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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03006068




Registration number
NCT03006068
Ethics application status
Date submitted
20/12/2016
Date registered
30/12/2016
Date last updated
6/01/2021

Titles & IDs
Public title
A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)
Scientific title
A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis
Secondary ID [1] 0 0
2016-000674-38
Secondary ID [2] 0 0
M14-533
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib (ABT-494)
Treatment: Drugs - Placebo

Experimental: Participants receiving Upadacitinib (ABT-494) Dose A - The participants in this arm will receive Upadacitinib (ABT-494) dose A.

Experimental: Participants receiving Upadacitinib (ABT-494) Dose B - The participants in this arm will receive Upadacitinib (ABT-494) dose B.

Experimental: Participants receiving Upadacitinib (ABT-494) Dose C - The participants in this arm will receive Upadacitinib (ABT-494) dose C.

Experimental: Participants receiving Placebo - The participants in this arm will receive placebo until study is unblinded.

Experimental: Participants receiving Upadacitinib (ABT-494) Dose A or Dose B - The participants in this arm will receive Upadacitinib (ABT-494) dose A or dose B.


Treatment: Drugs: Upadacitinib (ABT-494)
Upadacitinib (ABT-494) will be administered orally.

Treatment: Drugs: Placebo
Placebo will be administered orally.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessing Treatment-Emergent Adverse Events - 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.
Timepoint [1] 0 0
Up to 288 Weeks

Eligibility
Key inclusion criteria
Note: Participants aged 16 or 17 may enroll in M14-234 or M14-675 where locally permissible

- Participant has not achieved clinical response at the end of the induction period
(Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance
period of Study M14-234 Substudy 3, or has successfully completed Study M14-234
Substudy 3. During the COVID-19 pandemic, for participants with missing endoscopy at
Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2,
M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are
met.

- If female, participant must meet the criteria for Contraception Recommendations.

- Women of childbearing potential must have a negative urine pregnancy test at Week 0
visit.

- 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.
Minimum age
16 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- For any reason participant is considered by the investigator to be an unsuitable
candidate.

- Female participant with a positive pregnancy test at the final visit of Study M14-234
or who is considering becoming pregnant during the study or within 30 days after the
last dose of study drug.

- 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 tuberculosis (TB); current evidence of latent tuberculosis
and for any reason the participant cannot take full course of TB prophylaxis treatment
as required per protocol.

- Participant with a poorly controlled medical condition, such as uncontrolled diabetes,
unstable ischemic heart disease, moderate or severe congestive heart failure (New York
Heart Association class III or IV), 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.

- Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of
the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of
Study M14-234.

- History of any malignancy except for successfully treated nonmelanoma skin cancer
(NMSC) or localized carcinoma in situ of the cervix from evaluations performed in
Study M14-234.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University /ID# 211953 - Macquarie Park
Recruitment hospital [2] 0 0
Mater Misericordiae /ID# 212686 - South Brisbane
Recruitment hospital [3] 0 0
Griffith University /ID# 211954 - Southport
Recruitment hospital [4] 0 0
Monash Health /ID# 150218 - Clayton
Recruitment hospital [5] 0 0
St. Vincents Hosp Melbourne /ID# 152503 - Fitzroy
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 211641 - Murdoch
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
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4222 - Southport
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3168 - Clayton
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3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
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State/province [212] 0 0
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Country [213] 0 0
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State/province [213] 0 0
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Country [214] 0 0
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State/province [214] 0 0
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Country [215] 0 0
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State/province [215] 0 0
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Country [216] 0 0
Russian Federation
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Country [217] 0 0
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Beograd
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State/province [226] 0 0
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Country [227] 0 0
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State/province [227] 0 0
Leskovac
Country [228] 0 0
Singapore
State/province [228] 0 0
Singapore
Country [229] 0 0
Slovakia
State/province [229] 0 0
Bratislavsky Kraj
Country [230] 0 0
Slovakia
State/province [230] 0 0
Banska Bystrica
Country [231] 0 0
Slovakia
State/province [231] 0 0
Ilava
Country [232] 0 0
Slovakia
State/province [232] 0 0
Kosice
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Slovakia
State/province [233] 0 0
Nove Zamky
Country [234] 0 0
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State/province [234] 0 0
Presov
Country [235] 0 0
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Gauteng
Country [236] 0 0
South Africa
State/province [236] 0 0
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Country [237] 0 0
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State/province [237] 0 0
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State/province [238] 0 0
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State/province [239] 0 0
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Country [240] 0 0
Spain
State/province [240] 0 0
Barcelona
Country [241] 0 0
Spain
State/province [241] 0 0
Cordoba
Country [242] 0 0
Spain
State/province [242] 0 0
Las Palmas de Gran Canaria
Country [243] 0 0
Spain
State/province [243] 0 0
Madrid
Country [244] 0 0
Spain
State/province [244] 0 0
Salamanca
Country [245] 0 0
Spain
State/province [245] 0 0
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Country [246] 0 0
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State/province [246] 0 0
Goteborg
Country [247] 0 0
Switzerland
State/province [247] 0 0
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Switzerland
State/province [248] 0 0
Zuerich
Country [249] 0 0
Switzerland
State/province [249] 0 0
Basel
Country [250] 0 0
Switzerland
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Bern
Country [251] 0 0
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State/province [251] 0 0
Taichung
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Tainan
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Taiwan
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Taipei
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Taiwan
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Taipei City
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Turkey
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Turkey
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Turkey
State/province [261] 0 0
Mersin
Country [262] 0 0
Ukraine
State/province [262] 0 0
Kharkivska Oblast
Country [263] 0 0
Ukraine
State/province [263] 0 0
Kyivska Oblast
Country [264] 0 0
Ukraine
State/province [264] 0 0
Kyiv
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Ukraine
State/province [265] 0 0
Vinnytska Oblast
Country [266] 0 0
Ukraine
State/province [266] 0 0
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Country [267] 0 0
Ukraine
State/province [267] 0 0
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Country [268] 0 0
Ukraine
State/province [268] 0 0
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Country [269] 0 0
Ukraine
State/province [269] 0 0
Odesa
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Ukraine
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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Bath
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United Kingdom
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Birmingham
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Huddersfield
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United Kingdom
State/province [278] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in
participants with ulcerative colitis (UC) who have not responded at the end of the induction
period in Study M14-234 Substudy 1, who have had loss of response during the maintenance
period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy
3.
Trial website
https://clinicaltrials.gov/show/NCT03006068
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03006068