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

Ulcerative Colitis (UC) Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03920254
• Other study ID #: 0164
• Secondary ID: 2018-002135-19
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 23, 2020
• Est. completion date: October 27, 2021

Study information

• Verified date: October 2022
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis (UC)

Intervention

Drug:
• TD-1473 Dose A
See Arm description
• TD-1473 Dose B
See Arm description
• TD-1473 Dose C
See Arm description

Locations

Country	Name	City	State
Australia	Theravance Biopharma Investigational Site	Malvern	Victoria
Australia	Theravance Biopharma Investigational Site	Murdoch	Western Australia
Australia	Theravance Biopharma Investigational Site	South Brisbane	Queensland
Australia	Theravance Biopharma Investigational Site	Woolloongabba	Queensland
Bulgaria	Theravance Biopharma Investigational Site	Pleven
Bulgaria	Theravance Biopharma Investigational Site #2	Pleven
Bulgaria	Theravance Biopharma Investigational Site	Plovdiv
Bulgaria	Theravance Biopharma Investigational Site	Plovdiv
Bulgaria	Theravance Biopharma Investigational Site	Ruse
Bulgaria	Theravance Biopharma Investigational Site	Sliven
Bulgaria	Theravance Biopharma Investigational Site	Sofia
Bulgaria	Theravance Biopharma Investigational Site	Sofia	Sofiya
Bulgaria	Theravance Biopharma Investigational Site	Sofia	Sofiya
Bulgaria	Theravance Biopharma Investigational Site	Sofia	Sofiya
Bulgaria	Theravance Biopharma Investigational Site	Stara Zagora
Bulgaria	Theravance Biopharma Investigational Site	Stara Zagora
Bulgaria	Theravance Biopharma Investigational Site	Veliko Tarnovo
Canada	Theravance Biopharma Investigational Site	Kingston	Ontario
France	Theravance Biopharma Investigational Site	Amiens Cedex 1	Picardie
France	Theravance Biopharma Investigational Site	Lille Cedex	NORD Pas-de-calais
France	Theravance Biopharma Investigational Site	Montpellier Cedex 5	Languedoc-roussillon
France	Theravance Biopharma Investigational Site	Nantes	PAYS DE LA Loire
France	Theravance Biopharma Investigational Site	Pierre-Bénite	Rhone-alpes
France	Theravance Biopharma Investigational Site	Reims	Champagne-ardenne
France	Theravance Biopharma Investigational Site	Saint-Étienne	Rhone-alpes
France	Theravance Biopharma Investigational Site	Toulouse Cedex 9	Midi-pyrenees
France	Theravance Biopharma Investigational Site	Vandœuvre-lès-Nancy Cedex	Limousin
Georgia	Theravance Biopharma Investigational Site	Batumi
Georgia	Theravance Biopharma Investigational Site	Tbilisi
Georgia	Theravance Biopharma Investigational Site	Tbilisi
Germany	Theravance Biopharma Investigational Site	Berlin
Germany	Theravance Biopharma Investigational Site	Berlin
Germany	Theravance Biopharma Investigational Site	Heidelberg	Baden Wuerttemberg
Germany	Theravance Biopharma Investigational Site	Kiel	Schleswig-holstein
Greece	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
Hungary	Theravance Biopharma Investigational Site	Budapest
Hungary	Theravance Biopharma Investigational Site	Budapest
Hungary	Theravance Biopharma Investigational Site	Debrecen	Hajdu-bihar
Hungary	Theravance Biopharma Investigational Site	Szekesfehervar	Fejer
Hungary	Theravance Biopharma Investigational Site	Szekszárd	Tolna
Israel	Theravance Biopharma Investigational Site	H_olon
Israel	Theravance Biopharma Investigational Site	Haifa
Israel	Theravance Biopharma Investigational Site	Jerusalem
Israel	Theravance Biopharma Investigational Site	Nahariya
Israel	Theravance Biopharma Investigational Site	Pethah Tiqva
Israel	Theravance Biopharma Investigational Site	Re?ovot
Israel	Theravance Biopharma Investigational Site	Zerifin	Rehoboth
Italy	Theravance Biopharma Investigational Site	Catanzaro
Italy	Theravance Biopharma Investigational Site	Pavia
Italy	Theravance Biopharma Investigational Site	Rozzano	Milano
Japan	Theravance Biopharma Investigational Site	Abiko	Chiba
Japan	Theravance Biopharma Investigational Site	Ageo Shi	Saitama Ken
Japan	Theravance Biopharma Investigational Site	Chiba
Japan	Theravance Biopharma Investigational Site	Fujiidera	Osaka
Japan	Theravance Biopharma Investigational Site	Fukuoka
