A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Who is this study for? Patients with moderately to severely active ulcerative colitis
What treatments are being studied? Efavaleukin alfa
Status: Terminated
Location: See all (195) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Participant has provided informed consent prior to initiation of any study specific activities or procedures.

• Men and women aged ≥ 18 to \< 80 years at screening visit (≥ 19 to \< 80 in South Korea).

• Diagnosis of UC established ≥ 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. If a histopathology report is not available at screening, then additional biopsies may be taken during the screening period for local histopathology analysis to corroborate.

• Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy subscore ≥ 2.

• Has documentation of:

‣ A surveillance colonoscopy (performed according to local standard) within 12 months of day 1 visit for participants with pancolitis of \> 8 years duration, or participants with left-sided colitis of \> 12 years duration, or participants with primary sclerosing cholangitis.

⁃ At the discretion of the investigator, a colonoscopy (instead of a rectosigmoidoscopy) may be performed as the screening endoscopy for this study.

⁃ For all other participants, up-to-date colorectal cancer surveillance (performed according to local standard). Participants who do not have a colonoscopy report available in source documentation will have a colonoscopy instead of rectosigmoidoscopy performed as the screening endoscopy for the study.

• Participants must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, Janus kinase \[JAK\]-inhibitor or or S1P modulators), as follows:

∙ Conventional therapy failed participants:

⁃ Corticosteroids (corticosteroid-refractory colitis, defined as signs and/or symptoms of active UC despite oral prednisone \[or equivalent\] at doses of at least 30 mg/day for a minimum of 2 weeks; or corticosteroid-dependent colitis, defined as: an inability to reduce corticosteroids below the equivalent of prednisone 10 mg/day within 3 months of starting corticosteroids without a return of signs and/or symptoms of active UC; or a relapse within 3 months of completing a course of corticosteroids).

• History of intolerance of corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/ osteoporosis, hyperglycemia, or neuropsychiatric side-effects, including insomnia, associated with corticosteroid treatment).

• Immunomodulators: signs and/or symptoms of persistently active disease despite at least 3 months treatment with one of the following at locally approved doses: oral azathioprine (eg, ≥ 1.5 mg/kg/day) or 6-mercaptopurine (eg, ≥ 0.75 mg/kg/day), or oral azathioprine or 6-mercatopurine within a therapeutic range as judged by thioguanine metabolite testing, or a combination of a thiopurine and allopurinol within a therapeutic range as judged by thioguanine metabolite testing.

• History of intolerance to at least 1 immunomodulator (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, and lymphopenia) and have neither failed nor demonstrated an intolerance to a biological medication (anti-tumor necrosis factor \[TNF\] antibody, anti-integrin antibody, or interleukin \[IL\]-12/23 antagonists) that is indicated for the treatment of UC.

‣ Biologic or targeted small molecule therapy failed participants: those who demonstrated inadequate response or loss of response or intolerance to biologic therapy for UC (eg, anti-TNF antibodies or IL-12/23 antagonists, anti-integrin antibodies) or targeted small molecules (eg, JAK inhibitors or S1P modulators). The therapy used to qualify the participant for entry into this category must be approved for the treatment of UC in the country of use, at the time of use. Participants must fulfil one of the following criteria:

⁃ Inadequate response: signs and symptoms of persistently active disease despite induction treatment at the approved induction dosing that was indicated in the product label at the time of use.

• Loss of response: recurrence of signs and symptoms of active disease during approved maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not quality as having failed or being intolerant to UC biological therapy, JAK inhibitor, or S1P modulators).

• Intolerance: history of intolerance to infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib or other approved biologicals, JAK inhibitors or S1P modulators (including but not limited to infusion-related event, demyelination, congestive heart failure, or any other drug-related adverse event that led to a reduction in dose or discontinuation of the medication).

• If receiving any of the following therapies, participants must have stable dosage for the specified duration:

‣ 5-aminosalicylates (ASAs), stable dosage for ≥ 2 weeks prior to screening endoscopy.

⁃ Oral corticosteroids: prednisone ≤ 20 mg/day or its equivalent, stable dose for ≥ 2 weeks prior to screening endoscopy.

⁃ Budesonide: extended release tablets 9 mg/day \[budensonide MMX\], stable dose for ≥ 2 weeks prior to screening endoscopy.

⁃ Beclomethasone dipropionate: gastro-resistant prolonged-release tablet 5 mg/day, stable dose for \>= 2 weeks prior to screening endoscopy.

⁃ Conventional immunomodulators: azathioprine, 6-mercaptopurine, methotrexate, stable dosage for ≥ 12 weeks prior to screening endoscopy.

Locations
United States
Alabama
Digestive Health Specialists of the Southeast
Dothan
Birmingham Digestive Health Research, LLC
Homewood
Arizona
Arizona Health Research
Mesa
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix
California
Southern California Research Center
Coronado
United Medical Doctors
Los Alamitos
Biopharma Informatic Incorporated
Los Angeles
Gastrointestinal Biosciences Clinical Trials Limited Liability Company
Los Angeles
University of California Irvine
Orange
Santa Maria Gastroenterology Medical Group
Santa Maria
Clinical Trials Management Services LLC
Thousand Oaks
Connecticut
Gastroenterology Center of Connecticut, PC
Hamden
Florida
West Central Gastroenterology
Clearwater
Homestead Associates In Research Inc
Homestead
Indian Health Service Health Research
Kissimmee
Lake Center for Clinical Research
Lady Lake
Auzmer Research
Lakeland
University of Miami Hospital and Clinic
Miami
Ocala Gastrointestinal Research, LLC
Ocala
AdventHealth Medical Group Gastroenterology and Hepatology
Orlando
Infigo Clinical Research
Sanford
Georgia
Atlanta Gastroenterology Associates
Atlanta
Columbus Regional Research Institute, LLC
Columbus
Idaho
Grand Teton Research Group
Idaho Falls
Illinois
Rush University Medical Center
Chicago
Indiana
Digestive Research Alliance of Michiana
South Bend
Kansas
University of Kansas Medical Center
Kansas City
Massachusetts
Harvard Medical School - Brigham and Womens Hospital
Boston
University of Massachusetts Memorial Medical Center
Worcester
Maryland
Mid-Atlantic GI Research, LLC
Greenbelt
Michigan
University of Michigan
Ann Arbor
Clinical Research Institute of Michigan
Troy
West Michigan Clinical Research Center
Wyoming
Missouri
Gastrointestinal Associates Research, LLC
Columbia
Bvl Clinical Research
Liberty
Mississippi
Southern Therapy and Advanced Research LLC - Jackson
Jackson
New Jersey
Sanmora Bespoke Clinical Research Solutions
East Orange
Aga Clinical Research Associates LLC
Egg Harbor
Affiliates in Gastroenterology Digestive Disease Research
Florham Park
Atlantic Digestive Health Institute
Morristown
Premier Health Research LLC
Sparta
New Mexico
University of New Mexico
Albuquerque
Nevada
Interspond - Las Vegas Medical Research
Las Vegas
New York
New York University Grossman School of Medicine and New York University Langone Hospitals
Lake Success
Ohio
Consultants for Clinical Research
Cincinnati
Digestive Specialists Inc Research, LLC
Springboro
Oklahoma
Hightower Clinical
Oklahoma City
Options Health Research, LLC
Tulsa
Pennsylvania
Guthrie Robert Packer Hospital
Sayre
South Carolina
Medical University of South Carolina
Charleston
Columbia Digestive Health Research LLC
Columbia
Tennessee
Wake Research-ClinSearch, LLC
Chattanooga
Digestive Health Research, LLC
Hermitage
Texas
Great Lakes Research Insititute El Paso Research
El Paso
Digestive Health Associates
Houston
Digestive Research of Central Texas, LLC
Waco
Digestive Health Research of North Texas LLC
Wichita Falls
Virginia
Emeritas Research Group
Lansdowne Town Center
Blue Ridge Medical Research
Lynchburg
GI Select Health Research LLC
Richmond
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond
North Richmond Health Research
Richmond
Wisconsin
Wisconsin Center for Advanced Research
Milwaukee
Other Locations
Argentina
Hospital Privado Centro Medico de Cordoba SA
Córdoba
Centro de Investigaciones Medicas Mar del Plata
Mar Del Plata
Clinica Independencia
Munro
Cer Instituto Medico
Quilmes
Fundacion Estudios Clinicos
Rosario
CardioAlem Investigaciones
San Isidro
Austria
Medizinische Universitaet Innsbruck
Innsbruck
Landeskrankenhaus Salzburg
Salzburg
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna
Belgium
Universitair Ziekenhuis Antwerpen
Edegem
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège
Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOOD
Sofia
Diagnostic-Consultative Center Convex EOOD
Sofia
Second Multiprofile Hospital for Active Treatment - Sofia EAD
Sofia
Canada
South Edmonton Gastroenterology
Edmonton
London Health Sciences Centre, University Hospital
London
TIDHI Innovation Incorporated
Toronto
Denmark
Aalborg Universitetshospital
Aalborg
Herlev Hospital
Herlev
Hvidovre Hospital
Hvidovre
Bispebjerg Hospital
København Nv
Finland
Helsinki University Central Hospital
Helsinki
France
Centre Hospitalier Universitaire Amiens Picardie
Amiens
Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
Montpellier
Centres Medicaux Chirurgicaux Ambroise Pare Hartmann
Neuilly-sur-seine
Centre Hospitalier Universitaire Archet 2
Nice
Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord
Saint-priest-en-jarez
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
Vandœuvre-lès-nancy
Germany
Gastro-Studien GbR Studienzentrum
Berlin
Universitaetsklinikum Essen
Essen
Universitaetsklinikum Frankfurt
