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

NCT ID: NCT03635112

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2021-12-30

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TD-1473

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

TD-1473

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

TD-1473

Intervention Type: DRUG

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.

Interventions

Placebo

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

Intervention Type: DRUG

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 Type: DRUG

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).

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theravance Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

Theravance Biopharma Investigational Site

Birmingham, Alabama, United States

Theravance Biopharma Investigational Site

Mobile, Alabama, United States

Theravance Biopharma Investigational Site

Scottsdale, Arizona, United States

Theravance Biopharma Investigational Site

La Jolla, California, United States

Theravance Biopharma Investigational Site

Los Angeles, California, United States

Theravance Biopharma Investigational Site

Oakland, California, United States

Theravance Biopharma Investigational Site

Santa Monica, California, United States

Theravance Biopharma Investigational Site

Aventura, Florida, United States

Theravance Biopharma Investigational Site

Clearwater, Florida, United States

Theravance Biopharma Investigational Site

Hialeah, Florida, United States

Theravance Biopharma Investigational Site

Hollywood, Florida, United States

Theravance Biopharma Investigational Site

Largo, Florida, United States

Theravance Biopharma Investigational Site

Miami, Florida, United States

Theravance Biopharma Investigational Site

New Port Richey, Florida, United States

Theravance Biopharma Investigational Site

St. Petersburg, Florida, United States

Theravance Biopharma Investigational Site

Tampa, Florida, United States

Theravance Biopharma Investigational Site

Tampa, Florida, United States

Theravance Biopharma Investigational Site

New Lenox, Illinois, United States

Theravance Biopharma Investigational Site

Kansas City, Kansas, United States

Theravance Biopharma Investigational Site

Louisville, Kentucky, United States

Theravance Biopharma Investigational Site

Rockville, Maryland, United States

Theravance Biopharma Investigational Site

Brockton, Massachusetts, United States

Theravance Biopharma Investigational Site

Wyoming, Michigan, United States

Theravance Biopharma Investigational Site

St Louis, Missouri, United States

Theravance Biopharma Investigational Site

Las Vegas, Nevada, United States

Theravance Biopharma Investigational Site

Utica, New York, United States

Theravance Biopharma Investigational Site

Gastonia, North Carolina, United States

Theravance Biopharma Investigational Site

Greenville, North Carolina, United States

PMG Research of Salisbury

Salisbury, North Carolina, United States

Theravance Biopharma Investigational Site

Tulsa, Oklahoma, United States

Theravance Biopharma Investigational Site

Pittsburgh, Pennsylvania, United States

Theravance Biopharma Investigational Site

Uniontown, Pennsylvania, United States

Theravance Biopharma Investigational Site

Orangeburg, South Carolina, United States

Theravance Biopharma Investigational Site

Rock Hill, South Carolina, United States

Theravance Biopharma Investigational Site

Boerne, Texas, United States

Theravance Biopharma Investigational Site

El Paso, Texas, United States

Theravance Biopharma Investigational Site

Garland, Texas, United States

Theravance Biopharma Investigational Site

Harlingen, Texas, United States

Theravance Biopharma Investigational Site

Houston, Texas, United States

Theravance Biopharma Investigational Site

San Antonio, Texas, United States

Theravance Biopharma Investigational Site

San Antonio, Texas, United States

Theravance Biopharma Investigational Site

Southlake, Texas, United States

Theravance Biopharma Investigational Site

Spring, Texas, United States

Theravance Biopharma Investigational Site

Lansdowne Town Center, Virginia, United States

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, Australia

Theravance Biopharma Investigational Site

Klagenfurt, Carinthia, Austria

Theravance Biopharma Investigational Site

Innsbruck, Tyrol, Austria

Theravance Biopharma Investigational Site

Vienna, Vienna, Austria

Theravance Biopharma Investigational Site

Sofia, Sofia, Bulgaria

Theravance Biopharma Investigational Site

Sofia, Sofia, Bulgaria

Theravance Biopharma Investigational Site

Sofia, Sofia, Bulgaria

Theravance Biopharma Investigational Site

Sofia, Sofia, Bulgaria

Theravance Biopharma Investigational Site

Sofia, Sofia, Bulgaria

Theravance Biopharma Investigational Site

Targovishte, Targovishte, Bulgaria

Theravance Biopharma Investigational Site

Dobrich, , Bulgaria

Theravance Biopharma Investigational Site

Plovdiv, , Bulgaria

Theravance Biopharma Investigational Site

Sliven, , Bulgaria

Theravance Biopharma Investigational Site

Stara Zagora, , Bulgaria

Theravance Biopharma Investigational Site

Stara Zagora, , Bulgaria

Theravance Biopharma Investigational Site

Veliko Tarnovo, , Bulgaria

Theravance Biopharma Investigational Site

Osijek, County of Osijek-Baranja, Croatia

Theravance Biopharma Investigational Site

Rijeka, , Croatia

Theravance Biopharma Investigational Site

Split, , Croatia

Theravance Biopharma Investigational Site

Zagreb, , Croatia

Theravance Biopharma Investigational Site

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Theravance Biopharma Investigational Site

Saint-Etienne, Auvergne, France

Theravance Biopharma Investigational Site

Reims, Champagne-ardenne, France

Theravance Biopharma Investigational Site

Toulouse, Midi-pyrenees, France

Theravance Biopharma Investigational Site

Nice, Provence-Alpes-Côte d'Azur Region, France

Theravance Biopharma Investigational Site

Clichy, , France

Theravance Biopharma Investigational Site

Vandœuvre-lès-Nancy, , France

Theravance Biopharma Investigational Site

Colombes, Île-de-France Region, France

Theravance Biopharma Investigational Site

Tbilisi, , Georgia

Theravance Biopharma Investigational Site

Tbilisi, , Georgia

Theravance Biopharma Investigational Site

München, Bavaria, Germany

Theravance Biopharma Investigational Site

München, Bavaria, Germany

Theravance Biopharma Investigational Site

Hanover, Lower Saxony, Germany

Theravance Biopharma Investigational Site

Kiel, Schleswig-Holstein, Germany

Theravance Biopharma Investigational Site

Berlin, , Germany

Theravance Biopharma Investigational Site

Hamburg, , Germany

Theravance Biopharma Investigational Site

Athens, Attica, Greece

Theravance Biopharma Investigational Site

Heraklion, Crete, Greece

Theravance Biopharma Investigational Site

Baja, Bács-Kiskun county, Hungary

Theravance Biopharma Investigational Site

Debrecen, Hajdú-Bihar, Hungary

Theravance Biopharma Investigational Site

Gyöngyös, Heves County, Hungary

Theravance Biopharma Investigational Site

Budapest, , Hungary

Theravance Biopharma Investigational Site

Be’er Ya‘aqov, Rehoboth, Israel

Theravance Biopharma Investigational Site

Rehovot, Rehoboth, Israel

Theravance Biopharma Investigational Site

Kfar Saba, Sharon, Israel

Theravance Biopharma Investigational Site

Haifa, , Israel

Theravance Biopharma Investigational Site

Holon, , Israel

Theravance Biopharma Investigational Site

Jerusalem, , Israel

Theravance Biopharma Investigational Site

Nahariya, , Israel

Theravance Biopharma Investigational Site

Petah Tikva, , Israel

Theravance Biopharma Investigational Site

Tel Aviv, , Israel

Theravance Biopharma Investigational Site

Hamilton, Waikato Region, New Zealand

Theravance Biopharma Investigational Site

Lower Hutt, Wellington Region, New Zealand

Theravance Biopharma Investigational Site

Poznan, Greater Poland Voivodeship, Poland

Theravance Biopharma Investigational Site

Włocławek, Kuyavian-Pomeranian Voivodeship, Poland

Theravance Biopharma Investigational Site

Krakow, Lesser Poland Voivodeship, Poland

Theravance Biopharma Investigational Site

Wroclaw, Lower Silesian Voivodeship, Poland

Theravance Biopharma Investigational Site

Wroclaw, Lower Silesian Voivodeship, Poland

Theravance Biopharma Investigational Site

Warsaw, Masovian Voivodeship, Poland

Theravance Biopharma Investigational Site

Warsaw, Masovian Voivodeship, Poland

Theravance Biopharma Investigational Site

Warsaw, Masovian Voivodeship, Poland

Theravance Biopharma Investigational Site

Warsaw, Masovian Voivodeship, Poland

Theravance Biopharma Investigational Site

Warsaw, Masovian Voivodeship, Poland

Theravance Biopharma Investigational Site

Rzeszów, Podkarpackie Voivodeship, Poland

Theravance Biopharma Investigational Site

Sopot, Pomeranian Voivodeship, Poland

Theravance Biopharma Investigational Site

Tychy, Silesian Voivodeship, Poland

Theravance Biopharma Investigational Site

Szczecin, Zachodnio-Pomorskie, Poland

Theravance Biopharma Investigational Site

Lodz, Łódź Voivodeship, Poland

Theravance Biopharma Investigational Site

Lodz, Łódź Voivodeship, Poland

Theravance Biopharma Investigational Site

Lodz, Łódź Voivodeship, Poland

Theravance Biopharma Investigational Site

Braga, , Portugal

Theravance Biopharma Investigational Site

Guimarães, , Portugal

Theravance Biopharma Investigational Site

Leiria, , Portugal

Theravance Biopharma Investigational Site

Lisbon, , Portugal

Theravance Biopharma Investigational Site

Santa Maria da Feira, , Portugal

Theravance Biopharma Investigational Site

Setúbal, , Portugal

Theravance Biopharma Investigational Site

Vila Nova de Gaia, , Portugal

Theravance Biopharma Investigational Site

Oradea, Bihor County, Romania

Theravance Biopharma Investigational Site

Bucharest, București, Romania

Theravance Biopharma Investigational Site

Cluj-Napoca, Cluj, Romania

Theravance Biopharma Investigational Site

Timișoara, Timiș County, Romania

Theravance Biopharma Investigational Site

Timișoara, Timiș County, Romania

Theravance Biopharma Investigational Site

Bucharest, , Romania

Theravance Biopharma Investigational Site

Cluj-Napoca, , Romania

Theravance Biopharma Investigational Site

Moscow, Moscow City, Russia

Theravance Biopharma Investigational Site

Rostov-on-Don, Rostov Oblast, Russia

Theravance Biopharma Investigational Site

Samara, Samara Oblast, Russia

Theravance Biopharma Investigational Site

Novosibirsk, , Russia

Theravance Biopharma Investigational Site

Novosibirsk, , Russia

Theravance Biopharma Investigational Site

Saint Petersburg, , Russia

Theravance Biopharma Investigational Site

Saint Petersburg, , Russia

Theravance Biopharma Investigational Site

Saratov, , Russia

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, , Serbia

Theravance Biopharma Investigational Site

Johannesburg, Gauteng, South Africa

Theravance Biopharma Investigational Site

Johannesburg, Gauteng, South Africa

Theravance Biopharma Investigational Site

Lenasia, Gauteng, South Africa

Theravance Biopharma Investigational Site

Claremont, Western Cape, South Africa

Theravance Biopharma Investigational Site

Wŏnju, Gangwon-do, South Korea

Theravance Biopharma Investigational Site

Guri-si, Gyeonggi-do, South Korea

Theravance Biopharma Investigational Site

Seongnam-si, Gyeonggi-do, South Korea

Theravance Biopharma Investigational Site

Busan, , South Korea

Theravance Biopharma Investigational Site

Daegu, , South Korea

Theravance Biopharma Investigational Site

Seoul, , South Korea

Theravance Biopharma Investigational Site

Seoul, , South Korea

Theravance Biopharma Investigational Site

Las Palmas de Gran Canaria, Las Palmas, Spain

Theravance Biopharma Investigational Site

Barcelona, , Spain

Theravance Biopharma Investigational Site

Barcelona, , Spain

Theravance Biopharma Investigational Site

Huelva, , Spain

Theravance Biopharma Investigational Site

Madrid, , Spain

Theravance Biopharma Investigational Site

Valencia, , Spain

Theravance Biopharma Investigational Site

Kiev, KIEV CITY, Ukraine

Theravance Biopharma Investigational Site

Kyiv, KIEV CITY, Ukraine

Theravance Biopharma Investigational Site

Kyiv, Kyiv City, Ukraine

Theravance Biopharma Investigational Site

Kremenchuk, Poltava Oblast, Ukraine

Theravance Biopharma Investigational Site

Uzhhorod, Transcarpathian, Ukraine

Theravance Biopharma Investigational Site

Uzhhorod, Zakarpattia Oblast, 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

Lviv, , Ukraine

Theravance Biopharma Investigational Site

Vinnytsia, , Ukraine

Theravance Biopharma Investigational Site

Zaporizhzhya, , Ukraine

Theravance Biopharma Investigational Site

Zaporizhzhya, , Ukraine

Theravance Biopharma Investigational Site

Blackpool, England, United Kingdom

Theravance Biopharma Investigational Site

London, England, United Kingdom

Theravance Biopharma Investigational Site

Glasgow, Scotland, United Kingdom

Countries

United States; Australia; Austria; Bulgaria; Croatia; France; Georgia; Germany; Greece; Hungary; Israel; New Zealand; Poland; Portugal; Romania; Russia; Serbia; South Africa; South Korea; Spain; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-001272-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0173

Identifier Type: -

Identifier Source: org_study_id