Japan	Theravance Biopharma Investigational Site	Hatsukaichi	Hiroshima
Japan	Theravance Biopharma Investigational Site	Hiroshima	Hiroshima-ken
Japan	Theravance Biopharma Investigational Site	Isesaki	Gunma
Japan	Theravance Biopharma Investigational Site	Izumiotsu	Osaka
Japan	Theravance Biopharma Investigational Site	Kawasaki	Kanagawa
Japan	Theravance Biopharma Investigational Site	Kumamoto
Japan	Theravance Biopharma Investigational Site	Kurobe	Toyama
Japan	Theravance Biopharma Investigational Site	Kurume	Fukuoka
Japan	Theravance Biopharma Investigational Site	Nagoya	Aichi
Japan	Theravance Biopharma Investigational Site	Ogaki	Gifu
Japan	Theravance Biopharma Investigational Site	Oita	Oita
Japan	Theravance Biopharma Investigational Site	Sakura	Chiba
Japan	Theravance Biopharma Investigational Site	Sendai	Miyagi
Japan	Theravance Biopharma Investigational Site	Suwa	Nagano
Japan	Theravance Biopharma Investigational Site	Tokorozawa	Saitama
Japan	Theravance Biopharma Investigational Site	Tokyo
Japan	Theravance Biopharma Investigational Site	Tokyo
Japan	Theravance Biopharma Investigational Site	Tokyo
Korea, Republic of	Theravance Biopharma Investigational Site	Daegu
Korea, Republic of	Theravance Biopharma Investigational Site	Seoul
Korea, Republic of	Theravance Biopharma Investigational Site	Seoul
Korea, Republic of	Theravance Biopharma Investigational Site	Seoul
Korea, Republic of	Theravance Biopharma Investigational Site	Seoul
Korea, Republic of	Theravance Biopharma Investigational Site	Suwon	Gyeonggi-do
Korea, Republic of	Theravance Biopharma Investigational Site	Wonju	Gangwon-do
Poland	Theravance Biopharma Investigational Site	Kraków	Malopolskie
Poland	Theravance Biopharma Investigational Site	Ksawerów	Lodzkie
Poland	Theravance Biopharma Investigational Site	Lódz	Lodzkie
Poland	Theravance Biopharma Investigational Site	Lódz	Lodzkie
Poland	Theravance Biopharma Investigational Site	Piaseczno	Mazowieckie
Poland	Theravance Biopharma Investigational Site	Poznan	Wielkopolskie
Poland	Theravance Biopharma Investigational Site	Poznan	Wielkopolskie
Poland	Theravance Biopharma Investigational Site	Sopot	Pomorskie
Poland	Theravance Biopharma Investigational Site	Swietokrzyskie
Poland	Theravance Biopharma Investigational Site	Szczecin	Zachodniopomorskie
Poland	Theravance Biopharma Investigational Site	Szczecin	Zachodniopomorskie
Poland	Theravance Biopharma Investigational Site	Torun	Kujawsko-Pomorskie
Poland	Theravance Biopharma Investigational Site	Tychy	Slaskie
Poland	Theravance Biopharma Investigational Site	Warszawa	Mazowieckie
Poland	Theravance Biopharma Investigational Site	Warszawa	Mazowieckie
Poland	Theravance Biopharma Investigational Site	Warszawa	Mazowieckie
Poland	Theravance Biopharma Investigational Site	Warszawa	Mazowieckie
Poland	Theravance Biopharma Investigational Site	Wloclawek	Kujawsko-Pomorskie
Poland	Theravance Biopharma Investigational Site	Wroclaw	Dolnoslaskie
Poland	Theravance Biopharma Investigational Site	Wroclaw	Dolnoslaskie
Portugal	Theravance Biopharma Investigational Site	Coimbra
Portugal	Theravance Biopharma Investigational Site	Guimarães
Portugal	Theravance Biopharma Investigational Site	Leiria
Portugal	Theravance Biopharma Investigational Site	Lisboa
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
Romania	Theravance Biopharma Investigational Site	Bucuresti
Romania	Theravance Biopharma Investigational Site	Timisoara	Timis
Serbia	Theravance Biopharma Investigational Site	Belgrade
Serbia	Theravance Biopharma Investigational Site	Belgrade
Serbia	Theravance Biopharma Investigational Site	Kragujevac
Serbia	Theravance Biopharma Investigational Site	Nis
Serbia	Theravance Biopharma Investigational Site	Subotica
Serbia	Theravance Biopharma Investigational Site	Zrenjanin
Slovakia	Theravance Biopharma Investigational Site	Šahy
Slovakia	Theravance Biopharma Investigational Site	Nitra
Slovakia	Theravance Biopharma Investigational Site	Prešov	Prešovsky
South Africa	Theravance Biopharma Investigational Site	Johannesburg	Gauteng
Spain	Theravance Biopharma Investigational Site	Barcelona
Spain	Theravance Biopharma Investigational Site	Madrid
Spain	Theravance Biopharma Investigational Site	Sevilla
