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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03635112
Registration number
NCT03635112
Ethics application status
Date submitted
31/07/2018
Date registered
17/08/2018
Titles & IDs
Public title
Efficacy and Safety of TD-1473 in Crohn's Disease
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Scientific title
A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's Disease
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Secondary ID [1]
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2018-001272-37
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Secondary ID [2]
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0173
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Universal Trial Number (UTN)
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Trial acronym
DIONE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
0
0
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Inflammatory bowel disease
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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
0
0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - TD-1473
Active comparator: Active Treatment TD-1473 with Dose A - 1 oral Dose A daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD.
Subjects who complete Induction will continue to receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.
Active comparator: Active Treatment TD-1473 with Dose B - 1 oral Dose B daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD.
Subjects who complete Induction will continue to receive TD-1473 at Dose B in the Active Treatment Arm for up to 48 additional weeks.
Placebo comparator: Placebo - 1 oral dose daily of placebo for 12 weeks in subjects with moderately to-severely active CD.
Subjects who complete Induction will receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.
Treatment: Drugs: Placebo
Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.
Treatment: Drugs: TD-1473
TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.
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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 Crohn's Disease Activity Index (CDAI) Score
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Assessment method [1]
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The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Benchmarks for disease activity as measured by the CDAI were: \<150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and \>450, very severe disease.
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [1]
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Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI
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Assessment method [1]
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The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Benchmarks for disease activity as measured by the CDAI were: \<150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and \>450, very severe disease.
Clinical response was defined as a reduction from baseline of =100 points or CDAI \<150
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Number of Participants Who Demonstrated CDAI Clinical Remission
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Assessment method [2]
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The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Benchmarks for disease activity as measured by the CDAI were: \<150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and \>450, very severe disease.
CDAI clinical remission was defined as a CDAI score less than 150 at Week 12.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
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Assessment method [3]
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The SES-CD incorporated 4 descriptors: the ulcer size, the proportion of surface covered by ulcer, the proportion of surface covered by other lesions, and the presence of stenosis. Each descriptor was scored in 5 segments (ileum, right colon, transverse colon, left colon, and rectum). The total score ranged from 0 to 56, with higher scores indicating a worse outcome.
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Timepoint [3]
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Baseline to Week 12
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Secondary outcome [4]
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Number of Participants With Endoscopic Response at Week 12
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Assessment method [4]
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Endoscopic Response was defined as a reduction of SES-CD score or Endoscopic Remission (defined as SES-CD = 2) at Week 12.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Number of Participants With Stool Frequency and Abdominal Pain (SFAP) Clinical Remission
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Assessment method [5]
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SFAP clinical remission was defined as an abdominal pain score =1 (on a scale of 0-3 with 0 representing 'no pain' and 3 representing 'severe pain'), stool frequency =2.8, and both not worse than baseline at Week 12.
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Timepoint [5]
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Week 12
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Eligibility
Key inclusion criteria
* Is at least 18 years of age at screening
* Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
* Moderately-to-severely active Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
* SES-CD score of = 3 with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD]
* Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy, anti-IL-12/23 (anti-interleukin), anti-integrin).
* 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
* Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy
* Has a current bacterial, parasitic, fungal, or viral infection
* Has clinically significant abnormalities in laboratory evaluations
* Prior exposure or potential exposure to a JAK inhibitor that was stopped due to intolerance or lack of efficacy
* Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
* Subject has failed = 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
* 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
19/11/2018
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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
30/12/2021
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Sample size
Target
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Accrual to date
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Final
167
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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Theravance Biopharma Investigational Site - Bankstown
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Theravance Biopharma Investigational Site - Elizabeth Vale
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Theravance Biopharma Investigational Site - Perth
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2200 - Bankstown
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5112 - Elizabeth Vale
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6000 - Perth
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Huelva
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Spain
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State/province [109]
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Madrid
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Spain
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Valencia
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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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Country [113]
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Ukraine
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Poltava
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Ukraine
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State/province [114]
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Transcarpathian
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Ukraine
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Transcarpathia
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Ukraine
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State/province [116]
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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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Vinnytsia
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Ukraine
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Zaporizhzhya
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United Kingdom
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England
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United Kingdom
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Scotland
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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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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.
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Trial website
https://clinicaltrials.gov/study/NCT03635112
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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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0
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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/12/NCT03635112/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/12/NCT03635112/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03635112