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

Primary Purpose

Ulcerative Colitis (UC)

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

TD-1473 Dose A

TD-1473 Dose B

TD-1473 Dose C

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring TD-1473, Janus kinase inhibitor, JAK inhibitor, Inflammatory Bowel Disease, IBD, Ulcerative colitis, UC, Gut selective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Treatment TD-1473 Dose A

Active Treatment TD-1473 Dose B

Active Treatment TD-1473 Dose C

Placebo

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change From Baseline in Total Mayo Score (tMS) at 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.

Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (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.

Secondary Outcome Measures

Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8

Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at 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.

Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at 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.

Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at 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.

Full Information

NCT ID

NCT03758443

First Posted

November 19, 2018

Last Updated

October 21, 2022

Sponsor

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT03758443

Brief Title

Efficacy & Safety of TD-1473 in Ulcerative Colitis

Acronym

RHEA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.

Study Start Date

March 11, 2019 (Actual)

Primary Completion Date

October 20, 2021 (Actual)

Study Completion Date

October 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theravance Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis (UC)

Keywords

TD-1473, Janus kinase inhibitor, JAK inhibitor, Inflammatory Bowel Disease, IBD, Ulcerative colitis, UC, Gut selective

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Integrated and Adaptive Design

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Treatment TD-1473 Dose A

Arm Type

Experimental

Arm Description

Arm Title

Active Treatment TD-1473 Dose B

Arm Type

Experimental

Arm Description

Arm Title

Active Treatment TD-1473 Dose C

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

TD-1473 Dose A

Intervention Description

See Arm description

Intervention Type

Drug

Intervention Name(s)

TD-1473 Dose B

Intervention Description

See Arm description

Intervention Type

Drug

Intervention Name(s)

TD-1473 Dose C

Intervention Description

See Arm description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

See Arm description

Primary Outcome Measure Information:

Title

Change From Baseline in Total Mayo Score (tMS) at Week 8

Description

Time Frame

Baseline to Week 8

Title

Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44

Description

Time Frame

mWeek 44

Secondary Outcome Measure Information:

Title

Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8

Description

Time Frame

Week 8

Title

Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44

Description

Time Frame

Baseline to mWeek 44

Title

Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44

Description

Endoscopic remission was defined as an endoscopic subscore ≤ 1. Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.

Time Frame

mWeek 44

Title

Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44

Description

Time Frame

mWeek 44

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Theravance Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

Theravance Biopharma Investigational Site

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92866

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80920

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Largo

State/Province

Florida

ZIP/Postal Code

33777

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34653

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

New Smyrna Beach

State/Province

Florida

ZIP/Postal Code

32168

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Wyoming

State/Province

Michigan

ZIP/Postal Code

48519

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64131

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89123

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28215

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Gastonia

State/Province

North Carolina

ZIP/Postal Code

28054

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834-3761

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Smithfield

State/Province

Pennsylvania

ZIP/Postal Code

15478

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Garland

State/Province

Texas

ZIP/Postal Code

75044

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77002

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Theravance Biopharma Investigational Site

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Theravance Biopharma Investigational Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Theravance Biopharma Investigational Site

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Theravance Biopharma Investigational Site

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Theravance Biopharma Investigational Site

City

Sofia

State/Province

Sofiya

ZIP/Postal Code

1303

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Sofia

State/Province

Sofiya

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Sofia

State/Province

Sofiya

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site (2)

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Ruse

ZIP/Postal Code

7005

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Sliven

ZIP/Postal Code

8800

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Sofia

ZIP/Postal Code

1712

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Stara Zagora

ZIP/Postal Code

6001

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Theravance Biopharma Investigational Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5G2

