Efficacy and Safety of TD-1473 in Crohn's Disease (DIONE)

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo˗Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's Disease

A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: TD-1473; Drug: Placebo

Detailed Description

A Phase 2 multi-center, randomized, double blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 12 weeks of induction therapy with TD˗1473 in subjects with moderately-to-severely active Crohn's Disease. This study includes 3 phases: Screening, Induction, and Active Treatment Extension (ATE). The Induction phase of the study is a randomized, double blind, placebo controlled, parallel group study evaluating 2 oral dose levels of TD-1473 compared to placebo for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 in the ATE, for up to 48 additional weeks.

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Bankstown, New South Wales, Australia, 2200
      • Theravance Biopharma Investigational Site
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Theravance Biopharma Investigational Site
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Theravance Biopharma Investigational Site
• Austria
  • Carinthia
    • Klagenfurt am Wörthersee, Carinthia, Austria, 9020
      • Theravance Biopharma Investigational Site
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Theravance Biopharma Investigational Site
  • Vienna
    • Wien, Vienna, Austria, 1090
      • Theravance Biopharma Investigational Site
• Bulgaria
  • Dobrich, Bulgaria, 9300
    • Theravance Biopharma Investigational Site
  • Plovdiv, Bulgaria, 4004
    • Theravance Biopharma Investigational Site
  • Sliven, Bulgaria, 8800
    • 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
    • Sofia, Sofiya, Bulgaria, 1336
      • Theravance Biopharma Investigational Site
    • Sofia, Sofiya, Bulgaria, 1431
      • Theravance Biopharma Investigational Site
  • Turgovishte
    • Targovishte, Turgovishte, Bulgaria, 7700
      • Theravance Biopharma Investigational Site
• Croatia
  • Rijeka, Croatia, 51000
    • Theravance Biopharma Investigational Site
  • Split, Croatia, 21000
    • Theravance Biopharma Investigational Site
  • Zagreb, Croatia, 10000
    • Theravance Biopharma Investigational Site
  • Osijek-baranja
    • Osijek, Osijek-baranja, Croatia, 31 000
      • Theravance Biopharma Investigational Site
• France
  • Clichy, France, 92110
    • Theravance Biopharma Investigational Site
  • Vandœuvre-lès-Nancy, France, 54511
    • Theravance Biopharma Investigational Site
  • Auvergne
    • Saint Etienne, Auvergne, France, 42055
      • Theravance Biopharma Investigational Site
  • Champagne-ardenne
    • Reims, Champagne-ardenne, France, 51092
      • Theravance Biopharma Investigational Site
  • Ile-de-france
    • Colombes, Ile-de-france, France, 92701
      • Theravance Biopharma Investigational Site
  • Midi-pyrenees
    • Toulouse, Midi-pyrenees, France, 31059
      • Theravance Biopharma Investigational Site
  • Provence Alpes COTE D'azur
    • Nice, Provence Alpes COTE D'azur, France, 06202
      • Theravance Biopharma Investigational Site
  • Rhone-alpes
    • Pierre-Bénite, Rhone-alpes, France, 69495
      • Theravance Biopharma Investigational Site
• Georgia
  • Tbilisi, Georgia, 0114
    • Theravance Biopharma Investigational Site
  • Tbilisi, Georgia, 0159
    • Theravance Biopharma Investigational Site
• Germany
  • Berlin, Germany, 14050
    • Theravance Biopharma Investigational Site
  • Hamburg, Germany, 22559
    • Theravance Biopharma Investigational Site
  • Bayern
    • München, Bayern, Germany, 80331
      • Theravance Biopharma Investigational Site
    • München, Bayern, Germany, 81377
      • Theravance Biopharma Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • 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
  • Crete
    • Heraklion, Crete, Greece, 71110
      • Theravance Biopharma Investigational Site
• Hungary
  • Budapest, Hungary, H-1088
    • Theravance Biopharma Investigational Site
  • Bacs-kiskun
    • Baja, Bacs-kiskun, Hungary, 6500
      • Theravance Biopharma Investigational Site
  • Hajdu-bihar
    • Debrecen, Hajdu-bihar, Hungary, 4032
      • Theravance Biopharma Investigational Site
  • Heves
    • Gyöngyös, Heves, Hungary, 3200
      • Theravance Biopharma Investigational Site
• Israel
  • Haifa, Israel, 3339419
    • Theravance Biopharma Investigational Site
  • Holon, Israel, 5822012
    • Theravance Biopharma Investigational Site
  • Jerusalem, Israel, 9362410
    • Theravance Biopharma Investigational Site
  • Nahariya, Israel, 2210001
    • Theravance Biopharma Investigational Site
  • Petah Tikva, Israel, 4941492
    • Theravance Biopharma Investigational Site
  • Tel Aviv, Israel, 6423906
    • Theravance Biopharma Investigational Site
  • Rehoboth
    • Be'er Ya'aqov, Rehoboth, Israel, 7030000
      • Theravance Biopharma Investigational Site
    • Rehovot, Rehoboth, Israel, 7661041
      • Theravance Biopharma Investigational Site
  • Sharon
    • Kfar Saba, Sharon, Israel, 4428164
      • Theravance Biopharma Investigational Site
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Theravance Biopharma Investigational Site
  • Daegu, Korea, Republic of, 42601
    • Theravance Biopharma Investigational Site
  • Seoul, Korea, Republic of, 03722
    • Theravance Biopharma Investigational Site
