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A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02819635
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical remission in order to identify the induction dose of ABT-494 for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of ABT-494 compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of ABT-494 compared to placebo in achieving clinical remission in participants who had a response following induction with ABT-494.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Drug: Placebo Drug: ABT-494 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1055 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : September 28, 2016
Estimated Primary Completion Date : April 27, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABT-494 Dose B
Administered orally, once daily.
Drug: ABT-494
Tablet
Other Name: Upadacitinib

Experimental: ABT-494 Dose A
Administered orally, once daily.
Drug: ABT-494
Tablet
Other Name: Upadacitinib

Experimental: ABT-494 Dose C
Administered orally, once daily.
Drug: ABT-494
Tablet
Other Name: Upadacitinib

Experimental: ABT-494 Dose D
Administered orally, once daily.
Drug: ABT-494
Tablet
Other Name: Upadacitinib

Placebo Comparator: Placebo
Administered orally, once daily.
Drug: Placebo
Tablet




Primary Outcome Measures :
  1. Substudy 1/Substudy 2: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical remission is defined as stool frequency subscore (SFS) <= 1, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.

  2. Substudy 3: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 44 ]
    Clinical remission is defined as stool frequency subscore (SFS) <= 1, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.


Secondary Outcome Measures :
  1. Substudy 3: Proportion of participants who discontinued corticosteroid use that achieved clinical remission per Adapted Mayo score at Week 44 [ Time Frame: At Week 44 ]
    Participants who discontinued corticosteroid use and achieved clinical remission per Adapted Mayo score, defined as Stool Frequency Subscore (SFS) <= 1, Rectal Bleeding Subscore (RBS) of 0, and endoscopic subscore <= 1.

  2. Substudy 1/Substudy 2: Proportion of participants achieving clinical response per Adapted Mayo score at Week 8 [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo is defined as a decrease from baseline in the Adapted Mayo score >= 2 points and >= 30% from baseline, PLUS a decrease in rectal bleeding subscore (RBS) >= 1 or an absolute RBS <= 1.

  3. Substudy 3: Proportion of participants achieving clinical remission per Full Mayo score at Week 44 [ Time Frame: At Week 44 ]
    Clinical remission per Full Mayo score is defined as a Full Mayo score <= 2 with no subscore > 1

  4. Substudy 1/Substudy 2: Proportion of participants achieving clinical remission per Full Mayo score at Week 8 [ Time Frame: At Week 8 ]
    Clinical remission is defined as a Full Mayo score <= 2 with no subscore > 1

  5. Substudy 3: Proportion of participants with endoscopic improvement at Week 44 [ Time Frame: At Week 44 ]
    Endoscopic improvement is defined as an endoscopic subscore <= 1

  6. Substudy 1/Substudy 2: Proportion of participants with endoscopic improvement at Week 8 [ Time Frame: At Week 8 ]
    Endoscopic improvement is defined as an endoscopic subscore <= 1



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
  • Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
  • Demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunosuppressants, and/or biologic therapies.
  • If female, participant must meet the criteria for Contraception Recommendations and Pregnancy Testing.
  • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.
  • Male participants must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 90 days post last dose of study drug.

Exclusion Criteria:

  • Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
  • Current diagnosis of fulminant colitis and/or toxic megacolon.
  • Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
  • Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline.
  • Participant on azathioprine or 6-mercaptopurine within 10 days of baseline.
  • Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
  • Participant with previous exposure to JAK inhibitor (e.g., tofacitinib, baricitinib, filgotinib).
  • Screening laboratory and other analyses show any abnormal results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819635


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Szombathely, Vas, Hungary, 9700
Bekes Megyei Kozponti Korhaz Not yet recruiting
Bekescsaba, Hungary, 5600
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1085
Meditres Kft. Not yet recruiting
Kecskemet, Hungary, 6000
Soproni Erzsebet Oktato Korhaz Not yet recruiting
Sopron, Hungary, 9400
Ireland
Mercy University Hospital Recruiting
Cork, Ireland, T12 WE28
Trinity College Dublin - St. J Recruiting
Dublin, Ireland, 8580
St Vincent's University Hosp Recruiting
Dublin, Ireland, D04 T6F4
Beaumont Hospital Recruiting
Dublin, Ireland, D09 XR63
Galway University Hospital Not yet recruiting
Galway, Ireland, H91 YR71
Israel
Soroka Medical Center Recruiting
Be'er Sheva, Israel, 85025
Rambam Health Care Campus Active, not recruiting
Haifa, Israel, 3109601
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Hadassah Ein Kerem Medical Ctr Recruiting
Jerusalem, Israel, 91120
Italy
A.O.U. Policlinico S.Orsola-Malpighi Recruiting
Bologna, Emilia-Romagna, Italy, 40138
A.O. San Camillo Forlanini Not yet recruiting
Rome, Lazio, Italy, 00152
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milan, Lombardia, Italy, 20122
Istituto Clinico Humanitas Not yet recruiting
Rozzano, Milano, Italy, 20089
A.O. Ospedali Riuniti Villa Sofia - Cervello Recruiting
Palermo, Sicilia, Italy, 90146
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico Recruiting
Milano, Italy, 20121
Policlinico Tor Vergata Not yet recruiting
Rome, Italy, 00133
Complesso integrato Columbus Recruiting
Rome, Italy, 00168
Japan
Aichi Medical University Hosp Recruiting
Nagakute, Aichi, Japan, 4801195
Nagoya University Hospital Recruiting
Nagoya-shi, Aichi, Japan, 466-8560
Nagoya City University Hospital Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Hirosaki National Hospital Recruiting
Hirosaki-shi, Aomori, Japan, 036-8545
Toho University Sakura Med Ctr Recruiting
Sakura-shi, Chiba, Japan, 285-8741
Fukuoka Univ Chikushi Hosp Not yet recruiting
Chikushino, Fukuoka, Japan, 818-8502
Kyushu University Hospital Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital Recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Hokkaido Sapporo-Kosei Gen Hos Recruiting
Sapporo, Hokkaido, Japan, 060-0033
Aoyama Clinic Recruiting
Kobe, Hyogo, Japan, 650-0015
The Hospital of Hyogo College of Medicine Recruiting
Nishinomiya, Hyogo, Japan, 663-8501
National Hospital Organization Mito Medical Center Not yet recruiting
Higashi Ibaraki-gun, Ibaraki, Japan, 3113193
Yokohama City Univ Med Center Not yet recruiting
Yokohama-shi, Kanagawa, Japan, 232-0024
JP Red Cross Kyoto Daiichi Hos Recruiting
Kyoto-shi, Kyoto, Japan, 605-0981
Osaka City University Hospital Recruiting
Osaka-shi, Osaka, Japan, 〒545-0051
Saitama Medical Center Not yet recruiting
Kawagoe-shi, Saitama, Japan, 350-8550
Tokito Clinic Recruiting
Saitama-shi, Saitama, Japan, 336-0963
Medical Hospital of Tokyo Medical and Dental University Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
Tokai University Hachioji Hosp Recruiting
Hachioji, Tokyo, Japan, 〒192-0032
Kitasato Univ Kitasato Inst Ho Recruiting
Minato-ku, Tokyo, Japan, 108-8642
Kyorin University Hospital Recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Yamanashi Prefectural Ctr Hosp Recruiting
Kofu-shi, Yamanashi, Japan, 400-8506
Asahikawa Medical Univ Hosp Not yet recruiting
Asahikawa-shi, Japan, 078-8510
Hiroshima Prefectural Hospital Not yet recruiting
Hiroshima, Japan, 734-8530
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
Kitakyushu Municipal Med Ctr Not yet recruiting
Kitakyushu, Japan, 802-0077
Chikuba Hospital Recruiting
Kurashiki, Japan, 710-0142
NHO Shizuoka Medical Center Not yet recruiting
Shimizu-sho, Japan
Toyohashi Municipal Hospital Not yet recruiting
Toyohashi, Japan, 441-8570
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp Not yet recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Yeungnam University Med Ctr Recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
CHA Bundang Medical center, CHA University Not yet recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
St. Vincent's Hospital Recruiting
Suwon, Gyeonggido, Korea, Republic of, 16247
Samsung Medical Center Recruiting
Gangnam-gu, Seoul Teugbyeolsi, Korea, Republic of, 06351
Kangbuk Samsung Hospital Recruiting
Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
Severance Hospital Not yet recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
Hanyang University Guri Hosp Not yet recruiting
Guri-si, Korea, Republic of, 471-701
Latvia
Riga East Clinical Univ Hosp Not yet recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp Recruiting
Riga, Latvia, LV-1002
Lithuania
Klaipeda University Hospital Not yet recruiting
Klaipeda, Lithuania, 92288
Malaysia
Hospital Sultanah Bahiyah Recruiting
Alor Setar, Kedah, Malaysia, 05460
UKM Medical Centre Not yet recruiting
Kuala Lumpur, Selangor, Malaysia, 56000
Hospital Ampang Recruiting
Ampang, Selangor, Malaysia, 68000
Uni Malaya MC Recruiting
Kuala Lumpur, Malaysia, 59100
Mexico
CIRO - CLIN de Reum y Obesidad Not yet recruiting
Guadalajara Jalisco, Mexico, CP 44650
ISSSTE Not yet recruiting
Guadalajara, Jalisco, Mexico, 44600
Centro Regiomontano de Estudio Not yet recruiting
Monterrey, Mexico, 64610
Netherlands
Univ Med Ctr, St. Radboud Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Academisch Medisch Centrum Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Leids Universitair Medisch Cen Recruiting
Leiden, Netherlands, 2333 ZA
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, 3015 CE
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Norway
Akershus universitetssykehus Recruiting
Nordbyhagen, Akershus, Norway, 1474
Universitetssykehuset Nord-Norge Recruiting
Tromsø, Troms, Norway, 9019
Poland
Zespol Przychodni Prima Recruiting
Warsaw, Mazowieckie, Poland, 02-018
Centrum Zdrowia Matki, Dziecka i Mlodziezy Recruiting
Warszawa, Mazowieckie, Poland, 01-783
Endoterapia PFG Sp. z.o.o. Recruiting
Warszawa, Mazowieckie, Poland, 02-653
Endoskopia Sp. z o.o. Recruiting
Sopot, Zachodniopomorskie, Poland, 81-756
Portugal
Hospital Senhora da Oliveira de Guimarães, EPE Not yet recruiting
Guimarães, Braga, Portugal, 4835-044
Hospital Garcia de Orta, E.P.E Recruiting
Almada, Lisboa, Portugal, 2805-267
Centro Hosp de Lisboa Central Not yet recruiting
Lisbon, Lisboa, Portugal, 1169-050
CCA Braga - Hospital de Braga Not yet recruiting
Braga, Portugal, 4710-243
Centro Hospitalar Lisboa Norte, EPE Not yet recruiting
Lisboa, Portugal, 1649-035
Centro Hospitalar de Sao Joao, EPE Recruiting
Porto, Portugal, 4200-319
Centro Hospitalar de Entre o D Not yet recruiting
Santa Maria Da Feira, Portugal, 4520-211
Unidade Local De Saude Do Alto Minho Recruiting
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
University of Puerto Rico, School of Medicine Recruiting
San Juan, Puerto Rico, 00935
Romania
Clinic Fundeni Institute Not yet recruiting
Bucuresti, Romania, 030463
Cabinet Particular Algomed SRL Not yet recruiting
Timisoara, Romania, 300002
Russian Federation
Immanuel Kant Baltic Federal University Not yet recruiting
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
LLC Meditsinskiy Dom Not yet recruiting
Moscow, Moskovskaya Oblast, Russian Federation, 109451
Perm Clinical Center of FMBA Recruiting
Perm, Permskiy Kray, Russian Federation, 614105
LLC Medical Company Hepatolog Not yet recruiting
Samara, Samarskaya Oblast, Russian Federation, 443063
LLC Uromed Not yet recruiting
Smolensk, Smolenskaya Oblast, Russian Federation, 214031
Kazan State Medical University Not yet recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420012
City Clinical Hospital 24 Not yet recruiting
Moscow, Russian Federation, 127015
Stavropol State Medical Univ Recruiting
Stavropol, Russian Federation, 355017
Serbia
Clinical Center Serbia Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Military Medical Academy Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara Not yet recruiting
Belgrade, Beograd, Serbia, 11050
Clin Hosp Ctr Bezanijska Kosa Not yet recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center of Nis Not yet recruiting
NIS, Nisavski Okrug, Serbia, 18000
Clinical Center Kragujevac Not yet recruiting
Kragujevac, Sumadijski Okrug, Serbia, 34000
Clinical Center Vojvodina Not yet recruiting
Novi Sad, Vojvodina, Serbia, 21000
Singapore
National University Hospital Not yet recruiting
Singapore, Singapore, 119074
Singapore General Hospital Not yet recruiting
Singapore, Singapore, 169608
Slovakia
Medak s.r.o., gastroenterologi Not yet recruiting
Bratislava, Bratislavsky Kraj, Slovakia, 851 01
FN s poliklinikou F.D. Rooseve Recruiting
Banska Bystrica, Slovakia, 97517
Slovak Research Center Team Me Not yet recruiting
Ilava, Slovakia, 019 01
B and B MED s.r.o. Not yet recruiting
Kosice, Slovakia, 040 01
Gastro I.S.R.O. Recruiting
Presov, Slovakia, 08001
South Africa
Clinresco Centres Recruiting
Johannesburg, Gauteng, South Africa, 1619
Chris Hani Baragwanath Hosp Recruiting
Johannesburg, Gauteng, South Africa, 1864
Wits Clinical Research Site Not yet recruiting
Johannesburg, Gauteng, South Africa, 2193
Mediclinic Milnerton Not yet recruiting
Cape Town, Western Cape, South Africa, 7441
Kingsbury Hospital Recruiting
Cape Town, Western Cape, South Africa, 7708
Mediclinic Constantiaberg Not yet recruiting
Cape Town, Western Cape, South Africa, 7800
MD Search Not yet recruiting
Boksburg North, South Africa, 1460
Spain
Comple Hospi Univ de Santiago Not yet recruiting
Santiago de Compostela, A Coruna, Spain, 15706
Hospital Universitario y Politecnico La Fe Recruiting
Valencia, Valenciana, Spain, 46026
Hospital Clinic de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Hospital Reina Sofia de Cordob Not yet recruiting
Cordoba, Spain, 14004
Hospital Univ Ramon y Cajal Not yet recruiting
Madrid, Spain, 28034
Complejo Asistencial de Salama Not yet recruiting
Salamanca, Spain, 37007
Sweden
Sahlgrenska University Hosp Not yet recruiting
Goteborg, Sweden, 413 45
Switzerland
Kantonsspital St. Gallen Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Universitaetsspital Basel Recruiting
Basel, Switzerland, 4056
Inselspital, Universitaetsklin Recruiting
Bern, Switzerland, 3010
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Taiwan
China Medical University Hosp Recruiting
Taichung City, Taichung, Taiwan, 40447
National Cheng Kung University Hospital Not yet recruiting
Tainan City, Tainan, Taiwan, 70403
National Taiwan University Hospital Recruiting
Taipei City, Taipei, Taiwan, 100
Kaohsiung Medical University Not yet recruiting
Kaohsiung, Taiwan, 80708
Chung Shan Medical University Not yet recruiting
Taichung City, Taiwan, 40201
Taipei Veterans General Hosp Recruiting
Taipei City, Taiwan, 11217
Turkey
Erciyes University Medical Fac Not yet recruiting
Melikgazi, Kayseri, Turkey, 38030
Gazi Universitesi Tip Fakultes Not yet recruiting
Ankara, Turkey, 06500
Istanbul University Cerrahpasa Not yet recruiting
Istanbul, Turkey, 34098
Umraniye Training and Res Hosp Not yet recruiting
Istanbul, Turkey, 34764
Mersin University Medical Not yet recruiting
Mersin, Turkey, 33343
Ukraine
Kyiv Municipal Clinical Hospital #18 Not yet recruiting
Kiev, Kyiv, Ukraine, 1030
Medical Center of the "Health Not yet recruiting
Вінниця, Vinnytska Oblast, Ukraine, 21009
Lviv Regional Clinical Hospita Recruiting
Lviv, Ukraine, 79010
Odessa Regional Clinical Hosp Not yet recruiting
Odesa, Ukraine, 65025
United Kingdom
RD&E Hospital Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Queen Elizabeth University Hos Recruiting
Glasgow, Glasgow City, United Kingdom, G51 4TF
Basingstoke & North Hampshire Recruiting
Basingstoke, United Kingdom, RG24 9NA
Royal United Hospitals Bath Recruiting
Bath, United Kingdom, BA1 3NG
Univ Hospitals Birmingham NHS Foundation trust Not yet recruiting
Birmingham, United Kingdom, B15 2TG
The Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02819635     History of Changes
Other Study ID Numbers: M14-234
2016-000641-31 ( EudraCT Number )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
ABT-494
Moderately to Severely Active UC

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases