TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study
NCT ID: NCT03920254
Last Updated: 2022-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2/PHASE3
46 participants
INTERVENTIONAL
2020-07-23
2021-10-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy & Safety of TD-1473 in Ulcerative Colitis
NCT03758443
TD-1473 for Active Ulcerative Colitis (UC)
NCT02818686
Efficacy and Safety of TD-1473 in Crohn's Disease
NCT03635112
Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis
NCT03235752
An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
NCT03650413
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Treatment TD-1473 with Dose A
Oral daily dose of TD-1473 for up to 156 weeks
TD-1473 Dose A
See Arm description
Active Treatment TD-1473 with Dose B
Oral daily dose of TD-1473 for up to 156 weeks
TD-1473 Dose B
See Arm description
Active Treatment TD-1473 with Dose C
Oral daily dose of TD-1473 for up to 156 weeks
TD-1473 Dose C
See Arm description
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TD-1473 Dose A
See Arm description
TD-1473 Dose B
See Arm description
TD-1473 Dose C
See Arm description
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Theravance Biopharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Theravance Biopharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Theravance Biopharma Investigational Site
Chula Vista, California, United States
Theravance Biopharma Investigational Site
Lancaster, California, United States
Theravance Biopharma Investigational Site
Orange, California, United States
Theravance Biopharma Investigational Site
Colorado Springs, Colorado, United States
Theravance Biopharma Investigational Site
Aventura, Florida, United States
Theravance Biopharma Investigational Site
Clearwater, Florida, United States
Theravance Biopharma Investigational Site
Largo, Florida, United States
Theravance Biopharma Investigational Site
Miami, Florida, United States
Theravance Biopharma Investigational Site
Miami, Florida, United States
Theravance Biopharma Investigational Site
New Port Richey, Florida, United States
Theravance Biopharma Investigational Site
New Smyrna Beach, Florida, United States
Theravance Biopharma Investigational Site
Orlando, Florida, United States
Theravance Biopharma Investigational Site
Pembroke Pines, Florida, United States
Theravance Biopharma Investigational Site
Atlanta, Georgia, United States
Theravance Biopharma Investigational Site
Suwanee, Georgia, United States
Theravance Biopharma Investigational Site
Idaho Falls, Idaho, United States
Theravance Biopharma Investigational Site
Kansas City, Kansas, United States
Theravance Biopharma Investigational Site
Louisville, Kentucky, United States
Theravance Biopharma Investigational Site
Monroe, Louisiana, United States
Theravance Biopharma Investigational Site
Baltimore, Maryland, United States
Theravance Biopharma Investigational Site
Troy, Michigan, United States
Theravance Biopharma Investigational Site
Wyoming, Michigan, United States
Theravance Biopharma Investigational Site
Rochester, Minnesota, United States
Theravance Biopharma Investigational Site
Kansas City, Missouri, United States
Theravance Biopharma Investigational Site
Las Vegas, Nevada, United States
Theravance Biopharma Investigational Site
Charlotte, North Carolina, United States
Theravance Biopharma Investigational Site
Gastonia, North Carolina, United States
Theravance Biopharma Investigational Site
Greenville, North Carolina, United States
Theravance Biopharma Investigational Site
Pittsburgh, Pennsylvania, United States
Theravance Biopharma Investigational Site
