Clinical trial NCT03635112: Efficacy and Safety of TD-1473 in Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: TD-1473
Janus kinase inhibitor
JAK inhibitor
Inflammatory Bowel Disease
IBD
Crohn's Disease
Intestinal restriction
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2018-08-17
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Crohn's Disease Activity Index (CDAI) Score
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI
timeFrame: Week 12
measure: Number of Participants Who Demonstrated CDAI Clinical Remission
timeFrame: Week 12
measure: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
timeFrame: Baseline to Week 12
measure: Number of Participants With Endoscopic Response at Week 12
timeFrame: Week 12
measure: Number of Participants With Stool Frequency and Abdominal Pain (SFAP) Clinical Remission
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Theravance Biopharma Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Theravance Biopharma Investigational Site
state: Alabama
city: Scottsdale
country: United States
facility: Theravance Biopharma Investigational Site
state: Arizona
city: La Jolla
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facility: Theravance Biopharma Investigational Site
state: California
city: Los Angeles
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facility: Theravance Biopharma Investigational Site
state: California
city: Oakland
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facility: Theravance Biopharma Investigational Site
state: California
city: Santa Monica
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state: Florida
city: Clearwater
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city: Hialeah
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facility: Theravance Biopharma Investigational Site
state: Florida
city: Hollywood
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city: Largo
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city: Miami
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city: New Port Richey
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facility: Theravance Biopharma Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Tampa
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facility: Theravance Biopharma Investigational Site
state: Florida
city: Tampa
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state: Florida
city: New Lenox
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facility: Theravance Biopharma Investigational Site
state: Illinois
city: Kansas City
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facility: Theravance Biopharma Investigational Site
state: Kansas
city: Louisville
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facility: Theravance Biopharma Investigational Site
state: Kentucky
city: Rockville
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facility: Theravance Biopharma Investigational Site
state: Maryland
city: Brockton
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facility: Theravance Biopharma Investigational Site
state: Massachusetts
city: Wyoming
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state: Michigan
city: Saint Louis
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facility: Theravance Biopharma Investigational Site
state: Missouri
city: Las Vegas
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state: Nevada
city: Utica
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facility: Theravance Biopharma Investigational Site
state: New York
city: Gastonia
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state: North Carolina
city: Greenville
country: United States
facility: Theravance Biopharma Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Tulsa
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facility: Theravance Biopharma Investigational Site
state: Oklahoma
city: Pittsburgh
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facility: Theravance Biopharma Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
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state: Pennsylvania
city: Orangeburg
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state: South Carolina
city: Rock Hill
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state: South Carolina
city: Boerne
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facility: Theravance Biopharma Investigational Site
state: Texas
city: El Paso
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facility: Theravance Biopharma Investigational Site
state: Texas
city: Garland
country: United States
facility: Theravance Biopharma Investigational Site
state: Texas
city: Harlingen
country: United States
facility: Theravance Biopharma Investigational Site
state: Texas
city: Houston
country: United States
facility: Theravance Biopharma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Theravance Biopharma Investigational Site
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Southlake
country: United States
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state: Texas
city: Spring
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state: Texas
city: Lansdowne Town Center
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facility: Theravance Biopharma Investigational Site
state: Virginia
city: Bankstown
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facility: Theravance Biopharma Investigational Site
state: New South Wales
city: Elizabeth Vale
country: Australia
facility: Theravance Biopharma Investigational Site
state: South Australia
city: Perth
