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

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: Terminated
• Conditions: Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: TD-1473 Dose A; Drug: TD-1473 Dose B; Drug: TD-1473 Dose C

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: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2; Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Theravance Biopharma
• Investigators: Study Director: Medical Director, Theravance Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): October 27, 2021
• Study Completion (Actual): October 27, 2021

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; IBD; Ulcerative colitis; JAK inhibitor; UC; Janus kinase inhibitor; TD-1473; Intestinal restriction; Gut-selective
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID 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