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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
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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
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Secondary ID [1]
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2018-002136-24
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Secondary ID [2]
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0157
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Universal Trial Number (UTN)
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Trial acronym
RHEA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC)
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0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Total Mayo Score (tMS) at Week 8
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 8
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Primary outcome [2]
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Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44
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Assessment method [2]
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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.
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Timepoint [2]
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mWeek 44
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Secondary outcome [1]
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Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8
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Assessment method [1]
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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.
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Timepoint [1]
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Week 8
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Secondary outcome [2]
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Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to mWeek 44
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Secondary outcome [3]
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Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44
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Assessment method [3]
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Endoscopic remission was defined as an endoscopic subscore = 1.
Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.
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Timepoint [3]
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mWeek 44
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Secondary outcome [4]
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Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44
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Assessment method [4]
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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.
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Timepoint [4]
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mWeek 44
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/10/2021
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Sample size
Target
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Accrual to date
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Final
239
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Theravance Biopharma Investigational Site - South Brisbane
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Theravance Biopharma Investigational Site - Woolloongabba
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Theravance Biopharma Investigational Site - Murdoch
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4101 - South Brisbane
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4102 - Woolloongabba
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3144 - Malvern
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Spain
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State/province [115]
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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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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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State/province [120]
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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
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Ukraine
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State/province [132]
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Úzhgorod
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Theravance Biopharma
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03758443
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Theravance Biopharma
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Email
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/43/NCT03758443/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/43/NCT03758443/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03758443