AzTrials
AzTrials

Crohn's DiseasePhase 2DIONENCT03635112

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

A Phase 2 study testing TD-1473 in people with Crohn's Disease, run by Theravance Biopharma at 178 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
TD-1473
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
167 participants
Where
178 sitesin 22 countries
Study dates
19 Nov 2018to 30 Dec 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

178 sites in 22 countries.

178 sites in 22 countries

United States44 sites

  • Theravance Biopharma Investigational Site

    Aventura, Florida, 33180

  • Theravance Biopharma Investigational Site

    Birmingham, Alabama, 35233-2110

  • Theravance Biopharma Investigational Site

    Boerne, Texas, 78006

  • Theravance Biopharma Investigational Site

    Brockton, Massachusetts, 02302

  • Theravance Biopharma Investigational Site

    Clearwater, Florida, 33765

  • Theravance Biopharma Investigational Site

    El Paso, Texas, 79936

  • Theravance Biopharma Investigational Site

    Garland, Texas, 75044

  • Theravance Biopharma Investigational Site

    Gastonia, North Carolina, 28504

  • Theravance Biopharma Investigational Site

    Greenville, North Carolina, 27834

  • Theravance Biopharma Investigational Site

    Harlingen, Texas, 78550

  • Theravance Biopharma Investigational Site

    Hialeah, Florida, 33013

  • Theravance Biopharma Investigational Site

    Hollywood, Florida, 33021

  • Theravance Biopharma Investigational Site

    Houston, Texas, 77058

  • Theravance Biopharma Investigational Site

    Kansas City, Kansas, 66160

  • Theravance Biopharma Investigational Site

    La Jolla, California, 92093

  • Theravance Biopharma Investigational Site

    Lansdowne Town Center, Virginia, 20176

  • Theravance Biopharma Investigational Site

    Largo, Florida, 33777

  • Theravance Biopharma Investigational Site

    Las Vegas, Nevada, 89133

  • Theravance Biopharma Investigational Site

    Los Angeles, California, 90048

  • Theravance Biopharma Investigational Site

    Louisville, Kentucky, 40202

  • Theravance Biopharma Investigational Site

    Miami, Florida, 33135

  • Theravance Biopharma Investigational Site

    Mobile, Alabama, 36688

  • Theravance Biopharma Investigational Site

    New Lenox, Illinois, 60451

  • Theravance Biopharma Investigational Site

    New Port Richey, Florida, 34653

  • Theravance Biopharma Investigational Site

    Oakland, California, 94612

  • Theravance Biopharma Investigational Site

    Orangeburg, South Carolina, 29118

  • Theravance Biopharma Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • Theravance Biopharma Investigational Site

    Rock Hill, South Carolina, 29732

  • Theravance Biopharma Investigational Site

    Rockville, Maryland, 20850

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Theravance Biopharma Investigational Site

    San Antonio, Texas, 78215

  • Theravance Biopharma Investigational Site

    San Antonio, Texas, 78229

  • Theravance Biopharma Investigational Site

    Santa Monica, California, 90404

  • Theravance Biopharma Investigational Site

    Scottsdale, Arizona, 85259-5499

  • Theravance Biopharma Investigational Site

    Southlake, Texas, 76092

  • Theravance Biopharma Investigational Site

    Spring, Texas, 77386

  • Theravance Biopharma Investigational Site

    St Louis, Missouri, 63110

  • Theravance Biopharma Investigational Site

    St. Petersburg, Florida, 33710

  • Theravance Biopharma Investigational Site

    Tampa, Florida, 33603

  • Theravance Biopharma Investigational Site

    Tampa, Florida, 33606

  • Theravance Biopharma Investigational Site

    Tulsa, Oklahoma, 74136

  • Theravance Biopharma Investigational Site

    Uniontown, Pennsylvania, 15401

  • Theravance Biopharma Investigational Site

    Utica, New York, 13502

  • Theravance Biopharma Investigational Site

    Wyoming, Michigan, 49519

Other trials in United States

Poland17 sites

  • Theravance Biopharma Investigational Site

    Krakow, Lesser Poland Voivodeship, 31501

  • Theravance Biopharma Investigational Site

    Lodz, Łódź Voivodeship, 90302

  • Theravance Biopharma Investigational Site

    Lodz, Łódź Voivodeship, 91-034

  • Theravance Biopharma Investigational Site

    Lodz, Łódź Voivodeship, 91363

  • Theravance Biopharma Investigational Site

    Poznan, Greater Poland Voivodeship, 61-113

  • Theravance Biopharma Investigational Site

    Rzeszów, Podkarpackie Voivodeship, 35302

  • Theravance Biopharma Investigational Site

    Sopot, Pomeranian Voivodeship, 81-756

  • Theravance Biopharma Investigational Site

    Szczecin, Zachodnio-Pomorskie, 71434

  • Theravance Biopharma Investigational Site

    Tychy, Silesian Voivodeship, 43 100

  • Theravance Biopharma Investigational Site

    Warsaw, Masovian Voivodeship, 00-728

  • Theravance Biopharma Investigational Site

    Warsaw, Masovian Voivodeship, 00635

  • Theravance Biopharma Investigational Site

    Warsaw, Masovian Voivodeship, 02-653

  • Theravance Biopharma Investigational Site

    Warsaw, Masovian Voivodeship, 02-781

  • Theravance Biopharma Investigational Site

    Warsaw, Masovian Voivodeship, 03-580

  • Theravance Biopharma Investigational Site

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800

  • Theravance Biopharma Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 52416

  • Theravance Biopharma Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 53-333

Other trials in Poland

Ukraine14 sites

  • Theravance Biopharma Investigational Site

    Chernivtsi, 58001

  • Theravance Biopharma Investigational Site

    Kharkiv, 61037

  • Theravance Biopharma Investigational Site

    Kharkiv, 61039

  • Theravance Biopharma Investigational Site

    Kharkiv, 61137

  • Theravance Biopharma Investigational Site

    Kiev, KIEV CITY, 04107

  • Theravance Biopharma Investigational Site

    Kremenchuk, Poltava Oblast, 39617

  • Theravance Biopharma Investigational Site

    Kyiv, KIEV CITY, 01030

  • Theravance Biopharma Investigational Site

    Kyiv, Kyiv City, 01133

  • Theravance Biopharma Investigational Site

    Lviv, 79059

  • Theravance Biopharma Investigational Site

    Uzhhorod, Transcarpathian, 88000

  • Theravance Biopharma Investigational Site

    Uzhhorod, Zakarpattia Oblast, 88009

  • Theravance Biopharma Investigational Site

    Vinnytsia, 21005

  • Theravance Biopharma Investigational Site

    Zaporizhzhya, 69104

  • Theravance Biopharma Investigational Site

    Zaporizhzhya, 69600

Other trials in Ukraine

Bulgaria12 sites

  • Theravance Biopharma Investigational Site

    Dobrich, 9300

  • Theravance Biopharma Investigational Site

    Plovdiv, 4004

  • Theravance Biopharma Investigational Site

    Sliven, 8800

  • Theravance Biopharma Investigational Site

    Sofia, Sofia, 1303

  • Theravance Biopharma Investigational Site

    Sofia, Sofia, 1336

  • Theravance Biopharma Investigational Site

    Sofia, Sofia, 1431

  • Theravance Biopharma Investigational Site

    Sofia, Sofia, 1527

  • Theravance Biopharma Investigational Site

    Sofia, Sofia, 1784

  • Theravance Biopharma Investigational Site

    Stara Zagora, 6000

  • Theravance Biopharma Investigational Site

    Stara Zagora, 6001

  • Theravance Biopharma Investigational Site

    Targovishte, Targovishte, 7700

  • Theravance Biopharma Investigational Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Israel9 sites

  • Theravance Biopharma Investigational Site

    Be’er Ya‘aqov, Rehoboth, 7030000

  • Theravance Biopharma Investigational Site

    Haifa, 3339419

  • Theravance Biopharma Investigational Site

    Holon, 5822012

  • Theravance Biopharma Investigational Site

    Jerusalem, 9362410

  • Theravance Biopharma Investigational Site

    Kfar Saba, Sharon, 4428164

  • Theravance Biopharma Investigational Site

    Nahariya, 2210001

  • Theravance Biopharma Investigational Site

    Petah Tikva, 4941492

  • Theravance Biopharma Investigational Site

    Rehovot, Rehoboth, 7661041

  • Theravance Biopharma Investigational Site

    Tel Aviv, 6423906

Other trials in Israel

France8 sites

  • Theravance Biopharma Investigational Site

    Clichy, 92110

  • Theravance Biopharma Investigational Site

    Colombes, Île-de-France Region, 92701

  • Theravance Biopharma Investigational Site

    Nice, Provence-Alpes-Côte d'Azur Region, 06202

  • Theravance Biopharma Investigational Site

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Theravance Biopharma Investigational Site

