Efficacy & Safety of TD-1473 in Ulcerative Colitis (RHEA)

October 21, 2022 updated by: Theravance Biopharma

A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group 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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 (2)
      • Pleven, Bulgaria, 5800
        • Theravance Biopharma Investigational Site
      • 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-Etienne, 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, 69121
        • Theravance Biopharma Investigational Site
      • Ulm, Baden-wuerttemberg, Germany, 89081
        • Theravance Biopharma Investigational Site
    • Schleswig-holstein
      • Kiel, Schleswig-holstein, Germany, 24105
        • Theravance Biopharma Investigational Site
    • Thuringen
      • Jena, Thuringen, Germany, 07747
        • 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
      • Székesfehérvár, Fejer, Hungary, 8000
        • Theravance Biopharma Investigational Site
    • Hajdu-bihar
      • Debrecen, Hajdu-bihar, Hungary, 4032
        • Theravance Biopharma Investigational Site
    • Tolna
      • Szekszard, Tolna, Hungary, 7100
        • Theravance Biopharma Investigational Site
  • Israel
      • Haifa, Israel, 31048
        • 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
      • Rehovot, 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
      • Fukuyama-Shi, 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
      • Izumiotsu, Osaka, Japan, 595-0027
        • Theravance Biopharma Investigational Site
    • Osaka Fu
      • Fujiidera, Osaka Fu, Japan, 583-0027
        • Theravance Biopharma Investigational Site
    • Saitama
      • Tokorozawa, Saitama, Japan, 359-1114
        • Theravance Biopharma Investigational Site
    • Saitama Ken
      • Ageo, 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, 130-702
        • Theravance Biopharma Investigational Site
      • Seoul, Korea, Republic of, 5505
        • 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
      • Szczecin, Poland, 71-685
        • 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, 87-100
        • Theravance Biopharma Investigational Site
      • Włocławek, Kujawsko-Pomorskie, Poland, 87-800
        • Theravance Biopharma Investigational Site
    • Lodzki
      • Łódź, Lodzki, Poland, 90-302
        • Theravance Biopharma Investigational Site
    • Lodzkie
      • Ksawerów, Lodzkie, Poland, 95-054
        • Theravance Biopharma Investigational Site
      • Łódź, Lodzkie, Poland, 91-034
        • 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
    • Swietokrzyskie
      • Staszów, Swietokrzyskie, Poland, 28-200
        • 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
  • 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, 020125
        • 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
      • Kaohsiung, Taiwan, 83301
        • Theravance Biopharma Investigational Site
      • Taichung, Taiwan, 40210
        • Theravance Biopharma Investigational Site
      • Tainan, Taiwan, 71004
        • Theravance Biopharma Investigational Site
      • Taipei, Taiwan, 116
        • 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, 20129
        • 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
      • Úzhgorod, Ukraine, 88009
        • 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
    • 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
  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Theravance Biopharma Investigational Site
      • La Jolla, California, United States, 92037
        • 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
    • New York
      • New York, New York, United States, 10029
        • 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, 37212
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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
  • 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 ≥2 points and an adapted Mayo score between 4 - 9 points inclusive
  • Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids, immunomodulators) or biologics
  • Willing to use highly-effective methods of contraception during the study and for 7 days after the last dose
  • Additional inclusion criteria apply

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 within specified 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 potential exposure to an investigational JAK inhibitor that was stopped due to intolerance or lack of efficacy
  • Additional exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Treatment TD-1473 Dose A
Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.
Drug: TD-1473 Dose A
See Arm description
Experimental: Active Treatment TD-1473 Dose B
Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.
Drug: TD-1473 Dose B
See Arm description
Experimental: Active Treatment TD-1473 Dose C
Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.
Drug: TD-1473 Dose C
See Arm description
Placebo Comparator: Placebo
Participants will be randomized to receive an oral daily dose of placebo. Participants who received Placebo (and were non-responders) may move to an extended induction. Subjects who are on placebo will be assigned to active TD-1473 for the extended induction (they will be blinded to dose).
Drug: Placebo
See Arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Mayo Score (tMS) at Week 8
Time Frame: Baseline to Week 8
Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.
Baseline to Week 8
Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44
Time Frame: mWeek 44

Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.

The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.

Participants with missing Week 44 values were imputed as non-responders.
mWeek 44

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8
Time Frame: Week 8

Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1.

The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.
Week 8
Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44
Time Frame: Baseline to mWeek 44

Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 1.

The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.

Participants with missing Week 44 values were imputed as non-responders.
Baseline to mWeek 44
Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44
Time Frame: mWeek 44

Endoscopic remission was defined as an endoscopic subscore ≤ 1.

Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.
mWeek 44
Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44
Time Frame: mWeek 44

Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0.

Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity.

Participants with missing Week 44 values were imputed as non-responders.
mWeek 44

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2019

Primary Completion (Actual)

October 20, 2021

Study Completion (Actual)

October 20, 2021

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0157
  • 2018-002136-24 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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