country: Australia
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state: Western Australia
city: Klagenfurt am Wörthersee
country: Austria
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state: Carinthia
city: Innsbruck
country: Austria
facility: Theravance Biopharma Investigational Site
state: Tyrol
city: Wien
country: Austria
facility: Theravance Biopharma Investigational Site
state: Vienna
city: Sofia
country: Bulgaria
facility: Theravance Biopharma Investigational Site
state: Sofiya
city: Sofia
country: Bulgaria
facility: Theravance Biopharma Investigational Site
state: Sofiya
city: Sofia
country: Bulgaria
facility: Theravance Biopharma Investigational Site
state: Sofiya
city: Sofia
country: Bulgaria
facility: Theravance Biopharma Investigational Site
state: Sofiya
city: Sofia
country: Bulgaria
facility: Theravance Biopharma Investigational Site
state: Sofiya
city: Targovishte
country: Bulgaria
facility: Theravance Biopharma Investigational Site
state: Turgovishte
city: Dobrich
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facility: Theravance Biopharma Investigational Site
city: Plovdiv
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Sliven
country: Bulgaria
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city: Stara Zagora
country: Bulgaria
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city: Stara Zagora
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: Theravance Biopharma Investigational Site
city: Osijek
country: Croatia
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state: Osijek-baranja
city: Rijeka
country: Croatia
facility: Theravance Biopharma Investigational Site
city: Split
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city: Zagreb
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city: Saint Etienne
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facility: Theravance Biopharma Investigational Site
state: Auvergne
city: Reims
country: France
facility: Theravance Biopharma Investigational Site
state: Champagne-ardenne
city: Colombes
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state: Ile-de-france
city: Toulouse
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state: Midi-pyrenees
city: Nice
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facility: Theravance Biopharma Investigational Site
state: Provence Alpes COTE D'azur
city: Pierre-Bénite
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facility: Theravance Biopharma Investigational Site
state: Rhone-alpes
city: Clichy
country: France
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city: Vandœuvre-lès-Nancy
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
facility: Theravance Biopharma Investigational Site
city: München
country: Germany
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state: Bayern
city: München
country: Germany
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state: Bayern
city: Hannover
country: Germany
facility: Theravance Biopharma Investigational Site
state: Niedersachsen
city: Kiel
country: Germany
facility: Theravance Biopharma Investigational Site
state: Schleswig-holstein
city: Berlin
country: Germany
facility: Theravance Biopharma Investigational Site
city: Hamburg
country: Germany
facility: Theravance Biopharma Investigational Site
city: Athens
country: Greece
facility: Theravance Biopharma Investigational Site
state: Attica
city: Heraklion
country: Greece
facility: Theravance Biopharma Investigational Site
state: Crete
city: Baja
country: Hungary
facility: Theravance Biopharma Investigational Site
state: Bacs-kiskun
city: Debrecen
country: Hungary
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state: Hajdu-bihar
city: Gyöngyös
country: Hungary
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state: Heves
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city: Rehovot
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state: Rehoboth
city: Kfar Saba
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city: Haifa
country: Israel
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city: Holon
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city: Jerusalem
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city: Nahariya
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city: Petah Tikva
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city: Tel Aviv
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city: Guri-si
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facility: Theravance Biopharma Investigational Site
state: Gyeonggi-do
city: Seongnam-si
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state: Gyeonggi-Do
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country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Theravance Biopharma Investigational Site
city: Hamilton
country: New Zealand
facility: Theravance Biopharma Investigational Site
state: Waikato
city: Lower Hutt
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state: Wellington
city: Wroclaw
country: Poland
facility: Theravance Biopharma Investigational Site
state: Dolnoslaskie
city: Wrocław
country: Poland
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state: Dolnoslaskie
city: Włocławek
country: Poland
facility: Theravance Biopharma Investigational Site
state: Kujawsko-Pomorskie
city: Lodz
country: Poland
facility: Theravance Biopharma Investigational Site
state: Lodzkie
city: Lodz
country: Poland
facility: Theravance Biopharma Investigational Site
state: Lodzkie
city: Łódź
country: Poland
facility: Theravance Biopharma Investigational Site