    Reims, Champagne-ardenne, 51092

  • Theravance Biopharma Investigational Site

    Saint-Etienne, Auvergne, 42055

  • Theravance Biopharma Investigational Site

    Toulouse, Midi-pyrenees, 31059

  • Theravance Biopharma Investigational Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Russia8 sites

  • Theravance Biopharma Investigational Site

    Moscow, Moscow City, 127015

  • Theravance Biopharma Investigational Site

    Novosibirsk, 630005

  • Theravance Biopharma Investigational Site

    Novosibirsk, 630087

  • Theravance Biopharma Investigational Site

    Rostov-on-Don, Rostov Oblast, 344022

  • Theravance Biopharma Investigational Site

    Saint Petersburg, 195257

  • Theravance Biopharma Investigational Site

    Saint Petersburg, 196247

  • Theravance Biopharma Investigational Site

    Samara, Samara Oblast, 443041

  • Theravance Biopharma Investigational Site

    Saratov, 410053

Other trials in Russia

Portugal7 sites

  • Theravance Biopharma Investigational Site

    Braga, 4700-308

  • Theravance Biopharma Investigational Site

    Guimarães, 4835-044

  • Theravance Biopharma Investigational Site

    Leiria, 2410-197

  • Theravance Biopharma Investigational Site

    Lisbon, 1500-458

  • Theravance Biopharma Investigational Site

    Santa Maria da Feira, 4520-211

  • Theravance Biopharma Investigational Site

    Setúbal, 2910-446

  • Theravance Biopharma Investigational Site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Romania7 sites

  • Theravance Biopharma Investigational Site

    Bucharest, Bucharest, 020125

  • Theravance Biopharma Investigational Site

    Bucharest, 050098

  • Theravance Biopharma Investigational Site

    Cluj-Napoca, Cluj, 400162

  • Theravance Biopharma Investigational Site

    Cluj-Napoca, 400006

  • Theravance Biopharma Investigational Site

    Oradea, Bihor County, 410066

  • Theravance Biopharma Investigational Site

    Timișoara, Timiș County, 300002

  • Theravance Biopharma Investigational Site

    Timișoara, Timiș County, 300167

Other trials in Romania

South Korea7 sites

  • Theravance Biopharma Investigational Site

    Busan, 48108

  • Theravance Biopharma Investigational Site

    Daegu, 42601

  • Theravance Biopharma Investigational Site

    Guri-si, Gyeonggi-do, 11923

  • Theravance Biopharma Investigational Site

    Seongnam-si, Gyeonggi-do, 13496

  • Theravance Biopharma Investigational Site

    Seoul, 02447

  • Theravance Biopharma Investigational Site

    Seoul, 03722

  • Theravance Biopharma Investigational Site

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Germany6 sites

  • Theravance Biopharma Investigational Site

    Berlin, 14050

  • Theravance Biopharma Investigational Site

    Hamburg, 22559

  • Theravance Biopharma Investigational Site

    Hanover, Lower Saxony, 30625

  • Theravance Biopharma Investigational Site

    Kiel, Schleswig-Holstein, 24105

  • Theravance Biopharma Investigational Site

    München, Bavaria, 80331

  • Theravance Biopharma Investigational Site

    München, Bavaria, 81377

Other trials in Germany

Serbia6 sites

  • Theravance Biopharma Investigational Site

    Belgrade, 11000

  • Theravance Biopharma Investigational Site

    Belgrade, 11080

  • Theravance Biopharma Investigational Site

    Kragujevac, 34000

  • Theravance Biopharma Investigational Site

    Niš, 18000

  • Theravance Biopharma Investigational Site

    Subotica, 24000

  • Theravance Biopharma Investigational Site

    Zrenjanin, 23000

Other trials in Serbia

Spain6 sites

  • Theravance Biopharma Investigational Site

    Barcelona, 08022

  • Theravance Biopharma Investigational Site

    Barcelona, 08036

  • Theravance Biopharma Investigational Site

    Huelva, 21005

  • Theravance Biopharma Investigational Site

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Theravance Biopharma Investigational Site

