Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
13/03/2023

Titles & IDs
Public title
Efficacy and Safety of TD-1473 in Crohn's Disease
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
Secondary ID [1] 0 0
2018-001272-37
Secondary ID [2] 0 0
0173
Universal Trial Number (UTN)
Trial acronym
DIONE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Number of Participants Who Demonstrated CDAI Clinical Remission
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Number of Participants With Endoscopic Response at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Number of Participants With Stool Frequency and Abdominal Pain (SFAP) Clinical Remission
Timepoint [5] 0 0
Week 12

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
19/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2021
Sample size
Target
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Theravance Biopharma Investigational Site - Bankstown
Recruitment hospital [2] 0 0
Theravance Biopharma Investigational Site - Elizabeth Vale
Recruitment hospital [3] 0 0
Theravance Biopharma Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Austria
State/province [20] 0 0
Carinthia
Country [21] 0 0
Austria
State/province [21] 0 0
Tyrol
Country [22] 0 0
Austria
State/province [22] 0 0
Vienna
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofiya
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Turgovishte
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Dobrich
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Plovdiv
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Sliven
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Stara Zagora
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Veliko Tarnovo
Country [30] 0 0
Croatia
State/province [30] 0 0
Osijek-baranja
Country [31] 0 0
Croatia
State/province [31] 0 0
Rijeka
Country [32] 0 0
Croatia
State/province [32] 0 0
Split
Country [33] 0 0
Croatia
State/province [33] 0 0
Zagreb
Country [34] 0 0
France
State/province [34] 0 0
Auvergne
Country [35] 0 0
France
State/province [35] 0 0
Champagne-ardenne
Country [36] 0 0
France
State/province [36] 0 0
Ile-de-france
Country [37] 0 0
France
State/province [37] 0 0
Midi-pyrenees
Country [38] 0 0
France
State/province [38] 0 0
Provence Alpes COTE D'azur
Country [39] 0 0
France
State/province [39] 0 0
Rhone-alpes
Country [40] 0 0
France
State/province [40] 0 0
Clichy
Country [41] 0 0
France
State/province [41] 0 0
Vandœuvre-lès-Nancy
Country [42] 0 0
Georgia
State/province [42] 0 0
Tbilisi
Country [43] 0 0
Germany
State/province [43] 0 0
Bayern
Country [44] 0 0
Germany
State/province [44] 0 0
Niedersachsen
Country [45] 0 0
Germany
State/province [45] 0 0
Schleswig-holstein
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Greece
State/province [48] 0 0
Attica
Country [49] 0 0
Greece
State/province [49] 0 0
Crete
Country [50] 0 0
Hungary
State/province [50] 0 0
Bacs-kiskun
Country [51] 0 0
Hungary
State/province [51] 0 0
Hajdu-bihar
Country [52] 0 0
Hungary
State/province [52] 0 0
Heves
Country [53] 0 0
Hungary
State/province [53] 0 0
Budapest
Country [54] 0 0
Israel
State/province [54] 0 0
Rehoboth
Country [55] 0 0
Israel
State/province [55] 0 0
Sharon
Country [56] 0 0
Israel
State/province [56] 0 0
Haifa
Country [57] 0 0
Israel
State/province [57] 0 0
Holon
Country [58] 0 0
Israel
State/province [58] 0 0
Jerusalem
Country [59] 0 0
Israel
State/province [59] 0 0
Nahariya
Country [60] 0 0
Israel
State/province [60] 0 0
Petah Tikva
Country [61] 0 0
Israel
State/province [61] 0 0
Tel Aviv
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Gangwon-Do
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Gyeonggi-do
