Efficacy & Safety of TD-1473 in Ulcerative Colitis

Last updated: October 21, 2022
Sponsor: Theravance Biopharma
Overall Status: Terminated

Phase

2/3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT03758443
0157
2018-002136-24
  • Ages > 18
  • All Genders

Study Summary

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is at least 18 years of age at screening
  • Has a history of UC for at least 3 months prior to screening
  • Has moderately-to-severely active UC, as defined by a Mayo endoscopic subscore of ≥2points and an adapted Mayo score between 4 - 9 points inclusive
  • Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance toconventional therapy (aminosalicylates, corticosteroids, immunomodulators) orbiologics
  • Willing to use highly-effective methods of contraception during the study and for 7days after the last dose
  • Additional inclusion criteria apply

Exclusion

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 withinspecified timeframe
  • Is refractory to 3 biologics with ≥2 mechanisms of action
  • Has a current bacterial, parasitic, fungal, or viral infection
  • Has clinically significant abnormalities in laboratory evaluations
  • Has had any prior exposure to an approved Janus kinase (JAK) inhibitor or potentialexposure to an investigational JAK inhibitor that was stopped due to intolerance orlack of efficacy
  • Additional exclusion criteria apply

Study Design

Total Participants: 239
Study Start date:
March 11, 2019
Estimated Completion Date:
October 20, 2021

Study Description

This protocol consists of 3 separate studies: an 8-week Phase 2b dose-finding induction study, an 8-week dose-confirming Phase 3 induction study, and a 44-week Phase 3 maintenance study. Subjects who respond to induction will enter the maintenance study; those who do not will receive TD-1473 during extended induction. The safety and efficacy data of the Phase 2b study will be analyzed to select the induction and maintenance dose regimens for the confirmatory Phase 3 studies. Participants who have disease relapse or complete the maintenance study may be eligible to enter a separate long-term safety study. Efficacy, pharmacokinetic, biomarkers, and safety will be evaluated in all 3 studies.

240 subjects are planned for the Phase 2b and the planned Primary Completion Date for this portion of the study is JULY 2021. 640 subjects are planned for the Phase 3 portion of the study.

Connect with a study center

  • Theravance Biopharma Investigational Site

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Sofia, Sofiya 1303
    Bulgaria

    Site Not Available

  • Theravance Biopharma Investigational Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Theravance Biopharma Investigational Site (2)

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Theravance Biopharma Investigational Site

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Theravance Biopharma Investigational Site

    Ruse, 7005
    Bulgaria

    Site Not Available

  • Theravance Biopharma Investigational Site

    Sliven, 8800
    Bulgaria

    Site Not Available

  • Theravance Biopharma Investigational Site

    Stara Zagora, 6001
    Bulgaria

    Site Not Available

  • Theravance Biopharma Investigational Site

    Veliko Tarnovo, 5000
    Bulgaria

    Site Not Available

  • Theravance Biopharma Investigational Site

    Kingston, Ontario K7L 5G2
    Canada

    Site Not Available

  • Theravance Biopharma Investigational Site

    Reims, Champagne-ardenne 51092
    France

    Site Not Available

  • Theravance Biopharma Investigational Site

    Montpellier Cedex 5, Languedoc-roussillon 34295
    France

    Site Not Available

  • Theravance Biopharma Investigational Site

    Vandœuvre-lès-Nancy Cedex, Limousin 54500
    France

    Site Not Available

  • Theravance Biopharma Investigational Site

    Toulouse Cedex 9, Midi-pyrenees 31059
    France

    Site Not Available

  • Theravance Biopharma Investigational Site

    Lille Cedex, NORD Pas-de-calais 59037
    France

    Site Not Available

  • Theravance Biopharma Investigational Site

    Nantes, PAYS DE LA Loire 44000
    France

    Site Not Available

  • Theravance Biopharma Investigational Site

    Amiens Cedex 1, Picardie 80054
    France

    Site Not Available

  • Theravance Biopharma Investigational Site

    Pierre Bénite, Rhone-alpes 69495
    France

    Site Not Available

  • Theravance Biopharma Investigational Site

    Saint-Etienne, Rhone-alpes 42055
    France

    Site Not Available

  • Theravance Biopharma Investigational Site

    Batumi, 6010
    Georgia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Heidelberg, Baden-wuerttemberg 69121
    Germany

    Site Not Available

  • Theravance Biopharma Investigational Site

    Ulm, Baden-wuerttemberg 89081
    Germany

    Site Not Available

  • Theravance Biopharma Investigational Site

    Kiel, Schleswig-holstein 24105
    Germany

    Site Not Available

  • Theravance Biopharma Investigational Site

    Jena, Thuringen 07747
    Germany

    Site Not Available

  • Theravance Biopharma Investigational Site

    Berlin, 13353
    Germany

    Site Not Available

  • Theravance Biopharma Investigational Site

    Athens, Attica 115 27
    Greece

    Site Not Available

  • Theravance Biopharma Investigational Site #2

    Athens, Attica 11527
    Greece

    Site Not Available

  • Theravance Biopharma Investigational Site

    Heraklion, Crete 71110
    Greece

    Site Not Available

  • Theravance Biopharma Investigational Site

    Patra, Peloponnese 265 04
    Greece

    Site Not Available

  • Theravance Biopharma Investigational Site

    Székesfehérvár, Fejer 8000
    Hungary

    Site Not Available

  • Theravance Biopharma Investigational Site

    Debrecen, Hajdu-bihar 4032
    Hungary

    Site Not Available

  • Theravance Biopharma Investigational Site

    Szekszard, Tolna 7100
    Hungary

    Site Not Available

  • Theravance Biopharma Investigational Site

    Budapest, 1136
    Hungary

    Site Not Available

  • Theravance Biopharma Investigational Site

    Zerifin, Rehoboth 7030000
    Israel

    Site Not Available

  • Theravance Biopharma Investigational Site

    Haifa, 31048
    Israel

    Site Not Available

  • Theravance Biopharma Investigational Site

    Holon, 5822012
    Israel

    Site Not Available

  • Theravance Biopharma Investigational Site

    Jerusalem, 9362410
    Israel

    Site Not Available

  • Theravance Biopharma Investigational Site

    Nahariya, 2210001
    Israel

    Site Not Available

  • Theravance Biopharma Investigational Site

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Theravance Biopharma Investigational Site

    Rehovot, 7661041
    Israel

    Site Not Available

  • Theravance Biopharma Investigational Site

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Theravance Biopharma Investigational Site

    Catanzaro, 88100
    Italy

    Site Not Available

  • Theravance Biopharma Investigational Site

    Pavia, 27100
    Italy

    Site Not Available

  • Theravance Biopharma Investigational Site

    Nagoya, Aichi 457-8511
    Japan

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  • Theravance Biopharma Investigational Site

    Abiko, Chiba 270-1168
    Japan

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  • Theravance Biopharma Investigational Site

    Sakura, Chiba 285-8741
    Japan

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  • Theravance Biopharma Investigational Site

    Kurume, Fukuoka 839-0809
    Japan

    Site Not Available

  • Theravance Biopharma Investigational Site

    Ōgaki, Gifu 503-8502
    Japan

    Site Not Available

  • Theravance Biopharma Investigational Site

    Isesaki, Gunma 372-0817
    Japan

    Site Not Available

  • Theravance Biopharma Investigational Site

    Hatsukaichi, Hiroshima 738-8503
    Japan

    Site Not Available

  • Theravance Biopharma Investigational Site

    Fukuyama-Shi, Hiroshima-ken 720-8520
    Japan

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  • Theravance Biopharma Investigational Site

    Kawasaki, Kanagawa 211-8533
    Japan

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  • Theravance Biopharma Investigational Site

    Sendai, Miyagi 981-3213
    Japan

    Site Not Available

  • Theravance Biopharma Investigational Site

    Suwa, Nagano 392-8510
    Japan

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  • Theravance Biopharma Investigational Site

    Ōita, Oita 870-0033
    Japan

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    Izumiotsu, Osaka 595-0027
    Japan

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  • Theravance Biopharma Investigational Site

    Fujiidera, Osaka Fu 583-0027
    Japan

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    Tokorozawa, Saitama 359-1114
    Japan

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  • Theravance Biopharma Investigational Site

    Ageo, Saitama Ken 362-0075
    Japan

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  • Theravance Biopharma Investigational Site

    Ageo Shi, Saitama Ken 362-0075
    Japan

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    Kurobe, Toyama 938-8502
    Japan

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    Chiba, 260-0852
    Japan

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    Fukuoka, 814-0180
    Japan

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  • Theravance Biopharma Investigational Site

    Kumamoto, 860-0004
    Japan

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    Tokyo, 136-0075
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    Wŏnju, Gangwon-do 26426
    Korea, Republic of

    Site Not Available

  • Theravance Biopharma Investigational Site

    Suwon, Gyeonggi-do 16247
    Korea, Republic of

    Site Not Available

  • Theravance Biopharma Investigational Site

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Theravance Biopharma Investigational Site

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Theravance Biopharma Investigational Site

    Wrocław, Dolnoslaskie 53-333
    Poland

    Site Not Available

  • Theravance Biopharma Investigational Site

    Toruń, Kujawsko-Pomorskie 87-100
    Poland

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  • Theravance Biopharma Investigational Site

    Włocławek, Kujawsko-Pomorskie 87-800
    Poland

    Site Not Available

  • Theravance Biopharma Investigational Site

    Ksawerów, Lodzkie 95-054
    Poland

    Site Not Available

  • Theravance Biopharma Investigational Site

    Łódź, Lodzkie 91-034
    Poland

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  • Theravance Biopharma Investigational Site

    Kraków, Malopolskie 31-501
    Poland

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  • Theravance Biopharma Investigational Site

    Piaseczno, Mazowieckie 05-500
    Poland

    Site Not Available

  • Theravance Biopharma Investigational Site

    Warszawa, Mazowieckie 00-728
    Poland

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  • Theravance Biopharma Investigational Site

    Sopot, Pomorskie 81-756
    Poland

    Site Not Available

  • Theravance Biopharma Investigational Site

    Tychy, Slaskie 43-100
    Poland

    Site Not Available

  • Theravance Biopharma Investigational Site

    Staszów, Swietokrzyskie 28-200
    Poland

    Site Not Available

  • Theravance Biopharma Investigational Site

    Poznań, Wielkopolskie 60-369
    Poland

    Site Not Available

  • Theravance Biopharma Investigational Site

    Szczecin, Zachodniopomorskie 71-434
    Poland

    Site Not Available

  • Theravance Biopharma Investigational Site

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Theravance Biopharma Investigational Site

    Guimarães, 4835-044
    Portugal

    Site Not Available

  • Theravance Biopharma Investigational Site

    Leiria, 2410-197
    Portugal

    Site Not Available

  • Theravance Biopharma Investigational Site

    Lisboa, 1349-019
    Portugal

    Site Not Available

  • Theravance Biopharma Investigational Site

    Santa Maria Da Feira, 4520-211
    Portugal

    Site Not Available

  • Theravance Biopharma Investigational Site

    Senhora da Hora, 4454-513
    Portugal

    Site Not Available

  • Theravance Biopharma Investigational Site

    Viana Do Castelo, 4901-858
    Portugal

    Site Not Available

  • Theravance Biopharma Investigational Site

    Vila Nova De Gaia, 4434502
    Portugal

    Site Not Available

  • Theravance Biopharma Investigational Site

    Timişoara, Timis 300002
    Romania

    Site Not Available

  • Theravance Biopharma Investigational Site

    Bucuresti, 020125
    Romania

    Site Not Available

  • Theravance Biopharma Investigational Site

    Belgrade, 11080
    Serbia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Nis, 18000
    Serbia

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  • Theravance Biopharma Investigational Site

    Subotica, 24000
    Serbia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Zrenjanin, 23000
    Serbia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Prešov, Prešovsky 080 01
    Slovakia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Nitra, 949 01
    Slovakia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Šahy, 936 01
    Slovakia

    Site Not Available

  • Theravance Biopharma Investigational Site

    Johannesburg, Gauteng 2196
    South Africa

    Site Not Available

  • Theravance Biopharma Investigational Site

    Barcelona, 08022
    Spain

    Site Not Available

  • Theravance Biopharma Investigational Site

    Madrid, 28006
    Spain

    Site Not Available

  • Theravance Biopharma Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • Theravance Biopharma Investigational Site

    Valencia, 46010
    Spain

    Site Not Available

  • Theravance Biopharma Investigational Site

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Theravance Biopharma Investigational Site

    Taichung, 40210
    Taiwan

    Site Not Available

  • Theravance Biopharma Investigational Site

    Tainan, 71004
    Taiwan

    Site Not Available

  • Theravance Biopharma Investigational Site

    Taipei, 116
    Taiwan

    Site Not Available

  • Theravance Biopharma Investigational Site

    Kyiv, Kiev 4107
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Kiev, Kiev City 04107
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Kremenchuk, Poltava 39617
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Úzhgorod, Transcarpathian 88000
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Vinnytsia, Vinnytsya 21005
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Chernivtsi, 58001
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Lviv, 79010
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site #2

    Lviv, 79010
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Ternopil, 46001
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Zaporizhzhya, 69600
    Ukraine

    Site Not Available

  • Theravance Biopharma Investigational Site

    Chula Vista, California 91911
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    La Jolla, California 92037
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Lancaster, California 93534
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Orange, California 92866
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Colorado Springs, Colorado 80920
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Aventura, Florida 33180
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Largo, Florida 33777
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Miami, Florida 33135
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    New Port Richey, Florida 34653
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    New Smyrna Beach, Florida 32168
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Orlando, Florida 32803
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Brockton, Massachusetts 02302
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Troy, Michigan 48098
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Wyoming, Michigan 48519
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Las Vegas, Nevada 89123
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    New York, New York 10029
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Charlotte, North Carolina 28215
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Smithfield, Pennsylvania 15478
    United States

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  • Theravance Biopharma Investigational Site

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Garland, Texas 75044
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Houston, Texas 77002
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    San Antonio, Texas 78215
    United States

    Site Not Available

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