A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT03006068
• Date of registration: 20/12/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• 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
• Date of first enrolment: January 31, 2017
• Target sample size: 950
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03006068
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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 contraception criteria.

- 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.

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.

- Known hypersensitivity to upadacitinib or its excipients or had any adverse event (AE)
during the preceding studies, that in the investigator's judgment makes the
participant unsuitable for this 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 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.



Age minimum: 16 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)

Intervention(s)

Drug: Placebo

Drug: Upadacitinib (ABT-494)

Primary Outcome(s)

Assessing Treatment-Emergent Adverse Events [Time Frame: Up to 288 Weeks]

Secondary ID(s)

2016-000674-38

M14-533

Source(s) of Monetary Support

Please refer to primary and secondary sponsors