Country

Canada

Facility Name

Theravance Biopharma Investigational Site

City

Reims

State/Province

Champagne-ardenne

ZIP/Postal Code

51092

Country

France

Facility Name

Theravance Biopharma Investigational Site

City

Montpellier Cedex 5

State/Province

Languedoc-roussillon

ZIP/Postal Code

34295

Country

France

Facility Name

Theravance Biopharma Investigational Site

City

Vandœuvre-lès-Nancy Cedex

State/Province

Limousin

ZIP/Postal Code

54500

Country

France

Facility Name

Theravance Biopharma Investigational Site

City

Toulouse Cedex 9

State/Province

Midi-pyrenees

ZIP/Postal Code

31059

Country

France

Facility Name

Theravance Biopharma Investigational Site

City

Lille Cedex

State/Province

NORD Pas-de-calais

ZIP/Postal Code

59037

Country

France

Facility Name

Theravance Biopharma Investigational Site

City

Nantes

State/Province

PAYS DE LA Loire

ZIP/Postal Code

44000

Country

France

Facility Name

Theravance Biopharma Investigational Site

City

Amiens Cedex 1

State/Province

Picardie

ZIP/Postal Code

80054

Country

France

Facility Name

Theravance Biopharma Investigational Site

City

Pierre Bénite

State/Province

Rhone-alpes

ZIP/Postal Code

69495

Country

France

Facility Name

Theravance Biopharma Investigational Site

City

Saint-Etienne

State/Province

Rhone-alpes

ZIP/Postal Code

42055

Country

France

Facility Name

Theravance Biopharma Investigational Site

City

Batumi

ZIP/Postal Code

6010

Country

Georgia

Facility Name

Theravance Biopharma Investigational Site

City

Tbilisi

ZIP/Postal Code

0114

Country

Georgia

Facility Name

Theravance Biopharma Investigational Site

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

Theravance Biopharma Investigational Site

City

Heidelberg

State/Province

Baden-wuerttemberg

ZIP/Postal Code

69121

Country

Germany

Facility Name

Theravance Biopharma Investigational Site

City

Ulm

State/Province

Baden-wuerttemberg

ZIP/Postal Code

89081

Country

Germany

Facility Name

Theravance Biopharma Investigational Site

City

Kiel

State/Province

Schleswig-holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Theravance Biopharma Investigational Site

City

Jena

State/Province

Thuringen

ZIP/Postal Code

07747

Country

Germany

Facility Name

Theravance Biopharma Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Theravance Biopharma Investigational Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Theravance Biopharma Investigational Site

City

Athens

State/Province

Attica

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Theravance Biopharma Investigational Site #2

City

Athens

State/Province

Attica

ZIP/Postal Code

11527

Country

Greece

Facility Name

Theravance Biopharma Investigational Site

City

Heraklion

State/Province

Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

Theravance Biopharma Investigational Site

City

Patra

State/Province

Peloponnese

ZIP/Postal Code

265 04

Country

Greece

Facility Name

Theravance Biopharma Investigational Site

City

Székesfehérvár

State/Province

Fejer

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Theravance Biopharma Investigational Site

City

Debrecen

State/Province

Hajdu-bihar

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Theravance Biopharma Investigational Site

City

Szekszard

State/Province

Tolna

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Theravance Biopharma Investigational Site

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

Theravance Biopharma Investigational Site

City

Budapest

ZIP/Postal Code

1136

Country

Hungary

Facility Name

Theravance Biopharma Investigational Site

City

Zerifin

State/Province

Rehoboth

ZIP/Postal Code

7030000

Country

Israel

Facility Name

Theravance Biopharma Investigational Site

City

Haifa

ZIP/Postal Code

31048

Country

Israel

Facility Name

Theravance Biopharma Investigational Site

City

Holon

ZIP/Postal Code

5822012

Country

Israel

Facility Name

Theravance Biopharma Investigational Site

City

Jerusalem

ZIP/Postal Code

9362410

Country

Israel

Facility Name

Theravance Biopharma Investigational Site

City

Nahariya

ZIP/Postal Code

2210001

Country

Israel

Facility Name

Theravance Biopharma Investigational Site

City

Petah Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Theravance Biopharma Investigational Site

City

Rehovot

ZIP/Postal Code

7661041

Country

Israel

Facility Name

Theravance Biopharma Investigational Site

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Theravance Biopharma Investigational Site

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Theravance Biopharma Investigational Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Theravance Biopharma Investigational Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Abiko

State/Province

Chiba

ZIP/Postal Code

270-1168

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Sakura

State/Province

Chiba

ZIP/Postal Code

285-8741

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

839-0809

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Ōgaki

State/Province

Gifu

ZIP/Postal Code

503-8502

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Isesaki

State/Province

Gunma

ZIP/Postal Code

372-0817

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Fukuyama-Shi

State/Province

Hiroshima-ken

ZIP/Postal Code

720-8520

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Hatsukaichi

State/Province

Hiroshima

ZIP/Postal Code

738-8503

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

211-8533

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

981-3213

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Suwa

State/Province

Nagano

ZIP/Postal Code

392-8510

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Ōita

State/Province

Oita

ZIP/Postal Code

870-0033

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Fujiidera

State/Province

Osaka Fu

ZIP/Postal Code

583-0027

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Izumiotsu

State/Province

Osaka

ZIP/Postal Code

595-0027

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Ageo

State/Province

Saitama Ken

ZIP/Postal Code

362-0075

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Tokorozawa

State/Province

Saitama

ZIP/Postal Code

359-1114

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Kurobe

State/Province

Toyama

ZIP/Postal Code

938-8502

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Chiba

ZIP/Postal Code

260-0852

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Kumamoto

ZIP/Postal Code

860-0004

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Tokyo

ZIP/Postal Code

135-8577

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Tokyo

ZIP/Postal Code

136-0075

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Tokyo

ZIP/Postal Code

152-8902

Country

Japan

Facility Name

Theravance Biopharma Investigational Site

City

Wŏnju

State/Province

Gangwon-do

ZIP/Postal Code

26426

Country

Korea, Republic of

Facility Name

Theravance Biopharma Investigational Site

City

Suwon

State/Province

Gyeonggi-do

ZIP/Postal Code

16247

Country

Korea, Republic of

Facility Name

Theravance Biopharma Investigational Site

City

Daegu

ZIP/Postal Code

42415

Country

Korea, Republic of

Facility Name

Theravance Biopharma Investigational Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Theravance Biopharma Investigational Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Theravance Biopharma Investigational Site

City

Seoul

ZIP/Postal Code

130-702

Country

Korea, Republic of

Facility Name

Theravance Biopharma Investigational Site

City

Seoul

ZIP/Postal Code

5505

Country

Korea, Republic of

Facility Name

Theravance Biopharma Investigational Site

City

Wrocław

State/Province

Dolnoslaskie

ZIP/Postal Code

53-333

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Wrocław

State/Province

Dolnoslaskie

ZIP/Postal Code

54-416

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Toruń

State/Province

Kujawsko-Pomorskie

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Włocławek

State/Province

Kujawsko-Pomorskie

ZIP/Postal Code

87-800

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Ksawerów

State/Province

Lodzkie

ZIP/Postal Code

95-054

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Łódź

State/Province

Lodzkie

ZIP/Postal Code

91-034

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Łódź

State/Province

Lodzki

ZIP/Postal Code

90-302

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Kraków

State/Province

Malopolskie

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Piaseczno

State/Province

Mazowieckie

ZIP/Postal Code

05-500

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

00-635

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

00-728

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-653

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

03-580

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Sopot

State/Province

Pomorskie

ZIP/Postal Code

81-756

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Tychy

State/Province

Slaskie

ZIP/Postal Code

43-100

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Staszów

State/Province

Swietokrzyskie

ZIP/Postal Code

28-200

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Poznań

State/Province

Wielkopolskie

ZIP/Postal Code

60-369

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Poznań

State/Province

Wielkopolskie

ZIP/Postal Code

61-113

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Szczecin

State/Province

Zachodniopomorskie

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Szczecin

ZIP/Postal Code

71-685

Country

Poland

Facility Name

Theravance Biopharma Investigational Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Theravance Biopharma Investigational Site