Spain	Theravance Biopharma Investigational Site	Valencia
Taiwan	Theravance Biopharma Investigational Site	Kaohsiung	Kaohsiung City
Taiwan	Theravance Biopharma Investigational Site	Taichung
Taiwan	Theravance Biopharma Investigational Site	Tainan
Taiwan	Theravance Biopharma Investigational Site	Taipei
Ukraine	Theravance Biopharma Investigational Site	Chernivtsi
Ukraine	Theravance Biopharma Investigational Site	Kharkiv
Ukraine	Theravance Biopharma Investigational Site	Kiev	Kiev City
Ukraine	Theravance Biopharma Investigational Site	Kremenchuk	Poltava
Ukraine	Theravance Biopharma Investigational Site	Kyiv	Kiev
Ukraine	Theravance Biopharma Investigational Site	Kyiv	Kiev
Ukraine	Theravance Biopharma Investigational Site	Lviv
Ukraine	Theravance Biopharma Investigational Site #2	Lviv
Ukraine	Theravance Biopharma Investigational Site	Ternopil
Ukraine	Theravance Biopharma Investigational Site	Úzhgorod	Transcarpathian
Ukraine	Theravance Biopharma Investigational Site	Úzhgorod	Transcarpathia
Ukraine	Theravance Biopharma Investigational Site	Vinnytsia	Vinnytsya
Ukraine	Theravance Biopharma Investigational Site	Vinnytsia	Vinnytsya
Ukraine	Theravance Biopharma Investigational Site	Vinnytsia
Ukraine	Theravance Biopharma Investigational Site #2	Vinnytsia	Vinnytsya
Ukraine	Theravance Biopharma Investigational Site	Zaporizhzhya
Ukraine	Theravance Biopharma Investigational Site	Zaporizhzhya
United States	Theravance Biopharma Investigational Site	Atlanta	Georgia
United States	Theravance Biopharma Investigational Site	Aventura	Florida
United States	Theravance Biopharma Investigational Site	Baltimore	Maryland
United States	Theravance Biopharma Investigational Site	Charlotte	North Carolina
United States	Theravance Biopharma Investigational Site	Chula Vista	California
United States	Theravance Biopharma Investigational Site	Clearwater	Florida
United States	Theravance Biopharma Investigational Site	Colorado Springs	Colorado
United States	Theravance Biopharma Investigational Site	Garland	Texas
United States	Theravance Biopharma Investigational Site	Gastonia	North Carolina
United States	Theravance Biopharma Investigational Site	Greenville	North Carolina
United States	Theravance Biopharma Investigational Site	Greenville	South Carolina
United States	Theravance Biopharma Investigational Site	Houston	Texas
United States	Theravance Biopharma Investigational Site	Idaho Falls	Idaho
United States	Theravance Biopharma Investigational Site	Kansas City	Kansas
United States	Theravance Biopharma Investigational Site	Kansas City	Missouri
United States	Theravance Biopharma Investigational Site	Lancaster	California
United States	Theravance Biopharma Investigational Site	Largo	Florida
United States	Theravance Biopharma Investigational Site	Las Vegas	Nevada
United States	Theravance Biopharma Investigational Site	Louisville	Kentucky
United States	Theravance Biopharma Investigational Site	Miami	Florida
United States	Theravance Biopharma Investigational Site	Miami	Florida
United States	Theravance Biopharma Investigational Site	Monroe	Louisiana
United States	Theravance Biopharma Investigational Site	Nashville	Tennessee
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	Orange	California
United States	Theravance Biopharma Investigational Site	Orlando	Florida
United States	Theravance Biopharma Investigational Site	Pembroke Pines	Florida
United States	Theravance Biopharma Investigational Site	Pittsburgh	Pennsylvania
United States	Theravance Biopharma Investigational Site	Rochester	Minnesota
United States	Theravance Biopharma Investigational Site	Rock Hill	South Carolina
United States	Theravance Biopharma Investigational Site	San Antonio	Texas
United States	Theravance Biopharma Investigational Site	Smithfield	Pennsylvania
United States	Theravance Biopharma Investigational Site	Suwanee	Georgia
United States	Theravance Biopharma Investigational Site	Troy	Michigan
United States	Theravance Biopharma Investigational Site	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  France,  Georgia,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Portugal,  Romania,  Serbia,  Slovakia,  South Africa,  Spain,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)