  • Seoul, Korea, Republic of, 02447
    • Theravance Biopharma Investigational Site
  • Gangwon-Do
    • Wŏnju, Gangwon-Do, Korea, Republic of, 26426
      • Theravance Biopharma Investigational Site
  • Gyeonggi-Do
    • Seongnam-si, Gyeonggi-Do, Korea, Republic of, 13496
      • Theravance Biopharma Investigational Site
  • Gyeonggi-do
    • Guri-si, Gyeonggi-do, Korea, Republic of, 11923
      • Theravance Biopharma Investigational Site
• New Zealand
  • Waikato
    • Hamilton, Waikato, New Zealand, 3204
      • Theravance Biopharma Investigational Site
  • Wellington
    • Lower Hutt, Wellington, New Zealand, 5010
      • Theravance Biopharma Investigational Site
• Poland
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 52416
      • Theravance Biopharma Investigational Site
    • Wrocław, Dolnoslaskie, Poland, 53-333
      • Theravance Biopharma Investigational Site
  • Kujawsko-Pomorskie
    • Włocławek, Kujawsko-Pomorskie, Poland, 87-800
      • Theravance Biopharma Investigational Site
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90302
      • Theravance Biopharma Investigational Site
    • Lodz, Lodzkie, Poland, 91363
      • Theravance Biopharma Investigational Site
    • Łódź, Lodzkie, Poland, 91-034
      • Theravance Biopharma Investigational Site
  • Malopolskie
    • Kraków, Malopolskie, Poland, 31501
      • Theravance Biopharma Investigational Site
  • Masovian
    • Warszawa, Masovian, Poland, 00-728
      • Theravance Biopharma Investigational Site
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-653
      • Theravance Biopharma Investigational Site
    • Warszawa, Mazowieckie, Poland, 03-580
      • Theravance Biopharma Investigational Site
    • Warszawa, Mazowieckie, Poland, 00635
      • Theravance Biopharma Investigational Site
    • Warszawa, Mazowieckie, Poland, 02-781
      • Theravance Biopharma Investigational Site
  • Podkarpackie
    • Rzeszow, Podkarpackie, Poland, 35302
      • 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, 61-113
      • Theravance Biopharma Investigational Site
  • Zachodnio-Pomorskie
    • Szczecin, Zachodnio-Pomorskie, Poland, 71434
      • Theravance Biopharma Investigational Site
• Portugal
  • Braga, Portugal, 4700-308
    • Theravance Biopharma Investigational Site
  • Guimarães, Portugal, 4835-044
    • Theravance Biopharma Investigational Site
  • Leiria, Portugal, 2410-197
    • Theravance Biopharma Investigational Site
  • Lisboa, Portugal, 1500-458
    • Theravance Biopharma Investigational Site
  • Santa Maria da Feira, Portugal, 4520-211
    • Theravance Biopharma Investigational Site
  • Setúbal, Portugal, 2910-446
    • Theravance Biopharma Investigational Site
  • Vila Nova De Gaia, Portugal, 4434-502
    • Theravance Biopharma Investigational Site
• Romania
  • Bucuresti, Romania, 050098
    • Theravance Biopharma Investigational Site
  • Cluj, Romania, 400006
    • Theravance Biopharma Investigational Site
  • Bihor
    • Oradea, Bihor, Romania, 410066
      • Theravance Biopharma Investigational Site
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 020125
      • Theravance Biopharma Investigational Site
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400162
      • Theravance Biopharma Investigational Site
  • Timis
    • Timisoara, Timis, Romania, 300167
      • Theravance Biopharma Investigational Site
    • Timişoara, Timis, Romania, 300002
      • Theravance Biopharma Investigational Site
• Russian Federation
  • Novosibirsk, Russian Federation, 630005
    • Theravance Biopharma Investigational Site
  • Novosibirsk, Russian Federation, 630087
    • Theravance Biopharma Investigational Site
  • Saint Petersburg, Russian Federation, 196247
    • Theravance Biopharma Investigational Site
  • Saint-Petersburg, Russian Federation, 195257
    • Theravance Biopharma Investigational Site
  • Saratov, Russian Federation, 410053
    • Theravance Biopharma Investigational Site
  • Moscow City
    • Moscow, Moscow City, Russian Federation, 127015
      • Theravance Biopharma Investigational Site
  • Rostov
    • Rostov-on-Don, Rostov, Russian Federation, 344022
      • Theravance Biopharma Investigational Site
  • Samarskaya Oblast
    • Samara, Samarskaya Oblast, Russian Federation, 443041
      • 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
  • Niš, Serbia, 18000
    • Theravance Biopharma Investigational Site
  • Subotica, Serbia, 24000
    • Theravance Biopharma Investigational Site
  • Zrenjanin, Serbia, 23000
    • Theravance Biopharma Investigational Site
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2196
      • Theravance Biopharma Investigational Site
    • Johannesburg, Gauteng, South Africa, 1619
      • Theravance Biopharma Investigational Site
    • Lenasia, Gauteng, South Africa, 1827
      • Theravance Biopharma Investigational Site
  • Western Cape
    • Claremont, Western Cape, South Africa, 7708
      • Theravance Biopharma Investigational Site
• Spain
  • Barcelona, Spain, 08022
    • Theravance Biopharma Investigational Site
  • Barcelona, Spain, 08036
    • Theravance Biopharma Investigational Site
  • Huelva, Spain, 21005
    • Theravance Biopharma Investigational Site
  • Madrid, Spain, 28922
    • Theravance Biopharma Investigational Site
  • Valencia, Spain, 46010
    • Theravance Biopharma Investigational Site