Smithfield, Pennsylvania, United States
Theravance Biopharma Investigational Site
Greenville, South Carolina, United States
Theravance Biopharma Investigational Site
Rock Hill, South Carolina, United States
Theravance Biopharma Investigational Site
Nashville, Tennessee, United States
Theravance Biopharma Investigational Site
Garland, Texas, United States
Theravance Biopharma Investigational Site
Houston, Texas, United States
Theravance Biopharma Investigational Site
San Antonio, Texas, United States
Theravance Biopharma Investigational Site
South Brisbane, Queensland, Australia
Theravance Biopharma Investigational Site
Woolloongabba, Queensland, Australia
Theravance Biopharma Investigational Site
Malvern, Victoria, Australia
Theravance Biopharma Investigational Site
Murdoch, Western Australia, Australia
Theravance Biopharma Investigational Site
Sofia, Sofia, Bulgaria
Theravance Biopharma Investigational Site
Sofia, Sofia, Bulgaria
Theravance Biopharma Investigational Site
Sofia, Sofia, Bulgaria
Theravance Biopharma Investigational Site #2
Pleven, , Bulgaria
Theravance Biopharma Investigational Site
Pleven, , Bulgaria
Theravance Biopharma Investigational Site
Plovdiv, , Bulgaria
Theravance Biopharma Investigational Site
Plovdiv, , Bulgaria
Theravance Biopharma Investigational Site
Rousse, , Bulgaria
Theravance Biopharma Investigational Site
Sliven, , Bulgaria
Theravance Biopharma Investigational Site
Sofia, , Bulgaria
Theravance Biopharma Investigational Site
Stara Zagora, , Bulgaria
Theravance Biopharma Investigational Site
Stara Zagora, , Bulgaria
Theravance Biopharma Investigational Site
Veliko Tarnovo, , Bulgaria
Theravance Biopharma Investigational Site
Kingston, Ontario, Canada
Theravance Biopharma Investigational Site
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Theravance Biopharma Investigational Site
Saint-Etienne, Auvergne-Rhône-Alpes, France
Theravance Biopharma Investigational Site
Reims, Champagne-ardenne, France
Theravance Biopharma Investigational Site
Lille, Hauts-de-France, France
Theravance Biopharma Investigational Site
Montpellier, Languedoc-roussillon, France
Theravance Biopharma Investigational Site
Vandœuvre-lès-Nancy, Limousin, France
Theravance Biopharma Investigational Site
Toulouse, Midi-pyrenees, France
Theravance Biopharma Investigational Site
Nantes, Pays de la Loire Region, France
Theravance Biopharma Investigational Site
Amiens, Picardie, France
Theravance Biopharma Investigational Site
Batumi, , Georgia
Theravance Biopharma Investigational Site
Tbilisi, , Georgia
Theravance Biopharma Investigational Site
Tbilisi, , Georgia
Theravance Biopharma Investigational Site
Heidelberg, Baden-Wurttemberg, Germany
Theravance Biopharma Investigational Site
Kiel, Schleswig-Holstein, Germany
Theravance Biopharma Investigational Site
Berlin, , Germany
Theravance Biopharma Investigational Site
Berlin, , Germany
Theravance Biopharma Investigational Site
Athens, Attica, Greece
Theravance Biopharma Investigational Site #2
Athens, Attica, Greece
Theravance Biopharma Investigational Site
Heraklion, Crete, Greece
Theravance Biopharma Investigational Site
Patra, Peloponnese, Greece
Theravance Biopharma Investigational Site
Székesfehérvár, Fejér, Hungary
Theravance Biopharma Investigational Site
Debrecen, Hajdú-Bihar, Hungary
Theravance Biopharma Investigational Site
Szekszárd, Tolna County, Hungary
Theravance Biopharma Investigational Site
Budapest, , Hungary
Theravance Biopharma Investigational Site
Budapest, , Hungary
Theravance Biopharma Investigational Site
Ẕerifin, Rehoboth, Israel
Theravance Biopharma Investigational Site