    Madrid, 28922

  • Theravance Biopharma Investigational Site

    Valencia, 46010

Other trials in Spain

Croatia4 sites

  • Theravance Biopharma Investigational Site

    Osijek, County of Osijek-Baranja, 31 000

  • Theravance Biopharma Investigational Site

    Rijeka, 51000

  • Theravance Biopharma Investigational Site

    Split, 21000

  • Theravance Biopharma Investigational Site

    Zagreb, 10000

Other trials in Croatia

Hungary4 sites

  • Theravance Biopharma Investigational Site

    Baja, Bács-Kiskun county, 6500

  • Theravance Biopharma Investigational Site

    Budapest, H-1088

  • Theravance Biopharma Investigational Site

    Debrecen, Hajdú-Bihar, 4032

  • Theravance Biopharma Investigational Site

    Gyöngyös, Heves County, 3200

Other trials in Hungary

South Africa4 sites

  • Theravance Biopharma Investigational Site

    Claremont, Western Cape, 7708

  • Theravance Biopharma Investigational Site

    Johannesburg, Gauteng, 1619

  • Theravance Biopharma Investigational Site

    Johannesburg, Gauteng, 2196

  • Theravance Biopharma Investigational Site

    Lenasia, Gauteng, 1827

Other trials in South Africa

Australia3 sites

  • Theravance Biopharma Investigational Site

    Bankstown, New South Wales, 2200

  • Theravance Biopharma Investigational Site

    Elizabeth Vale, South Australia, 5112

  • Theravance Biopharma Investigational Site

    Perth, Western Australia, 6000

Other trials in Australia

Austria3 sites

  • Theravance Biopharma Investigational Site

    Innsbruck, Tyrol, 6020

  • Theravance Biopharma Investigational Site

    Klagenfurt, Carinthia, 9020

  • Theravance Biopharma Investigational Site

    Vienna, State of Vienna, 1090

Other trials in Austria

United Kingdom3 sites

  • Theravance Biopharma Investigational Site

    Blackpool, England, FY3 8NR

  • Theravance Biopharma Investigational Site

    Glasgow, Scotland, G51 4TF

  • Theravance Biopharma Investigational Site

    London, England, NW1 2PG

Other trials in United Kingdom

Georgia2 sites

  • Theravance Biopharma Investigational Site

    Tbilisi, 0114

  • Theravance Biopharma Investigational Site

    Tbilisi, 0159

Other trials in Georgia

Greece2 sites

  • Theravance Biopharma Investigational Site

    Athens, Attica, 115 27

  • Theravance Biopharma Investigational Site

    Heraklion, Crete, 71110

Other trials in Greece

New Zealand2 sites

  • Theravance Biopharma Investigational Site

    Hamilton, Waikato Region, 3204

  • Theravance Biopharma Investigational Site

    Lower Hutt, Wellington Region, 5010

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Conditions
Crohn's Disease
Being tested
Placebo, TD-1473
Keywords
TD-1473, Janus kinase inhibitor, JAK inhibitor, Inflammatory Bowel Disease, IBD, Crohn's Disease, Intestinal restriction
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.

  • TD-1473Drug

    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.

Study groups in NCT03635112
Study groupRoleWhat they receive
Active Treatment TD-1473 with Dose AActive comparator1 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.
Receives: Drug: TD-1473
Active Treatment TD-1473 with Dose BActive comparator1 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.
Receives: Drug: TD-1473
PlaceboPlacebo comparator1 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.
Receives: Drug: Placebo; Drug: TD-1473

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 12

Secondary outcomes (5)

  1. 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

    Measured: Week 12

  2. 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.

    Measured: Week 12

  3. 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.

    Measured: Baseline to Week 12

  4. 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.

    Measured: Week 12

  5. 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start19 Nov 2018
  3. Primary completion30 Dec 2021
  4. Study completion30 Dec 2021

Why it stopped: The study was terminated by the sponsor on 16 November 2021 after a planned review by the Independent Data Monitoring Committee.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03635112
Sponsor's protocol ID
0173
Other IDs
2018-001272-37, 2018
Acronym
DIONE
Status last verified
Feb 2023
First submitted
31 Jul 2018
Last updated
13 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TD-1473 in people with Crohn's Disease, run by Theravance Biopharma at 178 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Poland, Ukraine, Bulgaria, Israel and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Crohn's Disease Activity Index (CDAI) Score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03635112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.

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