City

Guimarães

ZIP/Postal Code

4835-044

Country

Portugal

Facility Name

Theravance Biopharma Investigational Site

City

Leiria

ZIP/Postal Code

2410-197

Country

Portugal

Facility Name

Theravance Biopharma Investigational Site

City

Lisboa

ZIP/Postal Code

1349-019

Country

Portugal

Facility Name

Theravance Biopharma Investigational Site

City

Santa Maria Da Feira

ZIP/Postal Code

4520-211

Country

Portugal

Facility Name

Theravance Biopharma Investigational Site

City

Senhora da Hora

ZIP/Postal Code

4454-513

Country

Portugal

Facility Name

Theravance Biopharma Investigational Site

City

Viana Do Castelo

ZIP/Postal Code

4901-858

Country

Portugal

Facility Name

Theravance Biopharma Investigational Site

City

Vila Nova De Gaia

ZIP/Postal Code

4434502

Country

Portugal

Facility Name

Theravance Biopharma Investigational Site

City

Timişoara

State/Province

Timis

ZIP/Postal Code

300002

Country

Romania

Facility Name

Theravance Biopharma Investigational Site

City

Bucuresti

ZIP/Postal Code

020125

Country

Romania

Facility Name

Theravance Biopharma Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Theravance Biopharma Investigational Site

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Theravance Biopharma Investigational Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Theravance Biopharma Investigational Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Theravance Biopharma Investigational Site

City

Subotica

ZIP/Postal Code

24000

Country

Serbia

Facility Name

Theravance Biopharma Investigational Site

City

Zrenjanin

ZIP/Postal Code

23000

Country

Serbia

Facility Name

Theravance Biopharma Investigational Site

City

Prešov

State/Province

Prešovsky

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Theravance Biopharma Investigational Site

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Theravance Biopharma Investigational Site

City

Šahy

ZIP/Postal Code

936 01

Country

Slovakia

Facility Name

Theravance Biopharma Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Theravance Biopharma Investigational Site

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

Facility Name

Theravance Biopharma Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Theravance Biopharma Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Theravance Biopharma Investigational Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Theravance Biopharma Investigational Site

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Theravance Biopharma Investigational Site

City

Taichung

ZIP/Postal Code

40210

Country

Taiwan

Facility Name

Theravance Biopharma Investigational Site

City

Tainan

ZIP/Postal Code

71004

Country

Taiwan

Facility Name

Theravance Biopharma Investigational Site

City

Taipei

ZIP/Postal Code

116

Country

Taiwan

Facility Name

Theravance Biopharma Investigational Site

City

Kiev

State/Province

Kiev City

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Kyiv

State/Province

Kiev

ZIP/Postal Code

01030

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Kyiv

State/Province

Kiev

ZIP/Postal Code

4107

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Kremenchuk

State/Province

Poltava

ZIP/Postal Code

39617

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Úzhgorod

State/Province

Transcarpathian

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Vinnytsia

State/Province

Vinnytsya

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Vinnytsia

State/Province

Vinnytsya

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Chernivtsi

ZIP/Postal Code

58001

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Kharkiv

ZIP/Postal Code

61037

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site #2

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Ternopil

ZIP/Postal Code

46001

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Vinnytsia

ZIP/Postal Code

20129

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Zaporizhzhya

ZIP/Postal Code

69096

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Theravance Biopharma Investigational Site

City

Úzhgorod

ZIP/Postal Code

88009

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

Efficacy & Safety of TD-1473 in Ulcerative Colitis

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

Ulcerative Colitis (UC)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial