, Korea, Republic of, 130702
        • Theravance Biopharma Investigational Site
    • Gangwon-do
      • Wŏnju, Gangwon-do, Korea, Republic of, 26426
        • Theravance Biopharma Investigational Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16247
        • Theravance Biopharma Investigational Site
  • Poland
      • Świętokrzyskie, Poland, 28-200
        • Theravance Biopharma Investigational Site
    • Dolnoslaskie
      • Wrocław, Dolnoslaskie, Poland, 53-333
        • Theravance Biopharma Investigational Site
      • Wrocław, Dolnoslaskie, Poland, 54-416
        • Theravance Biopharma Investigational Site
    • Kujawsko-Pomorskie
      • Toruń, Kujawsko-Pomorskie, Poland, 71-685
        • Theravance Biopharma Investigational Site
      • Włocławek, Kujawsko-Pomorskie, Poland, 87-800
        • Theravance Biopharma Investigational Site
    • Lodzkie
      • Ksawerów, Lodzkie, Poland, 95-054
        • Theravance Biopharma Investigational Site
      • Łódź, Lodzkie, Poland, 91-034
        • Theravance Biopharma Investigational Site
      • Łódź, Lodzkie, Poland, 90-302
        • Theravance Biopharma Investigational Site
    • Malopolskie
      • Kraków, Malopolskie, Poland, 31-501
        • Theravance Biopharma Investigational Site
    • Mazowieckie
      • Piaseczno, Mazowieckie, Poland, 05-500
        • Theravance Biopharma Investigational Site
      • Warszawa, Mazowieckie, Poland, 00-635
        • Theravance Biopharma Investigational Site
      • Warszawa, Mazowieckie, Poland, 00-728
        • Theravance Biopharma Investigational Site
      • Warszawa, Mazowieckie, Poland, 02-653
        • Theravance Biopharma Investigational Site
      • Warszawa, Mazowieckie, Poland, 03-580
        • Theravance Biopharma Investigational Site
    • Pomorskie
      • Sopot, Pomorskie, Poland, 81-756
        • Theravance Biopharma Investigational Site
    • Slaskie
      • Tychy, Slaskie, Poland, 43-100
        • Theravance Biopharma Investigational Site
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-369
        • Theravance Biopharma Investigational Site
      • Poznań, Wielkopolskie, Poland, 61-113
        • Theravance Biopharma Investigational Site
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71-434
        • Theravance Biopharma Investigational Site
      • Szczecin, Zachodniopomorskie, Poland, 71-685
        • Theravance Biopharma Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Theravance Biopharma Investigational Site
      • Guimarães, Portugal, 4835-044
        • Theravance Biopharma Investigational Site
      • Leiria, Portugal, 2410-197
        • Theravance Biopharma Investigational Site
      • Lisboa, Portugal, 1349-019
        • Theravance Biopharma Investigational Site
      • Santa Maria Da Feira, Portugal, 4520-211
        • Theravance Biopharma Investigational Site
      • Senhora Da Hora, Portugal, 4454-513
        • Theravance Biopharma Investigational Site
      • Viana Do Castelo, Portugal, 4901-858
        • Theravance Biopharma Investigational Site
      • Vila Nova de Gaia, Portugal, 4434502
        • Theravance Biopharma Investigational Site
  • Romania
      • Bucuresti, Romania, 02025
        • Theravance Biopharma Investigational Site
    • Timis
      • Timişoara, Timis, Romania, 300002
        • Theravance Biopharma Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Theravance Biopharma Investigational Site
      • Belgrade, Serbia, 11080
        • Theravance Biopharma Investigational Site
      • Kragujevac, Serbia, 34000
        • Theravance Biopharma Investigational Site
      • Nis, Serbia, 18000
        • Theravance Biopharma Investigational Site
      • Subotica, Serbia, 24000
        • Theravance Biopharma Investigational Site
      • Zrenjanin, Serbia, 23000
        • Theravance Biopharma Investigational Site
  • Slovakia
      • Nitra, Slovakia, 949 01
        • Theravance Biopharma Investigational Site
      • Šahy, Slovakia, 936 01
        • Theravance Biopharma Investigational Site
    • Prešovsky
      • Prešov, Prešovsky, Slovakia, 080 01
        • Theravance Biopharma Investigational Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Theravance Biopharma Investigational Site
  • Spain
      • Barcelona, Spain, 08022
        • Theravance Biopharma Investigational Site
      • Madrid, Spain, 28006
        • Theravance Biopharma Investigational Site
      • Sevilla, Spain, 41013
        • Theravance Biopharma Investigational Site
      • Valencia, Spain, 46010
        • Theravance Biopharma Investigational Site
  • Taiwan
      • Taichung, Taiwan, 40210
        • Theravance Biopharma Investigational Site
      • Tainan, Taiwan, 71004
        • Theravance Biopharma Investigational Site
      • Taipei, Taiwan, 116
        • Theravance Biopharma Investigational Site
    • Kaohsiung City
      • Kaohsiung, Kaohsiung City, Taiwan, 83301
        • Theravance Biopharma Investigational Site
  • Ukraine
      • Chernivtsi, Ukraine, 58001
        • Theravance Biopharma Investigational Site
      • Kharkiv, Ukraine, 61037
        • Theravance Biopharma Investigational Site
      • Lviv, Ukraine, 79010
        • Theravance Biopharma Investigational Site #2
      • Lviv, Ukraine, 79010
        • Theravance Biopharma Investigational Site