Haifa, , Israel
Theravance Biopharma Investigational Site
Holon, , Israel
Theravance Biopharma Investigational Site
Jerusalem, , Israel
Theravance Biopharma Investigational Site
Nahariya, , Israel
Theravance Biopharma Investigational Site
Petah Tikva, , Israel
Theravance Biopharma Investigational Site
Rehovot, , Israel
Theravance Biopharma Investigational Site
Rozzano, Milano, Italy
Theravance Biopharma Investigational Site
Catanzaro, , Italy
Theravance Biopharma Investigational Site
Pavia, , Italy
Theravance Biopharma Investigational Site
Nagoya, Aichi-ken, Japan
Theravance Biopharma Investigational Site
Abiko, Chiba, Japan
Theravance Biopharma Investigational Site
Sakura, Chiba, Japan
Theravance Biopharma Investigational Site
Kurume, Fukuoka, Japan
Theravance Biopharma Investigational Site
Ōgaki, Gifu, Japan
Theravance Biopharma Investigational Site
Isesaki, Gunma, Japan
Theravance Biopharma Investigational Site
Hatsukaichi, Hiroshima, Japan
Theravance Biopharma Investigational Site
Hiroshima, Hiroshima, Japan
Theravance Biopharma Investigational Site
Kawasaki, Kanagawa, Japan
Theravance Biopharma Investigational Site
Sendai, Miyagi, Japan
Theravance Biopharma Investigational Site
Suwa, Nagano, Japan
Theravance Biopharma Investigational Site
Ōita, Oita Prefecture, Japan
Theravance Biopharma Investigational Site
Fujiidera, Osaka, Japan
Theravance Biopharma Investigational Site
Izumiōtsu, Osaka, Japan
Theravance Biopharma Investigational Site
Ageo Shi, Saitama, Japan
Theravance Biopharma Investigational Site
Tokorozawa, Saitama, Japan
Theravance Biopharma Investigational Site
Kurobe-shi, Toyama, Japan
Theravance Biopharma Investigational Site
Chiba, , Japan
Theravance Biopharma Investigational Site
Fukuoka, , Japan
Theravance Biopharma Investigational Site
Kumamoto, , Japan
Theravance Biopharma Investigational Site
Tokyo, , Japan
Theravance Biopharma Investigational Site
Tokyo, , Japan
Theravance Biopharma Investigational Site
Tokyo, , Japan
Theravance Biopharma Investigational Site
Poznan, Greater Poland Voivodeship, Poland
Theravance Biopharma Investigational Site
Poznan, Greater Poland Voivodeship, Poland
Theravance Biopharma Investigational Site
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Theravance Biopharma Investigational Site
Włocławek, Kuyavian-Pomeranian Voivodeship, Poland
Theravance Biopharma Investigational Site
Krakow, Lesser Poland Voivodeship, Poland
Theravance Biopharma Investigational Site
Wroclaw, Lower Silesian Voivodeship, Poland
Theravance Biopharma Investigational Site
Wroclaw, Lower Silesian Voivodeship, Poland
Theravance Biopharma Investigational Site
Piaseczno, Masovian Voivodeship, Poland
Theravance Biopharma Investigational Site
Warsaw, Masovian Voivodeship, Poland
Theravance Biopharma Investigational Site
Warsaw, Masovian Voivodeship, Poland
Theravance Biopharma Investigational Site
Warsaw, Masovian Voivodeship, Poland
Theravance Biopharma Investigational Site
Warsaw, Masovian Voivodeship, Poland
Theravance Biopharma Investigational Site
Sopot, Pomeranian Voivodeship, Poland
Theravance Biopharma Investigational Site
Tychy, Silesian Voivodeship, Poland
Theravance Biopharma Investigational Site
Szczecin, West Pomeranian Voivodeship, Poland
Theravance Biopharma Investigational Site
Szczecin, West Pomeranian Voivodeship, Poland
Theravance Biopharma Investigational Site
Świętokrzyskie, , Poland
Theravance Biopharma Investigational Site
Ksawerów, Łódź Voivodeship, Poland
Theravance Biopharma Investigational Site
Lodz, Łódź Voivodeship, Poland
Theravance Biopharma Investigational Site
Lodz, Łódź Voivodeship, Poland
Theravance Biopharma Investigational Site
Coimbra, , Portugal
Theravance Biopharma Investigational Site
Guimarães, , Portugal
Theravance Biopharma Investigational Site
Leiria, , Portugal
Theravance Biopharma Investigational Site
Lisbon, , Portugal
Theravance Biopharma Investigational Site
Santa Maria da Feira, , Portugal
Theravance Biopharma Investigational Site
Senhora da Hora, , Portugal
Theravance Biopharma Investigational Site
Viana do Castelo, , Portugal
Theravance Biopharma Investigational Site
Vila Nova de Gaia, , Portugal
Theravance Biopharma Investigational Site
Timișoara, Timiș County, Romania
Theravance Biopharma Investigational Site
Bucharest, , Romania
Theravance Biopharma Investigational Site
Belgrade, , Serbia
Theravance Biopharma Investigational Site
Belgrade, , Serbia
Theravance Biopharma Investigational Site
Kragujevac, , Serbia
Theravance Biopharma Investigational Site
Niš, , Serbia
Theravance Biopharma Investigational Site
Subotica, , Serbia
Theravance Biopharma Investigational Site
Zrenjanin, , Serbia
Theravance Biopharma Investigational Site
Prešov, Prešovsky, Slovakia
Theravance Biopharma Investigational Site
Nitra, , Slovakia
Theravance Biopharma Investigational Site
Šahy, , Slovakia
Theravance Biopharma Investigational Site
Johannesburg, Gauteng, South Africa
Theravance Biopharma Investigational Site
Wŏnju, Gangwon-do, South Korea
Theravance Biopharma Investigational Site
Suwon, Gyeonggi-do, South Korea
Theravance Biopharma Investigational Site
Daegu, , South Korea
Theravance Biopharma Investigational Site
Seoul, , South Korea
Theravance Biopharma Investigational Site
Seoul, , South Korea
Theravance Biopharma Investigational Site
Seoul, , South Korea
Theravance Biopharma Investigational Site
Seoul, , South Korea
Theravance Biopharma Investigational Site
Barcelona, , Spain
Theravance Biopharma Investigational Site
Madrid, , Spain
Theravance Biopharma Investigational Site
Seville, , Spain
Theravance Biopharma Investigational Site
Valencia, , Spain
Theravance Biopharma Investigational Site
Kaohsiung City, Kaohsiung City, Taiwan
Theravance Biopharma Investigational Site
Taichung, , Taiwan
Theravance Biopharma Investigational Site
Tainan City, , Taiwan
Theravance Biopharma Investigational Site
Taipei, , Taiwan
Theravance Biopharma Investigational Site
Kiev, KIEV CITY, Ukraine
Theravance Biopharma Investigational Site
Kyiv, Kyiv City, Ukraine
Theravance Biopharma Investigational Site
Kyiv, Kyiv City, Ukraine
Theravance Biopharma Investigational Site
Kremenchuk, Poltava Oblast, Ukraine
Theravance Biopharma Investigational Site
Uzhhorod, Transcarpathian, Ukraine
Theravance Biopharma Investigational Site #2
Vinnytsia, Vinnytsya, Ukraine
Theravance Biopharma Investigational Site
Vinnytsia, Vinnytsya, Ukraine
Theravance Biopharma Investigational Site
Vinnytsia, Vinnytsya, Ukraine
Theravance Biopharma Investigational Site
Uzhhorod, Zakarpattia Oblast, Ukraine
Theravance Biopharma Investigational Site
Chernivtsi, , Ukraine
Theravance Biopharma Investigational Site
Kharkiv, , Ukraine
Theravance Biopharma Investigational Site #2
Lviv, , Ukraine
Theravance Biopharma Investigational Site
Lviv, , Ukraine
Theravance Biopharma Investigational Site
Ternopil, , Ukraine
Theravance Biopharma Investigational Site
Vinnytsia, , Ukraine
Theravance Biopharma Investigational Site
Zaporizhzhya, , Ukraine
Theravance Biopharma Investigational Site
Zaporizhzhya, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-002135-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0164
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.