Summary

for people ages 18-75 (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

Study M15-722 is a Phase 2a study to investigate the efficacy and safety of ABBV-323 in participants with moderate to severe UC who failed prior therapy.

Official Title

A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Keywords

Ulcerative Colitis (UC) ABBV-323 Colitis Colitis, Ulcerative Ulcer ABBV-323 Dose A ABBV-323 Dose B

Eligibility

You can join if…

Open to people ages 18-75

  • Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
  • Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
  • Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
  • History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug).

You CAN'T join if...

  • Participant having an active, chronic, or recurrent infection that based on Investigator's clinical assessment makes the participant an unsuitable candidate for the study.
  • Participant having any malignancy except for successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
  • Participant with history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy performed during the screening endoscopy other than completely removed low-grade dysplastic lesions.
  • Laboratory values not meeting the following criteria : Serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2 upper limit of normal (ULN); Total white blood cell (WBC) count >= 3.0109/L.

Locations

  • UC Davis Medical Center /ID# 209402 accepting new patients
    Sacramento California 95817 United States
  • TLC Clinical Research Inc /ID# 206626 accepting new patients
    Beverly Hills California 90211-2091 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Sign up for this study
ID
NCT03695185
Phase
Phase 2
Study Type
Interventional
Last Updated