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35010
      • Theravance Biopharma Investigational Site
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Theravance Biopharma Investigational Site
  • Kharkiv, Ukraine, 61037
    • Theravance Biopharma Investigational Site
  • Kharkiv, Ukraine, 61039
    • Theravance Biopharma Investigational Site
  • Kharkiv, Ukraine, 61137
    • Theravance Biopharma Investigational Site
  • Lviv, Ukraine, 79059
    • Theravance Biopharma Investigational Site
  • Vinnytsia, Ukraine, 21005
    • Theravance Biopharma Investigational Site
  • Zaporizhzhya, Ukraine, 69600
    • Theravance Biopharma Investigational Site
  • Zaporizhzhya, Ukraine, 69104
    • Theravance Biopharma Investigational Site
  • Kiev
    • Kyiv, Kiev, Ukraine, 01133
      • Theravance Biopharma Investigational Site
  • Kiev City
    • Kiev, Kiev City, Ukraine, 04107
      • Theravance Biopharma Investigational Site
    • Kyiv, Kiev City, Ukraine, 01030
      • 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
• United Kingdom
  • England
    • Blackpool, England, United Kingdom, FY3 8NR
      • Theravance Biopharma Investigational Site
    • London, England, United Kingdom, NW1 2PG
      • Theravance Biopharma Investigational Site
  • Scotland
    • Glasgow, Scotland, United Kingdom, G51 4TF
      • Theravance Biopharma Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-2110
      • Theravance Biopharma Investigational Site
    • Mobile, Alabama, United States, 36688
      • Theravance Biopharma Investigational Site
  • Arizona
    • Scottsdale, Arizona, United States, 85259-5499
      • Theravance Biopharma Investigational Site
  • California
    • La Jolla, California, United States, 92093
      • Theravance Biopharma Investigational Site
    • Los Angeles, California, United States, 90048
      • Theravance Biopharma Investigational Site
    • Oakland, California, United States, 94612
      • Theravance Biopharma Investigational Site
    • Santa Monica, California, United States, 90404
      • Theravance Biopharma Investigational Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Theravance Biopharma Investigational Site
    • Clearwater, Florida, United States, 33765
      • Theravance Biopharma Investigational Site
    • Hialeah, Florida, United States, 33013
      • Theravance Biopharma Investigational Site
    • Hollywood, Florida, United States, 33021
      • Theravance Biopharma Investigational Site
    • Largo, Florida, United States, 33777
      • Theravance Biopharma Investigational Site
    • Miami, Florida, United States, 33135
      • Theravance Biopharma Investigational Site
    • New Port Richey, Florida, United States, 34653
      • Theravance Biopharma Investigational Site
    • Saint Petersburg, Florida, United States, 33710
      • Theravance Biopharma Investigational Site
    • Tampa, Florida, United States, 33603
      • Theravance Biopharma Investigational Site
    • Tampa, Florida, United States, 33606
      • Theravance Biopharma Investigational Site
  • Illinois
    • New Lenox, Illinois, United States, 60451
      • 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
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Theravance Biopharma Investigational Site
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Theravance Biopharma Investigational Site
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Theravance Biopharma Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Theravance Biopharma Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89133
      • Theravance Biopharma Investigational Site
  • New York
    • Utica, New York, United States, 13502
      • Theravance Biopharma Investigational Site
  • North Carolina
    • Gastonia, North Carolina, United States, 28504
      • Theravance Biopharma Investigational Site
    • Greenville, North Carolina, United States, 27834
      • Theravance Biopharma Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Theravance Biopharma Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Theravance Biopharma Investigational Site
    • Uniontown, Pennsylvania, United States, 15401
      • Theravance Biopharma Investigational Site
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Theravance Biopharma Investigational Site
    • Rock Hill, South Carolina, United States, 29732
      • Theravance Biopharma Investigational Site
  • Texas
    • Boerne, Texas, United States, 78006
      • Theravance Biopharma Investigational Site
    • El Paso, Texas, United States, 79936
      • Theravance Biopharma Investigational Site
    • Garland, Texas, United States, 75044
      • Theravance Biopharma Investigational Site
    • Harlingen, Texas, United States, 78550
      • Theravance Biopharma Investigational Site
    • Houston, Texas, United States, 77058
      • Theravance Biopharma Investigational Site
    • San Antonio, Texas, United States, 78215
      • Theravance Biopharma Investigational Site
    • San Antonio, Texas, United States, 78229
      • Theravance Biopharma Investigational Site
    • Southlake, Texas, United States, 76092
      • Theravance Biopharma Investigational Site
    • Spring, Texas, United States, 77386
      • Theravance Biopharma Investigational Site
  • Virginia
    • Lansdowne Town Center, Virginia, United States, 20176
      • 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:

• Is at least 18 years of age at screening
• Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
• Moderately-to-severely active Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
• SES-CD score of ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD]
• Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy, anti-IL-12/23 (anti-interleukin), anti-integrin).
• Additional inclusion criteria apply

Exclusion Criteria:

• Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy
• Has a current bacterial, parasitic, fungal, or viral infection
• Has clinically significant abnormalities in laboratory evaluations
• Prior exposure or potential exposure to a JAK inhibitor that was stopped due to intolerance or lack of efficacy
• Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
• Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
• Additional exclusion criteria apply

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment TD-1473 with Dose A; 1 oral Dose A daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.	Drug: TD-1473; TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.
Active Comparator: Active Treatment TD-1473 with Dose B; 1 oral Dose B daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 at Dose B in the Active Treatment Arm for up to 48 additional weeks.	Drug: TD-1473; TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.
Placebo Comparator: Placebo; 1 oral dose daily of placebo for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.	Drug: TD-1473; TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.; Drug: Placebo; Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score	The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Benchmarks for disease activity as measured by the CDAI were: <150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and >450, very severe disease.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI	The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Benchmarks for disease activity as measured by the CDAI were: <150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and >450, very severe disease. Clinical response was defined as a reduction from baseline of ≥100 points or CDAI <150	Week 12
Number of Participants Who Demonstrated CDAI Clinical Remission	The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Benchmarks for disease activity as measured by the CDAI were: <150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and >450, very severe disease. CDAI clinical remission was defined as a CDAI score less than 150 at Week 12.	Week 12
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12	The SES-CD incorporated 4 descriptors: the ulcer size, the proportion of surface covered by ulcer, the proportion of surface covered by other lesions, and the presence of stenosis. Each descriptor was scored in 5 segments (ileum, right colon, transverse colon, left colon, and rectum). The total score ranged from 0 to 56, with higher scores indicating a worse outcome.	Baseline to Week 12
Number of Participants With Endoscopic Response at Week 12	Endoscopic Response was defined as a reduction of SES-CD score or Endoscopic Remission (defined as SES-CD ≤ 2) at Week 12.	Week 12
Number of Participants With Stool Frequency and Abdominal Pain (SFAP) Clinical Remission	SFAP clinical remission was defined as an abdominal pain score ≤1 (on a scale of 0-3 with 0 representing 'no pain' and 3 representing 'severe pain'), stool frequency ≤2.8, and both not worse than baseline at Week 12.	Week 12

Collaborators and Investigators

• Sponsor: Theravance Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; IBD; Crohn's Disease; JAK inhibitor; Janus kinase inhibitor; TD-1473; Intestinal restriction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 0173; 2018-001272-37 (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