state: Lodzkie
city: Kraków
country: Poland
facility: Theravance Biopharma Investigational Site
state: Malopolskie
city: Warszawa
country: Poland
facility: Theravance Biopharma Investigational Site
state: Masovian
city: Warszawa
country: Poland
facility: Theravance Biopharma Investigational Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Theravance Biopharma Investigational Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Theravance Biopharma Investigational Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Theravance Biopharma Investigational Site
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Theravance Biopharma Investigational Site
state: Podkarpackie
city: Sopot
country: Poland
facility: Theravance Biopharma Investigational Site
state: Pomorskie
city: Tychy
country: Poland
facility: Theravance Biopharma Investigational Site
state: Slaskie
city: Poznań
country: Poland
facility: Theravance Biopharma Investigational Site
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Theravance Biopharma Investigational Site
state: Zachodnio-Pomorskie
city: Braga
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Guimarães
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Leiria
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Lisboa
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Santa Maria da Feira
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Setúbal
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Vila Nova De Gaia
country: Portugal
facility: Theravance Biopharma Investigational Site
city: Oradea
country: Romania
facility: Theravance Biopharma Investigational Site
state: Bihor
city: Bucharest
country: Romania
facility: Theravance Biopharma Investigational Site
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Theravance Biopharma Investigational Site
state: Cluj
city: Timisoara
country: Romania
facility: Theravance Biopharma Investigational Site
state: Timis
city: Timişoara
country: Romania
facility: Theravance Biopharma Investigational Site
state: Timis
city: Bucuresti
country: Romania
facility: Theravance Biopharma Investigational Site
city: Cluj
country: Romania
facility: Theravance Biopharma Investigational Site
city: Moscow
country: Russian Federation
facility: Theravance Biopharma Investigational Site
state: Moscow City
city: Rostov-on-Don
country: Russian Federation
facility: Theravance Biopharma Investigational Site
state: Rostov
city: Samara
country: Russian Federation
facility: Theravance Biopharma Investigational Site
state: Samarskaya Oblast
city: Novosibirsk
country: Russian Federation
facility: Theravance Biopharma Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Theravance Biopharma Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Theravance Biopharma Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Theravance Biopharma Investigational Site
city: Saratov
country: Russian Federation
facility: Theravance Biopharma Investigational Site
city: Belgrade
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Belgrade
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Kragujevac
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Niš
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Subotica
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Zrenjanin
country: Serbia
facility: Theravance Biopharma Investigational Site
city: Johannesburg
country: South Africa
facility: Theravance Biopharma Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Theravance Biopharma Investigational Site
state: Gauteng
city: Lenasia
country: South Africa
facility: Theravance Biopharma Investigational Site
state: Gauteng
city: Claremont
country: South Africa
facility: Theravance Biopharma Investigational Site
state: Western Cape
city: Las Palmas De Gran Canaria
country: Spain
facility: Theravance Biopharma Investigational Site
state: Las Palmas
city: Barcelona
country: Spain
facility: Theravance Biopharma Investigational Site
city: Barcelona
country: Spain
facility: Theravance Biopharma Investigational Site
city: Huelva
country: Spain
facility: Theravance Biopharma Investigational Site
city: Madrid
country: Spain
facility: Theravance Biopharma Investigational Site
city: Valencia
country: Spain
facility: Theravance Biopharma Investigational Site
city: Kiev
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Kiev City
city: Kyiv
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Kiev City
city: Kyiv
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Kiev
city: Kremenchuk
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Poltava
city: Úzhgorod
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Transcarpathian
city: Úzhgorod
country: Ukraine
facility: Theravance Biopharma Investigational Site
state: Transcarpathia
city: Chernivtsi
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Kharkiv
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Kharkiv
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Kharkiv
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Lviv
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Vinnytsia
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: Theravance Biopharma Investigational Site
city: Blackpool
country: United Kingdom
facility: Theravance Biopharma Investigational Site
state: England
city: London
country: United Kingdom
facility: Theravance Biopharma Investigational Site
state: England
city: Glasgow
country: United Kingdom
facility: Theravance Biopharma Investigational Site
state: Scotland
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: