Efficacy & Safety of TD-1473 in Ulcerative Colitis

NCT ID: NCT03758443

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2021-10-20

Brief Summary

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

Detailed Description

This protocol consists of 3 separate studies: an 8-week Phase 2b dose-finding induction study, an 8-week dose-confirming Phase 3 induction study, and a 44-week Phase 3 maintenance study. Subjects who respond to induction will enter the maintenance study; those who do not will receive TD-1473 during extended induction. The safety and efficacy data of the Phase 2b study will be analyzed to select the induction and maintenance dose regimens for the confirmatory Phase 3 studies. Participants who have disease relapse or complete the maintenance study may be eligible to enter a separate long-term safety study. Efficacy, pharmacokinetic, biomarkers, and safety will be evaluated in all 3 studies.

240 subjects are planned for the Phase 2b and the planned Primary Completion Date for this portion of the study is JULY 2021. 640 subjects are planned for the Phase 3 portion of the study.

Conditions

Ulcerative Colitis (UC)

Study Design

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

Study Groups

Active Treatment TD-1473 Dose A

Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.

Group Type: EXPERIMENTAL

TD-1473 Dose A

Intervention Type: DRUG

See Arm description

Active Treatment TD-1473 Dose B

Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.

Group Type: EXPERIMENTAL

TD-1473 Dose B

Intervention Type: DRUG

See Arm description

Active Treatment TD-1473 Dose C

Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.

Group Type: EXPERIMENTAL

TD-1473 Dose C

Intervention Type: DRUG

See Arm description

Placebo

Participants will be randomized to receive an oral daily dose of placebo. Participants who received Placebo (and were non-responders) may move to an extended induction. Subjects who are on placebo will be assigned to active TD-1473 for the extended induction (they will be blinded to dose).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

See Arm description

Interventions

TD-1473 Dose A

See Arm description

Intervention Type: DRUG

TD-1473 Dose B

See Arm description

Intervention Type: DRUG

TD-1473 Dose C

See Arm description

Intervention Type: DRUG

Placebo

See Arm description

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Is at least 18 years of age at screening
• Has a history of UC for at least 3 months prior to screening
• Has moderately-to-severely active UC, as defined by a Mayo endoscopic subscore of ≥2 points and an adapted Mayo score between 4 - 9 points inclusive
• Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids, immunomodulators) or biologics
• Willing to use highly-effective methods of contraception during the study and for 7 days after the last dose

Exclusion Criteria

• Has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation
• Likely to require surgery for UC or other major surgeries
• Has previously received / is currently receiving prohibited medications within specified timeframe
• Is refractory to 3 biologics with ≥2 mechanisms of action
• Has a current bacterial, parasitic, fungal, or viral infection
• Has clinically significant abnormalities in laboratory evaluations
• Has had any prior exposure to an approved Janus kinase (JAK) inhibitor or potential exposure to an investigational JAK inhibitor that was stopped due to intolerance or lack of efficacy

• 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

Chula Vista, California, United States

Theravance Biopharma Investigational Site

La Jolla, California, United States

Theravance Biopharma Investigational Site

Lancaster, California, United States

Theravance Biopharma Investigational Site

Orange, California, United States

Theravance Biopharma Investigational Site

Colorado Springs, Colorado, United States

Theravance Biopharma Investigational Site

Aventura, Florida, United States

Theravance Biopharma Investigational Site

Clearwater, Florida, United States

Theravance Biopharma Investigational Site

Largo, Florida, United States

Theravance Biopharma Investigational Site

Miami, 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

New Smyrna Beach, Florida, United States

Theravance Biopharma Investigational Site

Orlando, Florida, United States

Theravance Biopharma Investigational Site

Pembroke Pines, Florida, United States

Theravance Biopharma Investigational Site

Atlanta, Georgia, United States

Theravance Biopharma Investigational Site

Suwanee, Georgia, United States

Theravance Biopharma Investigational Site

Idaho Falls, Idaho, United States

Theravance Biopharma Investigational Site

Kansas City, Kansas, United States

Theravance Biopharma Investigational Site

Louisville, Kentucky, United States

Theravance Biopharma Investigational Site

Monroe, Louisiana, United States

Theravance Biopharma Investigational Site

Baltimore, Maryland, United States

Theravance Biopharma Investigational Site

Troy, Michigan, United States

Theravance Biopharma Investigational Site

Wyoming, Michigan, United States

Theravance Biopharma Investigational Site

Rochester, Minnesota, United States

Theravance Biopharma Investigational Site

Kansas City, Missouri, United States

Theravance Biopharma Investigational Site

Las Vegas, Nevada, United States

Theravance Biopharma Investigational Site

New York, New York, United States

Theravance Biopharma Investigational Site

Charlotte, North Carolina, United States

Theravance Biopharma Investigational Site

Gastonia, North Carolina, United States

Theravance Biopharma Investigational Site

Greenville, North Carolina, United States

Theravance Biopharma Investigational Site

Pittsburgh, Pennsylvania, United States

Theravance Biopharma Investigational Site

Smithfield, Pennsylvania, United States

Theravance Biopharma Investigational Site

Greenville, South Carolina, United States

Theravance Biopharma Investigational Site

Rock Hill, South Carolina, United States

Theravance Biopharma Investigational Site

Nashville, Tennessee, United States

Theravance Biopharma Investigational Site

Garland, Texas, United States

Theravance Biopharma Investigational Site

Houston, Texas, United States

Theravance Biopharma Investigational Site

San Antonio, Texas, United States

Theravance Biopharma Investigational Site

South Brisbane, Queensland, Australia

Theravance Biopharma Investigational Site

Woolloongabba, Queensland, Australia

Theravance Biopharma Investigational Site

Malvern, Victoria, Australia

Theravance Biopharma Investigational Site

Murdoch, Western Australia, Australia

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 (2)

Pleven, , Bulgaria

Theravance Biopharma Investigational Site

Pleven, , Bulgaria

Theravance Biopharma Investigational Site

Plovdiv, , Bulgaria

Theravance Biopharma Investigational Site

Plovdiv, , Bulgaria

Theravance Biopharma Investigational Site

Rousse, , Bulgaria

Theravance Biopharma Investigational Site

Sliven, , Bulgaria

Theravance Biopharma Investigational Site

Sofia, , 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

Kingston, Ontario, Canada

Theravance Biopharma Investigational Site

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Theravance Biopharma Investigational Site

Saint-Etienne, Auvergne-Rhône-Alpes, France

Theravance Biopharma Investigational Site

Reims, Champagne-ardenne, France

Theravance Biopharma Investigational Site

Lille, Hauts-de-France, France

Theravance Biopharma Investigational Site

Montpellier, Languedoc-roussillon, France

Theravance Biopharma Investigational Site

Vandœuvre-lès-Nancy, Limousin, France

Theravance Biopharma Investigational Site

Toulouse, Midi-pyrenees, France

Theravance Biopharma Investigational Site

Nantes, Pays de la Loire Region, France

Theravance Biopharma Investigational Site

Amiens, Picardie, France

Theravance Biopharma Investigational Site

Batumi, , Georgia

Theravance Biopharma Investigational Site

Tbilisi, , Georgia

Theravance Biopharma Investigational Site

Tbilisi, , Georgia

Theravance Biopharma Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

Theravance Biopharma Investigational Site

Ulm, Baden-Wurttemberg, Germany

Theravance Biopharma Investigational Site

Kiel, Schleswig-Holstein, Germany

Theravance Biopharma Investigational Site

Jena, Thuringia, Germany

Theravance Biopharma Investigational Site

Berlin, , Germany

Theravance Biopharma Investigational Site

Berlin, , Germany

Theravance Biopharma Investigational Site

Athens, Attica, Greece

Theravance Biopharma Investigational Site #2

Athens, Attica, Greece

Theravance Biopharma Investigational Site

Heraklion, Crete, Greece

Theravance Biopharma Investigational Site

Patra, Peloponnese, Greece

Theravance Biopharma Investigational Site

Székesfehérvár, Fejér, Hungary

Theravance Biopharma Investigational Site

Debrecen, Hajdú-Bihar, Hungary

Theravance Biopharma Investigational Site

Szekszárd, Tolna County, Hungary

Theravance Biopharma Investigational Site

Budapest, , Hungary

Theravance Biopharma Investigational Site

Budapest, , Hungary

Theravance Biopharma Investigational Site

Ẕerifin, Rehoboth, 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

Rehovot, , Israel

Theravance Biopharma Investigational Site

Rozzano, Milano, Italy

Theravance Biopharma Investigational Site

Catanzaro, , Italy

Theravance Biopharma Investigational Site

Pavia, , Italy

Theravance Biopharma Investigational Site

Nagoya, Aichi-ken, Japan

Theravance Biopharma Investigational Site

Abiko, Chiba, Japan

Theravance Biopharma Investigational Site

Sakura, Chiba, Japan

Theravance Biopharma Investigational Site

Kurume, Fukuoka, Japan

Theravance Biopharma Investigational Site

Ōgaki, Gifu, Japan

Theravance Biopharma Investigational Site

Isesaki, Gunma, Japan

Theravance Biopharma Investigational Site

Fukuyama-Shi, Hiroshima, Japan

Theravance Biopharma Investigational Site

Hatsukaichi, Hiroshima, Japan

Theravance Biopharma Investigational Site

Kawasaki, Kanagawa, Japan

Theravance Biopharma Investigational Site

Sendai, Miyagi, Japan

Theravance Biopharma Investigational Site

Suwa, Nagano, Japan

Theravance Biopharma Investigational Site

Ōita, Oita Prefecture, Japan

Theravance Biopharma Investigational Site

Fujiidera, Osaka, Japan

Theravance Biopharma Investigational Site

Izumiōtsu, Osaka, Japan

Theravance Biopharma Investigational Site

Ageo, Saitama, Japan

Theravance Biopharma Investigational Site

Tokorozawa, Saitama, Japan

Theravance Biopharma Investigational Site

Kurobe-shi, Toyama, Japan

Theravance Biopharma Investigational Site

Chiba, , Japan

Theravance Biopharma Investigational Site

Fukuoka, , Japan

Theravance Biopharma Investigational Site

Kumamoto, , Japan

Theravance Biopharma Investigational Site

Tokyo, , Japan

Theravance Biopharma Investigational Site

Tokyo, , Japan

Theravance Biopharma Investigational Site

Tokyo, , Japan

Theravance Biopharma Investigational Site

Poznan, Greater Poland Voivodeship, Poland

Theravance Biopharma Investigational Site

Poznan, Greater Poland Voivodeship, Poland

Theravance Biopharma Investigational Site

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Theravance Biopharma Investigational Site

Włocławek, Kuyavian-Pomeranian Voivodeship, Poland

Theravance Biopharma Investigational Site

Krakow, Lesser Poland Voivodeship, Poland

Theravance Biopharma Investigational Site

Lodz, Lodzki, Poland

Theravance Biopharma Investigational Site

Wroclaw, Lower Silesian Voivodeship, Poland

Theravance Biopharma Investigational Site

Wroclaw, Lower Silesian Voivodeship, Poland

Theravance Biopharma Investigational Site

Piaseczno, 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

Sopot, Pomeranian Voivodeship, Poland

Theravance Biopharma Investigational Site

Tychy, Silesian Voivodeship, Poland

Theravance Biopharma Investigational Site

Szczecin, West Pomeranian Voivodeship, Poland

Theravance Biopharma Investigational Site

Szczecin, , Poland

Theravance Biopharma Investigational Site

Ksawerów, Łódź Voivodeship, Poland

Theravance Biopharma Investigational Site

Lodz, Łódź Voivodeship, Poland

Theravance Biopharma Investigational Site

Staszów, Świętokrzyskie Voivodeship, Poland

Theravance Biopharma Investigational Site

Coimbra, , 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

Senhora da Hora, , Portugal

Theravance Biopharma Investigational Site

Viana do Castelo, , Portugal

Theravance Biopharma Investigational Site

Vila Nova de Gaia, , Portugal

Theravance Biopharma Investigational Site

Timișoara, Timiș County, Romania

Theravance Biopharma Investigational Site

Bucharest, , Romania

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

Prešov, Prešovsky, Slovakia

Theravance Biopharma Investigational Site

Nitra, , Slovakia

Theravance Biopharma Investigational Site

Šahy, , Slovakia

Theravance Biopharma Investigational Site

Johannesburg, Gauteng, South Africa

Theravance Biopharma Investigational Site

Wŏnju, Gangwon-do, South Korea

Theravance Biopharma Investigational Site

Suwon, Gyeonggi-do, 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

Seoul, , South Korea

Theravance Biopharma Investigational Site

Seoul, , South Korea

Theravance Biopharma Investigational Site

Barcelona, , Spain

Theravance Biopharma Investigational Site

Madrid, , Spain

Theravance Biopharma Investigational Site

Seville, , Spain

Theravance Biopharma Investigational Site

Valencia, , Spain

Theravance Biopharma Investigational Site

Kaohsiung City, , Taiwan

Theravance Biopharma Investigational Site

Taichung, , Taiwan

Theravance Biopharma Investigational Site

Tainan City, , Taiwan

Theravance Biopharma Investigational Site

Taipei, , Taiwan

Theravance Biopharma Investigational Site

Kiev, KIEV CITY, Ukraine

Theravance Biopharma Investigational Site

Kyiv, Kyiv 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

Vinnytsia, Vinnytsya, Ukraine

Theravance Biopharma Investigational Site

Vinnytsia, Vinnytsya, Ukraine

Theravance Biopharma Investigational Site

Chernivtsi, , Ukraine

Theravance Biopharma Investigational Site

Kharkiv, , Ukraine

Theravance Biopharma Investigational Site #2

Lviv, , Ukraine

Theravance Biopharma Investigational Site

Lviv, , Ukraine

Theravance Biopharma Investigational Site

Ternopil, , Ukraine

Theravance Biopharma Investigational Site

Uzhhorod, , Ukraine

Theravance Biopharma Investigational Site

Vinnytsia, , Ukraine

Theravance Biopharma Investigational Site

Vinnytsia, , Ukraine

Theravance Biopharma Investigational Site

Zaporizhzhya, , Ukraine

Theravance Biopharma Investigational Site

Zaporizhzhya, , Ukraine

Countries

United States; Australia; Bulgaria; Canada; France; Georgia; Germany; Greece; Hungary; Israel; Italy; Japan; Poland; Portugal; Romania; Serbia; Slovakia; South Africa; South Korea; Spain; Taiwan; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-002136-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0157

Identifier Type: -

Identifier Source: org_study_id