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Gyeonggi-Do
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Busan
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Daegu
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Seoul
Country [68] 0 0
New Zealand
State/province [68] 0 0
Waikato
Country [69] 0 0
New Zealand
State/province [69] 0 0
Wellington
Country [70] 0 0
Poland
State/province [70] 0 0
Dolnoslaskie
Country [71] 0 0
Poland
State/province [71] 0 0
Kujawsko-Pomorskie
Country [72] 0 0
Poland
State/province [72] 0 0
Lodzkie
Country [73] 0 0
Poland
State/province [73] 0 0
Malopolskie
Country [74] 0 0
Poland
State/province [74] 0 0
Masovian
Country [75] 0 0
Poland
State/province [75] 0 0
Mazowieckie
Country [76] 0 0
Poland
State/province [76] 0 0
Podkarpackie
Country [77] 0 0
Poland
State/province [77] 0 0
Pomorskie
Country [78] 0 0
Poland
State/province [78] 0 0
Slaskie
Country [79] 0 0
Poland
State/province [79] 0 0
Wielkopolskie
Country [80] 0 0
Poland
State/province [80] 0 0
Zachodnio-Pomorskie
Country [81] 0 0
Portugal
State/province [81] 0 0
Braga
Country [82] 0 0
Portugal
State/province [82] 0 0
Guimarães
Country [83] 0 0
Portugal
State/province [83] 0 0
Leiria
Country [84] 0 0
Portugal
State/province [84] 0 0
Lisboa
Country [85] 0 0
Portugal
State/province [85] 0 0
Santa Maria da Feira
Country [86] 0 0
Portugal
State/province [86] 0 0
Setúbal
Country [87] 0 0
Portugal
State/province [87] 0 0
Vila Nova De Gaia
Country [88] 0 0
Romania
State/province [88] 0 0
Bihor
Country [89] 0 0
Romania
State/province [89] 0 0
Bucuresti
Country [90] 0 0
Romania
State/province [90] 0 0
Cluj
Country [91] 0 0
Romania
State/province [91] 0 0
Timis
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Moscow City
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Rostov
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Samarskaya Oblast
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Novosibirsk
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Saint Petersburg
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Saint-Petersburg
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Saratov
Country [99] 0 0
Serbia
State/province [99] 0 0
Belgrade
Country [100] 0 0
Serbia
State/province [100] 0 0
Kragujevac
Country [101] 0 0
Serbia
State/province [101] 0 0
Niš
Country [102] 0 0
Serbia
State/province [102] 0 0
Subotica
Country [103] 0 0
Serbia
State/province [103] 0 0
Zrenjanin
Country [104] 0 0
South Africa
State/province [104] 0 0
Gauteng
Country [105] 0 0
South Africa
State/province [105] 0 0
Western Cape
Country [106] 0 0
Spain
State/province [106] 0 0
Las Palmas
Country [107] 0 0
Spain
State/province [107] 0 0
Barcelona
Country [108] 0 0
Spain
State/province [108] 0 0
Huelva
Country [109] 0 0
Spain
State/province [109] 0 0
Madrid
Country [110] 0 0
Spain
State/province [110] 0 0
Valencia
Country [111] 0 0
Ukraine
State/province [111] 0 0
Kiev City
Country [112] 0 0
Ukraine
State/province [112] 0 0
Kiev
Country [113] 0 0
Ukraine
State/province [113] 0 0
Poltava
Country [114] 0 0
Ukraine
State/province [114] 0 0
Transcarpathian
Country [115] 0 0
Ukraine
State/province [115] 0 0
Transcarpathia
Country [116] 0 0
Ukraine
State/province [116] 0 0
Chernivtsi
Country [117] 0 0
Ukraine
State/province [117] 0 0
Kharkiv
Country [118] 0 0
Ukraine
State/province [118] 0 0
Lviv
Country [119] 0 0
Ukraine
State/province [119] 0 0
Vinnytsia
Country [120] 0 0
Ukraine
State/province [120] 0 0
Zaporizhzhya
Country [121] 0 0
United Kingdom
State/province [121] 0 0
England
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Scotland

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03635112
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03635112