Frankfurt Am Main
Universitaetsklinikum Schleswig-Holstein
Kiel
Universitaetsklinikum Tuebingen
Tübingen
Universitaetsklinikum Ulm
Ulm
Greece
University General Hospital of Alexandroupolis
Alexandroupoli
General Hospital Evangelismos
Athens
Laiko General Hospital of Athens
Athens
University Hospital Attikon
Haidari
University Hospital of Heraklion
Heraklion
Venizeleio General Hospital
Heraklion
University General Hospital of Ioannina
Ioannina
General University Hospital of Patras Panagia i Voithia
Pátrai
Hungary
Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz
Békéscsaba
Clinexpert Kft
Budapest
MIND Klinika Kft
Budapest
Obudai Egeszsegugyi Centrum Kft
Budapest
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged
Clinfan Kft
Szekszárd
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro
Azienda Ospedaliero Universitaria Careggi
Florence
Ospedale Policlinico San Martino IRCCS
Genoa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
IRCCS Ospedale San Raffaele
Milan
Ospedale Sacro Cuore Don Calabria
Negrar Vr
Ospedale Sandro Pertini
Roma
Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku
Gifu University Hospital
Gifu
Hakodate Central General Hospital
Hakodate-shi
Matsunami General Hospital
Hashima-gun
Gokeikai Ofuna Chuo Hospital
Kamakura-shi
Nara Medical University Hospital
Kashihara-shi
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi
Kitakyushu Municipal Medical Center
Kitakyushu-shi
Aoyama Clinic GI Endoscopy and IBD Center
Kobe
Yamanashi Prefectural Central Hospital
Kofu
Kitasato University Kitasato Institute Hospital
Minato-ku
Kyorin University Hospital
Mitaka-shi
Miyazaki Prefectural Miyazaki Hospital
Miyazaki
Nagasaki University Hospital
Nagasaki
National Hospital Organization Okayama Medical Center
Okayama
Ome Medical Center
Ome-shi
Osaka Metropolitan University Hospital
Osaka
Toho University Sakura Medical Center
Sakura-shi
Sapporo Tokushukai Hospital
Sapporo
Takagi Clinic
Sendai
Medical Corporation ENEXT Ikebukuro West Gate Hospital
Toshima-ku
Latvia
Gastro Centrs
Riga
Pauls Stradins Clinical University Hospital
Riga
Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC
Culiacán
Clinica de Investigacion en Reumatologia y Obesidad SC
Guadalajra
Clinicos Asociados BOCM SC
Mexico City
CRI Centro Regiomontano de Investigacion SC
Monterrey
Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBP
Monterrey
Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
Zapopan
Netherlands
Leids Universitair Medisch Centrum
Leiden
Elisabeth TweeSteden Ziekenhuis
Tilburg
Universitair Medisch Centrum Utrecht
Utrecht
Poland
NZOZ Twoje Zdrowie EL Spzoo
Elblag
Centrum Medyczne Med-Gastr Sp zoo
Lodz
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
Malbork
Oleg Tyszkiwski Centrum Gastrologiczne Gorczyn Oleg Tyszkiwski
Poznan
Centrum Medyczne Pratia Poznan
Skorzewo
BodyClinic spolka z ograniczona odpowiedzialnoscia
Warsaw
EuroMediCare Przychodnia Specjalistyczna we Wroclawiu
Wroclaw
Centrum Medyczne Melita Medical
Wroclaw-krzyki
Republic of Korea
Inje University Haeundae Paik Hospital
Busan
Yeungnam University Medical Center
Daegu
Samsung Medical Center
Seoul
The Catholic University of Korea Seoul St Marys Hospital
Seoul
Wonju Severance Christian Hospital
Wonju-si, Gangwon-do
Romania
Clinica Medicum
Bucharest
Institutul Clinic Fundeni
Bucharest
Memorial Healthcare International SRL
Bucharest
Spitalul Clinic Colentina
Bucharest
Spitalul Universitar de Urgenta Militar Central Dr Carol Davila
Bucharest
Spitalul Clinic Pelican
Oradea
Slovakia
Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica
Banská Bystrica
Endomed, sro
Košice
Gastro I, sro
Prešov
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario de La Princesa
Madrid
Hospital Universitario La Paz
Madrid
Switzerland
Inselspital Bern
Bern
Intesto BE
Bern
Kantonsspital St Gallen
Sankt Gallen
Universitaetsspital Zuerich
Zurich
Taiwan
China Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Turkey
Ankara Bilkent Sehir Hastanesi
Ankara
Antalya Egitim ve Arastirma Hastanesi
Antalya
Uludag Universitesi Tip Fakultesi Hastanesi
Bursa
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
Izmir
Ege Universitesi Tip Fakultesi Hastanesi
Izmir
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin
Time Frame
Start Date: 2022-01-31
Completion Date: 2024-10-22
Participants
Target number of participants: 224
Treatments
Experimental: Arm A: Efavaleukin alfa
Efavaleukin alfa Dose 1 administered by SC injection once every two weeks (Q2W)
Experimental: Arm B: Efavaleukin alfa
Efavaleukin alfa Dose 2 administered by SC injection Q2W
Experimental: Arm C: Efavaleukin alfa
Efavaleukin alfa Dose 3 administered by SC injection Q2W
Placebo_comparator: Arm D: Placebo
Placebo Q2W
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov

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