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History of Changes for Study: NCT03006068
A Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects With Ulcerative Colitis (UC)
Latest version (submitted January 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 27, 2016 None (earliest Version on record)
2 March 7, 2017 Study Status and Contacts/Locations
3 April 4, 2017 Contacts/Locations, Study Status and Oversight
4 May 1, 2017 Contacts/Locations, Study Status, Oversight and Arms and Interventions
5 September 6, 2017 Contacts/Locations and Study Status
6 October 12, 2017 Contacts/Locations and Study Status
7 February 6, 2018 Contacts/Locations, Study Status, IPDSharing and Oversight
8 April 9, 2018 Contacts/Locations and Study Status
9 July 27, 2018 Contacts/Locations, IPDSharing, Arms and Interventions, Study Status, Study Identification, Eligibility, Outcome Measures, Conditions and Study Description
10 November 20, 2018 Contacts/Locations, Arms and Interventions, Study Design, Study Status, Eligibility, Outcome Measures and Conditions
11 February 6, 2019 Contacts/Locations and Study Status
12 April 10, 2019 Contacts/Locations and Study Status
13 May 14, 2019 Contacts/Locations, Eligibility, Outcome Measures and Study Status
14 February 11, 2020 Contacts/Locations and Study Status
15 May 20, 2020 Contacts/Locations, Study Status, References, Eligibility, Outcome Measures, Arms and Interventions, Conditions, Oversight and Study Identification
16 January 4, 2021 Contacts/Locations, Study Status and IPDSharing
17 January 18, 2022 Recruitment Status, Contacts/Locations, Study Status and IPDSharing
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Study NCT03006068
Submitted Date:  December 27, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: M14-533
Brief Title: A Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects With Ulcerative Colitis (UC)
Official Title: A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects With Ulcerative Colitis (UC)
Secondary IDs: 2016-000674-38 [EudraCT Number]
Open or close this module Study Status
Record Verification: December 2016
Overall Status: Enrolling by invitation
Study Start: December 2016
Primary Completion: January 2027 [Anticipated]
Study Completion: May 2029 [Anticipated]
First Submitted: December 20, 2016
First Submitted that
Met QC Criteria:
December 27, 2016
First Posted: December 30, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 27, 2016
Last Update Posted: December 30, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AbbVie
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study is designed to evaluate the long-term safety and efficacy of ABT-494 in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 (Substudies 1 and 2), who have had loss of response during the maintenance period of Study M14-234 (Substudy 3), or who have successfully completed Study M14-234.
Detailed Description:
Open or close this module Conditions
Conditions: Ulcerative Colitis (UC)
Keywords: ABT-494
Safety
Open-Label Extension (OLE)
Efficacy
Ulcerative Colitis (UC)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 950 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Participants receiving ABT-494 Dose A
The participants in this arm will receive ABT-494 dose A.
Drug: ABT-494
ABT-494 will be administered orally.
Experimental: Participants receiving ABT-494 Dose B
The participants in this arm will receive ABT-494 dose B.
Drug: ABT-494
ABT-494 will be administered orally.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Assessing Treatment-Emergent Adverse Events
[ Time Frame: Up to 288 Weeks ]

Treatment-emergent adverse events are defined as events that begin or worsen either on or after the first dose of the study drug and within 30 days after the last dose of the study drug in the analysis period.
Other Outcome Measures:
1. Proportion of participants achieving clinical remission per Adapted Mayo score
[ Time Frame: Up to Week 48 ]

It is defined as stool frequency subscore (SFS) <= 1, rectal bleeding subscore (RBS) of 0, and endoscopy subscore <= 1.
2. Proportion of participants achieving clinical response per Adapted Mayo score
[ Time Frame: Up to Week 48 ]

It is defined as decrease from baseline in Adapted Mayo score >= 2 points and >= 30%, accompanied by a decrease in RBS of >= 1 or an absolute RBS of 0 or 1.
3. Proportion of participants achieving clinical remission per Full Mayo score
[ Time Frame: Up to 48 Weeks ]

Clinical remission per full mayo score is defined as a Full Mayo score <= 2 with no subscore > 1.
4. Proportion of participants achieving clinical remission per Partial Mayo score
[ Time Frame: Up to 48 Weeks ]

It is defined as a Partial Mayo score <= 2 with no subscore > 1.
5. Proportion of participants achieving clinical response per Partial Mayo score
[ Time Frame: Up to 48 Weeks ]

It is defined as decrease from baseline in the Partial Mayo score >= 2 points and >= 30% from Baseline, PLUS a decrease in RBS >= 1 or an absolute RBS <= 1.
6. Proportion of participants in clinical remission per Adapted Mayo score at Week 0 who maintain remission at Week 48
[ Time Frame: At Week 48, and every 48 weeks thereafter through 288 weeks ]

Clinical remission per Adapted Mayo score is defined as SFS <= 1, RBS of 0, and endoscopy subscore <= 1.
7. Proportion of participants in clinical remission per Full Mayo score at Week 0 who maintain remission at Week 48
[ Time Frame: At Week 48, and every 48 weeks thereafter through 288 weeks ]

Clinical remission per Full Mayo score is defined as a Full Mayo score <= 2 with no subscore > 1.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 99 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Participant has not achieved clinical response at the end of the induction period (Week 8) in Study M14-234 (Sub-studies 1 and 2), has had loss of response during the maintenance period of Study M14-234 (Sub-study 3), or has successfully completed Study M14-234.
  • If female, participant must meet the criteria for Contraception Recommendations and Pregnancy Testing.
  • 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.
  • Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234).
  • Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria:

  • For any reason participant is considered by the investigator to be an unsuitable candidate.
  • Female participant with a positive pregnancy test at Baseline (final visit of Study M14-234) or who is considering becoming pregnant during the study.
  • Participant with an active or recurrent infection that based on the investigator's clinical assessment makes the participant an unsuitable candidate for the study. Participants with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
  • Current evidence of active or untreated latent tuberculosis.
  • Participant with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.
Open or close this module Contacts/Locations
Study Officials: AbbVie Inc
Study Director
AbbVie
Locations: United States, Louisiana
Site Reference ID/Investigator# 150526
Shreveport, Louisiana, United States, 71105
Australia
Site Reference ID/Investigator# 150218
Clayton, Australia, 3168
Site Reference ID/Investigator# 152503
Fitzroy, Australia, VIC 3065
Austria
Site Reference ID/Investigator# 150462
Linz, Austria, 4020
Site Reference ID/Investigator# 150463
Salzburg, Austria, A-5020
Site Reference ID/Investigator# 150616
Vienna, Austria, 1090
Site Reference ID/Investigator# 150615
Vienna, Austria, 1160
Brazil
Site Reference ID/Investigator# 152493
Botucatu, Brazil, 18618-686
Site Reference ID/Investigator# 153744
Goiania-Goias, Brazil, CEP:74535-170
Site Reference ID/Investigator# 152492
Ribeirao Preto, Brazil, 14048-900
Site Reference ID/Investigator# 152489
Santo Andre, Brazil, 09060-650
Site Reference ID/Investigator# 152491
Sao Jose do Rio Preto, Brazil, 15015-110
Japan
Site Reference ID/Investigator# 152728
Aichi, Japan
Site Reference ID/Investigator# 152525
Fukuoka-shi, Japan
Site Reference ID/Investigator# 152626
Higashiibaraki-gun, Japan
Site Reference ID/Investigator# 152761
Hirosaki-shi, Aomori, Japan
Site Reference ID/Investigator# 151952
Hiroshima-shi, Japan
Site Reference ID/Investigator# 152589
Kitakyushu-shi, Fukuoka, Japan
Site Reference ID/Investigator# 152048
Kobe-shi Hyogo, Japan
Site Reference ID/Investigator# 151909
Kofu-shi, Japan
Site Reference ID/Investigator# 151977
Kurume-shi,Fukuoka, Japan
Site Reference ID/Investigator# 152358
Kyoto, Japan
Site Reference ID/Investigator# 153195
Mitaka-shi, Japan
Site Reference ID/Investigator# 151994
Nagakute-shi, Japan
Site Reference ID/Investigator# 151949
Nagoya-shi, Japan
Site Reference ID/Investigator# 152433
Nishinomiya-shi, Hyogo, Japan
Site Reference ID/Investigator# 152703
Osaka-shi, Japan
Site Reference ID/Investigator# 152681
Osaka-shi, Osaka, Japan
Site Reference ID/Investigator# 152676
Saitama, Japan
Site Reference ID/Investigator# 151705
Sapporo-shi, Japan
Site Reference ID/Investigator# 152017
Tokyo, Japan
Site Reference ID/Investigator# 152584
Tokyo, Japan
Site Reference ID/Investigator# 152687
Tokyo, Japan
Korea, Republic of
Site Reference ID/Investigator# 150432
Daegu, Korea, Republic of, 42415
Site Reference ID/Investigator# 150431
Guri-si, Gyeonggi-do, Korea, Republic of, 11923
Site Reference ID/Investigator# 150434
Paldal-gu, Suwon,Gyeonggi-do, Korea, Republic of, 16247
Site Reference ID/Investigator# 150435
Seoul, Korea, Republic of, 03181
Site Reference ID/Investigator# 150433
Seoul, Korea, Republic of, 06351
Portugal
Site Reference ID/Investigator# 151622
Almada, Portugal, 2805-267
Site Reference ID/Investigator# 151616
Guimaraes, Portugal, 4835-044
Site Reference ID/Investigator# 151615
Lisbon, Portugal, 1649-035
Site Reference ID/Investigator# 151619
Porto, Portugal, 4200-319
Site Reference ID/Investigator# 151618
Viana Do Castelo, Portugal, 4901-858
Slovakia
Site Reference ID/Investigator# 150869
Banska Bystrica, Slovakia, 975 17
Site Reference ID/Investigator# 150550
Bratislava, Slovakia, 85101
Site Reference ID/Investigator# 150240
Ilava, Slovakia, 019 01
Site Reference ID/Investigator# 150584
Kosice, Slovakia, 040 22
Site Reference ID/Investigator# 150585
Presov, Slovakia, 080 01
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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