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)

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Study Record Versions

Version	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

Comparison Format:

Merged
Side-by-Side

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]

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]

Sponsor/Collaborators


Sponsor:	AbbVie
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

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:

Conditions


Conditions:	Ulcerative Colitis (UC)
Keywords:	ABT-494 Safety Open-Label Extension (OLE) Efficacy Ulcerative Colitis (UC)

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]

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.

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.

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.

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

IPDSharing


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References


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