Clinical trial NCT03920254: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis (UC)
Keywords: TD-1473
Janus kinase inhibitor
JAK inhibitor
Inflammatory Bowel Disease
IBD
Ulcerative colitis
UC
Intestinal restriction
Gut-selective
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2019-04-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Long Term Safety (LTS)
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Theravance Biopharma Investigational Site
state: California
city: Lancaster
country: United States
facility: Theravance Biopharma Investigational Site
state: California
city: Orange
country: United States
facility: Theravance Biopharma Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Theravance Biopharma Investigational Site
state: Colorado
city: Aventura
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Largo
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Miami
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Miami
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: New Smyrna Beach
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Orlando
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Theravance Biopharma Investigational Site
state: Georgia
city: Suwanee
country: United States
facility: Theravance Biopharma Investigational Site
state: Georgia
city: Idaho Falls
country: United States
facility: Theravance Biopharma Investigational Site
state: Idaho
city: Kansas City
country: United States
facility: Theravance Biopharma Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Theravance Biopharma Investigational Site
state: Kentucky
city: Monroe
country: United States
facility: Theravance Biopharma Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Theravance Biopharma Investigational Site
state: Maryland
city: Troy
country: United States
facility: Theravance Biopharma Investigational Site
state: Michigan
city: Wyoming
country: United States
facility: Theravance Biopharma Investigational Site
state: Michigan
city: Rochester
country: United States
facility: Theravance Biopharma Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: Theravance Biopharma Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Theravance Biopharma Investigational Site
state: Nevada
city: Charlotte
country: United States
facility: Theravance Biopharma Investigational Site
state: North Carolina
city: Gastonia
country: United States
facility: Theravance Biopharma Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Theravance Biopharma Investigational Site
state: North Carolina
city: Pittsburgh
country: United States
facility: Theravance Biopharma Investigational Site
state: Pennsylvania
city: Smithfield
country: United States
facility: Theravance Biopharma Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Theravance Biopharma Investigational Site
state: South Carolina
city: Rock Hill
country: United States
facility: Theravance Biopharma Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Theravance Biopharma Investigational Site
state: Tennessee
city: Garland
country: United States
facility: Theravance Biopharma Investigational Site
state: Texas
city: Houston
country: United States
facility: Theravance Biopharma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Theravance Biopharma Investigational Site
state: Texas
city: South Brisbane
country: Australia
facility: Theravance Biopharma Investigational Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Theravance Biopharma Investigational Site
state: Queensland
city: Malvern
country: Australia
facility: Theravance Biopharma Investigational Site
state: Victoria
city: Murdoch
country: Australia
facility: Theravance Biopharma Investigational Site
state: Western Australia
city: Sofia
country: Bulgaria
facility: Theravance Biopharma Investigational Site
state: Sofiya
city: Sofia
country: Bulgaria
facility: Theravance Biopharma Investigational Site
state: Sofiya
city: Sofia
country: Bulgaria
facility: Theravance Biopharma Investigational Site
state: Sofiya
city: Pleven
country: Bulgaria
facility: Theravance Biopharma Investigational Site #2
city: Pleven
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Plovdiv
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Plovdiv
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Ruse
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Sliven
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Sofia
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Kingston
country: Canada
facility: Theravance Biopharma Investigational Site
state: Ontario
city: Reims
country: France
facility: Theravance Biopharma Investigational Site
state: Champagne-ardenne
city: Montpellier Cedex 5
country: France
facility: Theravance Biopharma Investigational Site
state: Languedoc-roussillon
city: Vandœuvre-lès-Nancy Cedex
country: France
facility: Theravance Biopharma Investigational Site
state: Limousin
city: Toulouse Cedex 9
country: France
facility: Theravance Biopharma Investigational Site
state: Midi-pyrenees
city: Lille Cedex
country: France
facility: Theravance Biopharma Investigational Site
state: NORD Pas-de-calais
city: Nantes
country: France
facility: Theravance Biopharma Investigational Site
state: PAYS DE LA Loire
city: Amiens Cedex 1
country: France
facility: Theravance Biopharma Investigational Site
state: Picardie
city: Pierre-Bénite
country: France
facility: Theravance Biopharma Investigational Site
state: Rhone-alpes
city: Saint-Étienne
country: France
facility: Theravance Biopharma Investigational Site
state: Rhone-alpes
city: Batumi
country: Georgia
facility: Theravance Biopharma Investigational Site
city: Tbilisi
country: Georgia
facility: Theravance Biopharma Investigational Site
city: Tbilisi
country: Georgia
facility: Theravance Biopharma Investigational Site
city: Heidelberg
country: Germany
facility: Theravance Biopharma Investigational Site
state: Baden Wuerttemberg
city: Kiel
country: Germany
facility: Theravance Biopharma Investigational Site
state: Schleswig-holstein
city: Berlin
country: Germany
facility: Theravance Biopharma Investigational Site
city: Berlin
country: Germany
facility: Theravance Biopharma Investigational Site
city: Athens
country: Greece
facility: Theravance Biopharma Investigational Site
state: Attica
city: Athens
country: Greece
facility: Theravance Biopharma Investigational Site #2
state: Attica
city: Heraklion
country: Greece
facility: Theravance Biopharma Investigational Site
state: Crete
city: Patra
country: Greece
facility: Theravance Biopharma Investigational Site
state: Peloponnese
city: Szekesfehervar
country: Hungary
facility: Theravance Biopharma Investigational Site
state: Fejer
city: Debrecen
country: Hungary
facility: Theravance Biopharma Investigational Site
state: Hajdu-bihar
city: Szekszárd
country: Hungary
facility: Theravance Biopharma Investigational Site
state: Tolna
city: Budapest
country: Hungary
facility: Theravance Biopharma Investigational Site
city: Budapest
country: Hungary
facility: Theravance Biopharma Investigational Site
city: Zerifin
country: Israel
facility: Theravance Biopharma Investigational Site
state: Rehoboth
city: Haifa
country: Israel
facility: Theravance Biopharma Investigational Site
city: H̱olon
country: Israel
facility: Theravance Biopharma Investigational Site
city: Jerusalem
country: Israel
facility: Theravance Biopharma Investigational Site
city: Nahariya
country: Israel
facility: Theravance Biopharma Investigational Site
city: Pethah Tiqvā
country: Israel
facility: Theravance Biopharma Investigational Site
city: Reẖovot
country: Israel
facility: Theravance Biopharma Investigational Site
city: Rozzano
country: Italy
facility: Theravance Biopharma Investigational Site
state: Milano
city: Catanzaro
country: Italy
facility: Theravance Biopharma Investigational Site
city: Pavia
country: Italy
facility: Theravance Biopharma Investigational Site
city: Nagoya
country: Japan
facility: Theravance Biopharma Investigational Site
state: Aichi
city: Abiko
country: Japan
facility: Theravance Biopharma Investigational Site
state: Chiba
city: Sakura
country: Japan
facility: Theravance Biopharma Investigational Site
state: Chiba
city: Kurume
country: Japan
facility: Theravance Biopharma Investigational Site
state: Fukuoka
city: Ōgaki
country: Japan
facility: Theravance Biopharma Investigational Site
state: Gifu
city: Isesaki
country: Japan
facility: Theravance Biopharma Investigational Site
state: Gunma
city: Hiroshima
country: Japan
facility: Theravance Biopharma Investigational Site
state: Hiroshima-ken
city: Hatsukaichi
country: Japan
facility: Theravance Biopharma Investigational Site
state: Hiroshima
city: Kawasaki
country: Japan
facility: Theravance Biopharma Investigational Site
state: Kanagawa
city: Sendai
country: Japan
facility: Theravance Biopharma Investigational Site
state: Miyagi
city: Suwa
country: Japan
facility: Theravance Biopharma Investigational Site
state: Nagano
city: Ōita
country: Japan
facility: Theravance Biopharma Investigational Site
state: Oita
city: Fujiidera
country: Japan
facility: Theravance Biopharma Investigational Site
state: Osaka
city: Izumiotsu
country: Japan
facility: Theravance Biopharma Investigational Site
state: Osaka
city: Ageo Shi
country: Japan
facility: Theravance Biopharma Investigational Site
state: Saitama Ken
city: Tokorozawa
country: Japan
facility: Theravance Biopharma Investigational Site
state: Saitama
city: Kurobe
country: Japan
facility: Theravance Biopharma Investigational Site
state: Toyama
city: Chiba
country: Japan
facility: Theravance Biopharma Investigational Site
city: Fukuoka
country: Japan
facility: Theravance Biopharma Investigational Site
city: Kumamoto
country: Japan
facility: Theravance Biopharma Investigational Site
city: Tokyo
country: Japan
facility: Theravance Biopharma Investigational Site
city: Tokyo
country: Japan
facility: Theravance Biopharma Investigational Site
city: Tokyo
country: Japan
facility: Theravance Biopharma Investigational Site
city: Wŏnju
country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
state: Gangwon-do
city: Suwon
country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
city: Wrocław
country: Poland
facility: Theravance Biopharma Investigational Site
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: Theravance Biopharma Investigational Site
state: Dolnoslaskie
city: Toruń
country: Poland
facility: Theravance Biopharma Investigational Site
state: Kujawsko-Pomorskie
city: Włocławek
country: Poland
facility: Theravance Biopharma Investigational Site
state: Kujawsko-Pomorskie
city: Ksawerów
country: Poland
facility: Theravance Biopharma Investigational Site
state: Lodzkie
city: Łódź
country: Poland
facility: Theravance Biopharma Investigational Site
state: Lodzkie
city: Łódź
country: Poland
facility: Theravance Biopharma Investigational Site
state: Lodzkie
city: Kraków
country: Poland
facility: Theravance Biopharma Investigational Site
state: Malopolskie
city: Piaseczno
country: Poland
facility: Theravance Biopharma Investigational Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Theravance Biopharma Investigational Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Theravance Biopharma Investigational Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Theravance Biopharma Investigational Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Theravance Biopharma Investigational Site
state: Mazowieckie
city: Sopot
country: Poland
facility: Theravance Biopharma Investigational Site
state: Pomorskie
city: Tychy
country: Poland
facility: Theravance Biopharma Investigational Site
state: Slaskie
city: Poznań
country: Poland
facility: Theravance Biopharma Investigational Site
state: Wielkopolskie
city: Poznań
country: Poland
facility: Theravance Biopharma Investigational Site
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Theravance Biopharma Investigational Site
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: Theravance Biopharma Investigational Site
state: Zachodniopomorskie
city: Świętokrzyskie
country: Poland
facility: Theravance Biopharma Investigational Site
city: Coimbra
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Guimarães
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Leiria
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Lisboa
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Santa Maria Da Feira
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Senhora Da Hora
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Viana Do Castelo
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Timişoara
country: Romania
facility: Theravance Biopharma Investigational Site
state: Timis
city: Bucuresti
country: Romania
facility: Theravance Biopharma Investigational Site
city: Belgrade
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Belgrade
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Kragujevac
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Nis
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Subotica
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Zrenjanin
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Prešov
country: Slovakia
facility: Theravance Biopharma Investigational Site
state: Prešovsky
city: Nitra
country: Slovakia
facility: Theravance Biopharma Investigational Site
city: Šahy
country: Slovakia
facility: Theravance Biopharma Investigational Site
city: Johannesburg
country: South Africa
facility: Theravance Biopharma Investigational Site
state: Gauteng
city: Barcelona
country: Spain
facility: Theravance Biopharma Investigational Site
city: Madrid
country: Spain
facility: Theravance Biopharma Investigational Site
city: Sevilla
country: Spain
facility: Theravance Biopharma Investigational Site
city: Valencia
country: Spain
facility: Theravance Biopharma Investigational Site
city: Kaohsiung
country: Taiwan
facility: Theravance Biopharma Investigational Site
state: Kaohsiung City
city: Taichung
country: Taiwan
facility: Theravance Biopharma Investigational Site
city: Tainan
country: Taiwan
facility: Theravance Biopharma Investigational Site
city: Taipei
country: Taiwan
facility: Theravance Biopharma Investigational Site
city: Kiev
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Kiev City
city: Kyiv
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Kiev
city: Kyiv
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Kiev
city: Kremenchuk
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Poltava
city: Úzhgorod
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Transcarpathian
city: Úzhgorod
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Transcarpathia
city: Vinnytsia
country: Ukraine
facility: Theravance Biopharma Investigational Site #2
state: Vinnytsya
city: Vinnytsia
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Vinnytsya
city: Vinnytsia
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Vinnytsya
city: Chernivtsi
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Kharkiv
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Lviv
country: Ukraine
facility: Theravance Biopharma Investigational Site #2
city: Lviv
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Ternopil
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Vinnytsia
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: Theravance Biopharma Investigational Site
Study officials:
affiliation: Theravance Biopharma
name: Medical Director
role: STUDY_DIRECTOR
References: