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NCT03635112 Clinical Trial

Efficacy and Safety of TD-1473 in Crohn's Disease

Crohn's Disease Clinical Trial

— DIONE  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03635112
Other study ID # 0173
Secondary ID 2018-001272-37
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 19, 2018
Est. completion date December 30, 2021

Study information
Verified date February 2023
Source Theravance Biopharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

A Phase 2 multi-center, randomized, double blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 12 weeks of induction therapy with TD˗1473 in subjects with moderately-to-severely active Crohn's Disease. This study includes 3 phases: Screening, Induction, and Active Treatment Extension (ATE). The Induction phase of the study is a randomized, double blind, placebo controlled, parallel group study evaluating 2 oral dose levels of TD-1473 compared to placebo for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 in the ATE, for up to 48 additional weeks.

Recruitment information / eligibility
Status Terminated
Enrollment 167
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.
• 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.

Locations
Country Name City State
Australia Theravance Biopharma Investigational Site Bankstown New South Wales
Australia Theravance Biopharma Investigational Site Elizabeth Vale South Australia
Australia Theravance Biopharma Investigational Site Perth Western Australia
Austria Theravance Biopharma Investigational Site Innsbruck Tyrol
Austria Theravance Biopharma Investigational Site Klagenfurt am Wörthersee Carinthia
Austria Theravance Biopharma Investigational Site Wien Vienna
Bulgaria Theravance Biopharma Investigational Site Dobrich
Bulgaria Theravance Biopharma Investigational Site Plovdiv
Bulgaria Theravance Biopharma Investigational Site Sliven
Bulgaria Theravance Biopharma Investigational Site Sofia Sofiya
Bulgaria Theravance Biopharma Investigational Site Sofia Sofiya
Bulgaria Theravance Biopharma Investigational Site Sofia Sofiya
Bulgaria Theravance Biopharma Investigational Site Sofia Sofiya
Bulgaria Theravance Biopharma Investigational Site Sofia Sofiya
Bulgaria Theravance Biopharma Investigational Site Stara Zagora
Bulgaria Theravance Biopharma Investigational Site Stara Zagora
Bulgaria Theravance Biopharma Investigational Site Targovishte Turgovishte
Bulgaria Theravance Biopharma Investigational Site Veliko Tarnovo
Croatia Theravance Biopharma Investigational Site Osijek Osijek-baranja
Croatia Theravance Biopharma Investigational Site Rijeka
Croatia Theravance Biopharma Investigational Site Split
Croatia Theravance Biopharma Investigational Site Zagreb
France Theravance Biopharma Investigational Site Clichy
France Theravance Biopharma Investigational Site Colombes Ile-de-france
France Theravance Biopharma Investigational Site Nice Provence Alpes COTE D'azur
France Theravance Biopharma Investigational Site Pierre-Bénite Rhone-alpes
France Theravance Biopharma Investigational Site Reims Champagne-ardenne
France Theravance Biopharma Investigational Site Saint Etienne Auvergne
France Theravance Biopharma Investigational Site Toulouse Midi-pyrenees
France Theravance Biopharma Investigational Site Vandœuvre-lès-Nancy
Georgia Theravance Biopharma Investigational Site Tbilisi
Georgia Theravance Biopharma Investigational Site Tbilisi
Germany Theravance Biopharma Investigational Site Berlin
Germany Theravance Biopharma Investigational Site Hamburg
Germany Theravance Biopharma Investigational Site Hannover Niedersachsen
Germany Theravance Biopharma Investigational Site Kiel Schleswig-holstein
Germany Theravance Biopharma Investigational Site München Bayern
Germany Theravance Biopharma Investigational Site München Bayern
Greece Theravance Biopharma Investigational Site Athens Attica
Greece Theravance Biopharma Investigational Site Heraklion Crete
Hungary Theravance Biopharma Investigational Site Baja Bacs-kiskun
Hungary Theravance Biopharma Investigational Site Budapest
Hungary Theravance Biopharma Investigational Site Debrecen Hajdu-bihar
Hungary Theravance Biopharma Investigational Site Gyöngyös Heves
Israel Theravance Biopharma Investigational Site Be'er Ya'aqov Rehoboth
Israel Theravance Biopharma Investigational Site Haifa
Israel Theravance Biopharma Investigational Site Holon
Israel Theravance Biopharma Investigational Site Jerusalem
Israel Theravance Biopharma Investigational Site Kfar Saba Sharon
Israel Theravance Biopharma Investigational Site Nahariya
Israel Theravance Biopharma Investigational Site Petah Tikva
Israel Theravance Biopharma Investigational Site Rehovot Rehoboth
Israel Theravance Biopharma Investigational Site Tel Aviv
Korea, Republic of Theravance Biopharma Investigational Site Busan
Korea, Republic of Theravance Biopharma Investigational Site Daegu
