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Trial record 1 of 2 for:    M14-234
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A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis (UC)

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ClinicalTrials.gov Identifier: NCT03006068
Recruitment Status : Enrolling by invitation
First Posted : December 30, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : January 7, 2022
Estimated Study Completion Date : July 20, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants receiving Upadacitinib (ABT-494) Dose A
The participants in this arm will receive Upadacitinib (ABT-494) dose A.
Drug: Upadacitinib (ABT-494)
Upadacitinib (ABT-494) will be administered orally.
Other Name: Upadacitinib

Experimental: Participants receiving Upadacitinib (ABT-494) Dose B
The participants in this arm will receive Upadacitinib (ABT-494) dose B.
Drug: Upadacitinib (ABT-494)
Upadacitinib (ABT-494) will be administered orally.
Other Name: Upadacitinib




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 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.

  2. 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 and not greater than baseline, rectal bleeding subscore (RBS) of 0, and endoscopy subscore <= 1 evidence of friability during endoscopy in subjects with otherwise "mild" endoscopic activity will confer an endoscopic subscore of 2.

  3. 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.

  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 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.

  6. 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.

  7. 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%, PLUS a decrease in RBS of >= 1 or an absolute RBS of <= 1.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.
  • 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.

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 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.
  • 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.

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): NCT03006068


  Show 399 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03006068     History of Changes
Other Study ID Numbers: M14-533
2016-000674-38 ( EudraCT Number )
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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

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