      • Ternopil, Ukraine, 46001
        • Theravance Biopharma Investigational Site
      • Vinnytsia, Ukraine, 21018
        • Theravance Biopharma Investigational Site
      • Zaporizhzhya, Ukraine, 69096
        • Theravance Biopharma Investigational Site
      • Zaporizhzhya, Ukraine, 69600
        • Theravance Biopharma Investigational Site
    • Kiev
      • Kyiv, Kiev, Ukraine, 01030
        • Theravance Biopharma Investigational Site
      • Kyiv, Kiev, Ukraine, 4107
        • Theravance Biopharma Investigational Site
    • Kiev City
      • Kiev, Kiev City, Ukraine, 04107
        • Theravance Biopharma Investigational Site
    • Poltava
      • Kremenchuk, Poltava, Ukraine, 39617
        • Theravance Biopharma Investigational Site
    • Transcarpathia
      • Úzhgorod, Transcarpathia, Ukraine, 88009
        • Theravance Biopharma Investigational Site
    • Transcarpathian
      • Úzhgorod, Transcarpathian, Ukraine, 88000
        • Theravance Biopharma Investigational Site
    • Vinnytsya
      • Vinnytsia, Vinnytsya, Ukraine, 21005
        • Theravance Biopharma Investigational Site
      • Vinnytsia, Vinnytsya, Ukraine, 21029
        • Theravance Biopharma Investigational Site
      • Vinnytsia, Vinnytsya, Ukraine, 20129
        • Theravance Biopharma Investigational Site #2
  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Theravance Biopharma Investigational Site
      • Lancaster, California, United States, 93534
        • Theravance Biopharma Investigational Site
      • Orange, California, United States, 92866
        • Theravance Biopharma Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Theravance Biopharma Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Theravance Biopharma Investigational Site
      • Clearwater, Florida, United States, 33756
        • Theravance Biopharma Investigational Site
      • Largo, Florida, United States, 33777
        • Theravance Biopharma Investigational Site
      • Miami, Florida, United States, 33155
        • Theravance Biopharma Investigational Site
      • Miami, Florida, United States, 33135
        • Theravance Biopharma Investigational Site
      • New Port Richey, Florida, United States, 34653
        • Theravance Biopharma Investigational Site
      • New Smyrna Beach, Florida, United States, 32168
        • Theravance Biopharma Investigational Site
      • Orlando, Florida, United States, 32803
        • Theravance Biopharma Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • Theravance Biopharma Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Theravance Biopharma Investigational Site
      • Suwanee, Georgia, United States, 30024
        • Theravance Biopharma Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Theravance Biopharma Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Theravance Biopharma Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Theravance Biopharma Investigational Site
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Theravance Biopharma Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Theravance Biopharma Investigational Site
    • Michigan
      • Troy, Michigan, United States, 48098
        • Theravance Biopharma Investigational Site
      • Wyoming, Michigan, United States, 48519
        • Theravance Biopharma Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Theravance Biopharma Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Theravance Biopharma Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Theravance Biopharma Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28215
        • Theravance Biopharma Investigational Site
      • Gastonia, North Carolina, United States, 28054
        • Theravance Biopharma Investigational Site
      • Greenville, North Carolina, United States, 27834-3761
        • Theravance Biopharma Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Theravance Biopharma Investigational Site
      • Smithfield, Pennsylvania, United States, 15478
        • Theravance Biopharma Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Theravance Biopharma Investigational Site
      • Rock Hill, South Carolina, United States, 29732
        • Theravance Biopharma Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 27212
        • Theravance Biopharma Investigational Site
    • Texas
      • Garland, Texas, United States, 75044
        • Theravance Biopharma Investigational Site
      • Houston, Texas, United States, 77002
        • Theravance Biopharma Investigational Site
      • San Antonio, Texas, United States, 78215
        • Theravance Biopharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Treatment TD-1473 with Dose A
Oral daily dose of TD-1473 for up to 156 weeks
Drug: TD-1473 Dose A
See Arm description
Experimental: Active Treatment TD-1473 with Dose B
Oral daily dose of TD-1473 for up to 156 weeks
Drug: TD-1473 Dose B
See Arm description
Experimental: Active Treatment TD-1473 with Dose C
Oral daily dose of TD-1473 for up to 156 weeks
Drug: TD-1473 Dose C
See Arm description

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theravance Biopharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0164
  • 2018-002135-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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