Korea, Republic of Theravance Biopharma Investigational Site Guri-si Gyeonggi-do
Korea, Republic of Theravance Biopharma Investigational Site Seongnam-si Gyeonggi-Do
Korea, Republic of Theravance Biopharma Investigational Site Seoul
Korea, Republic of Theravance Biopharma Investigational Site Seoul
Korea, Republic of Theravance Biopharma Investigational Site Wonju Gangwon-Do
New Zealand Theravance Biopharma Investigational Site Hamilton Waikato
New Zealand Theravance Biopharma Investigational Site Lower Hutt Wellington
Poland Theravance Biopharma Investigational Site Kraków Malopolskie
Poland Theravance Biopharma Investigational Site Lodz Lodzkie
Poland Theravance Biopharma Investigational Site Lodz Lodzkie
Poland Theravance Biopharma Investigational Site Lódz Lodzkie
Poland Theravance Biopharma Investigational Site Poznan Wielkopolskie
Poland Theravance Biopharma Investigational Site Rzeszow Podkarpackie
Poland Theravance Biopharma Investigational Site Sopot Pomorskie
Poland Theravance Biopharma Investigational Site Szczecin Zachodnio-Pomorskie
Poland Theravance Biopharma Investigational Site Tychy Slaskie
Poland Theravance Biopharma Investigational Site Warszawa Masovian
Poland Theravance Biopharma Investigational Site Warszawa Mazowieckie
Poland Theravance Biopharma Investigational Site Warszawa Mazowieckie
Poland Theravance Biopharma Investigational Site Warszawa Mazowieckie
Poland Theravance Biopharma Investigational Site Warszawa Mazowieckie
Poland Theravance Biopharma Investigational Site Wloclawek Kujawsko-Pomorskie
Poland Theravance Biopharma Investigational Site Wroclaw Dolnoslaskie
Poland Theravance Biopharma Investigational Site Wroclaw Dolnoslaskie
Portugal Theravance Biopharma Investigational Site Braga
Portugal Theravance Biopharma Investigational Site Guimarães
Portugal Theravance Biopharma Investigational Site Leiria
Portugal Theravance Biopharma Investigational Site Lisboa
Portugal Theravance Biopharma Investigational Site Santa Maria da Feira
Portugal Theravance Biopharma Investigational Site Setúbal
Portugal Theravance Biopharma Investigational Site Vila Nova De Gaia
Romania Theravance Biopharma Investigational Site Bucharest Bucuresti
Romania Theravance Biopharma Investigational Site Bucuresti
Romania Theravance Biopharma Investigational Site Cluj
Romania Theravance Biopharma Investigational Site Cluj-Napoca Cluj
Romania Theravance Biopharma Investigational Site Oradea Bihor
Romania Theravance Biopharma Investigational Site Timisoara Timis
Romania Theravance Biopharma Investigational Site Timisoara Timis
Russian Federation Theravance Biopharma Investigational Site Moscow Moscow City
Russian Federation Theravance Biopharma Investigational Site Novosibirsk
Russian Federation Theravance Biopharma Investigational Site Novosibirsk
Russian Federation Theravance Biopharma Investigational Site Rostov-on-Don Rostov
Russian Federation Theravance Biopharma Investigational Site Saint Petersburg
Russian Federation Theravance Biopharma Investigational Site Saint-Petersburg
Russian Federation Theravance Biopharma Investigational Site Samara Samarskaya Oblast
Russian Federation Theravance Biopharma Investigational Site Saratov
Serbia Theravance Biopharma Investigational Site Belgrade
Serbia Theravance Biopharma Investigational Site Belgrade
Serbia Theravance Biopharma Investigational Site Kragujevac
Serbia Theravance Biopharma Investigational Site Niš
Serbia Theravance Biopharma Investigational Site Subotica
Serbia Theravance Biopharma Investigational Site Zrenjanin
South Africa Theravance Biopharma Investigational Site Claremont Western Cape
South Africa Theravance Biopharma Investigational Site Johannesburg Gauteng
South Africa Theravance Biopharma Investigational Site Johannesburg Gauteng
South Africa Theravance Biopharma Investigational Site Lenasia Gauteng
Spain Theravance Biopharma Investigational Site Barcelona
Spain Theravance Biopharma Investigational Site Barcelona
Spain Theravance Biopharma Investigational Site Huelva
Spain Theravance Biopharma Investigational Site Las Palmas De Gran Canaria Las Palmas
Spain Theravance Biopharma Investigational Site Madrid
Spain Theravance Biopharma Investigational Site Valencia
Ukraine Theravance Biopharma Investigational Site Chernivtsi
Ukraine Theravance Biopharma Investigational Site Kharkiv
Ukraine Theravance Biopharma Investigational Site Kharkiv
Ukraine Theravance Biopharma Investigational Site Kharkiv
Ukraine Theravance Biopharma Investigational Site Kiev Kiev City
Ukraine Theravance Biopharma Investigational Site Kremenchuk Poltava
Ukraine Theravance Biopharma Investigational Site Kyiv Kiev City
Ukraine Theravance Biopharma Investigational Site Kyiv Kiev
Ukraine Theravance Biopharma Investigational Site Lviv
Ukraine Theravance Biopharma Investigational Site Úzhgorod Transcarpathian
Ukraine Theravance Biopharma Investigational Site Úzhgorod Transcarpathia
Ukraine Theravance Biopharma Investigational Site Vinnytsia
Ukraine Theravance Biopharma Investigational Site Zaporizhzhya
Ukraine Theravance Biopharma Investigational Site Zaporizhzhya
United Kingdom Theravance Biopharma Investigational Site Blackpool England
United Kingdom Theravance Biopharma Investigational Site Glasgow Scotland
United Kingdom Theravance Biopharma Investigational Site London England
United States Theravance Biopharma Investigational Site Aventura Florida
United States Theravance Biopharma Investigational Site Birmingham Alabama
United States Theravance Biopharma Investigational Site Boerne Texas
United States Theravance Biopharma Investigational Site Brockton Massachusetts
United States Theravance Biopharma Investigational Site Clearwater Florida
United States Theravance Biopharma Investigational Site El Paso Texas
United States Theravance Biopharma Investigational Site Garland Texas
United States Theravance Biopharma Investigational Site Gastonia North Carolina
United States Theravance Biopharma Investigational Site Greenville North Carolina
United States Theravance Biopharma Investigational Site Harlingen Texas
United States Theravance Biopharma Investigational Site Hialeah Florida
United States Theravance Biopharma Investigational Site Hollywood Florida
United States Theravance Biopharma Investigational Site Houston Texas
United States Theravance Biopharma Investigational Site Kansas City Kansas
United States Theravance Biopharma Investigational Site La Jolla California
United States Theravance Biopharma Investigational Site Lansdowne Town Center Virginia
United States Theravance Biopharma Investigational Site Largo Florida
United States Theravance Biopharma Investigational Site Las Vegas Nevada
United States Theravance Biopharma Investigational Site Los Angeles California
United States Theravance Biopharma Investigational Site Louisville Kentucky
United States Theravance Biopharma Investigational Site Miami Florida
United States Theravance Biopharma Investigational Site Mobile Alabama
United States Theravance Biopharma Investigational Site New Lenox Illinois
United States Theravance Biopharma Investigational Site New Port Richey Florida
United States Theravance Biopharma Investigational Site Oakland California
United States Theravance Biopharma Investigational Site Orangeburg South Carolina
United States Theravance Biopharma Investigational Site Pittsburgh Pennsylvania
United States Theravance Biopharma Investigational Site Rock Hill South Carolina
United States Theravance Biopharma Investigational Site Rockville Maryland
United States Theravance Biopharma Investigational Site Saint Louis Missouri
United States Theravance Biopharma Investigational Site Saint Petersburg Florida
United States PMG Research of Salisbury Salisbury North Carolina
United States Theravance Biopharma Investigational Site San Antonio Texas
United States Theravance Biopharma Investigational Site San Antonio Texas
United States Theravance Biopharma Investigational Site Santa Monica California
United States Theravance Biopharma Investigational Site Scottsdale Arizona
United States Theravance Biopharma Investigational Site Southlake Texas
United States Theravance Biopharma Investigational Site Spring Texas
United States Theravance Biopharma Investigational Site Tampa Florida
United States Theravance Biopharma Investigational Site Tampa Florida
United States Theravance Biopharma Investigational Site Tulsa Oklahoma
United States Theravance Biopharma Investigational Site Uniontown Pennsylvania
United States Theravance Biopharma Investigational Site Utica New York
United States Theravance Biopharma Investigational Site Wyoming Michigan

Sponsors (1)
Lead Sponsor Collaborator
Theravance Biopharma

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Bulgaria,  Croatia,  France,  Georgia,  Germany,  Greece,  Hungary,  Israel,  Korea, Republic of,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Crohn's Disease Activity Index (CDAI) Score 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.		 Baseline to Week 12
Secondary Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI 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		 Week 12
Secondary Number of Participants Who Demonstrated CDAI Clinical Remission 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.		 Week 12
Secondary Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 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. Baseline to Week 12
Secondary Number of Participants With Endoscopic Response at Week 12 Endoscopic Response was defined as a reduction of SES-CD score or Endoscopic Remission (defined as SES-CD = 2) at Week 12. Week 12
Secondary Number of Participants With Stool Frequency and Abdominal Pain (SFAP) Clinical Remission 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. Week 12
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