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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03758443




Registration number
NCT03758443
Ethics application status
Date submitted
19/11/2018
Date registered
29/11/2018

Titles & IDs
Public title
Efficacy & Safety of TD-1473 in Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
2018-002136-24
Secondary ID [2] 0 0
0157
Universal Trial Number (UTN)
Trial acronym
RHEA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TD-1473 Dose A
Treatment: Drugs - TD-1473 Dose B
Treatment: Drugs - TD-1473 Dose C
Treatment: Drugs - Placebo

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.

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.

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.

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).


Treatment: Drugs: TD-1473 Dose A
See Arm description

Treatment: Drugs: TD-1473 Dose B
See Arm description

Treatment: Drugs: TD-1473 Dose C
See Arm description

Treatment: Drugs: Placebo
See Arm description
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Total Mayo Score (tMS) at Week 8
Timepoint [1] 0 0
Baseline to Week 8
Primary outcome [2] 0 0
Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44
Timepoint [2] 0 0
mWeek 44
Secondary outcome [1] 0 0
Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44
Timepoint [2] 0 0
Baseline to mWeek 44
Secondary outcome [3] 0 0
Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44
Timepoint [3] 0 0
mWeek 44
Secondary outcome [4] 0 0
Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44
Timepoint [4] 0 0
mWeek 44

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/10/2021
Sample size
Target
Accrual to date
Final
239
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Theravance Biopharma Investigational Site - South Brisbane
Recruitment hospital [2] 0 0
Theravance Biopharma Investigational Site - Woolloongabba
Recruitment hospital [3] 0 0
Theravance Biopharma Investigational Site - Malvern
Recruitment hospital [4] 0 0
Theravance Biopharma Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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California
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Colorado
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Florida
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Georgia
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Idaho
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Kansas
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Kentucky
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Louisiana
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Michigan
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Minnesota
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Missouri
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Nevada
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New York
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North Carolina
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Pennsylvania
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South Carolina
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Texas
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Bulgaria
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Sofiya
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Pleven
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Ruse
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Ontario
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Oita
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Osaka Fu
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Osaka
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Gauteng
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Barcelona
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Madrid
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Sevilla
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Spain
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Valencia
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Taiwan
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Kaohsiung
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Taichung
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Tainan
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Taipei
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Ukraine
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Kiev City
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Ukraine
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Kiev
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Ukraine
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Poltava
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Ukraine
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Transcarpathian
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Ukraine
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Vinnytsya
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Ukraine
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Chernivtsi
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Ukraine
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Kharkiv
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Ukraine
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Lviv
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Ukraine
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Ternopil
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhya
Country [132] 0 0
Ukraine
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Úzhgorod

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Theravance Biopharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Theravance Biopharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03758443