A Study of Experimental ABBV-323 For Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

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Age: 18 to 75 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Moderate to Severe Ulcerative Colitis, Severe Ulcerative Colitis, Ulcerative Colitis
Type: Drug study, Phase 2
Target:
2 Participants
Investigator:
Description
We invite you to take part in a research study because you have been diagnosed with ulcerative colitis. Symptoms include diarrhea with or without blood, abdominal pain, and a sudden or constant feeling that you need to move your bowels.

This study is for patients who did not respond to treatment with medications that help reduce the inflammation. These medications include infliximab, adalimumab, golimumab, vedolizumab or tofacitinib.

The experimental drug or “study drug” is called ABBV-323. It is being studied to treat subjects with moderately to severely active ulcerative colitis. An experimental drug is one that has not been approved by the FDA.

This experimental drug or “study drug” belongs to a group of medications called a biologic. ABBV-323 is made in a laboratory and is the same as a protein found in your body called an antibody.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • 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).

Exclusion criteria:

  • 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 >= 3.010^9/L.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $58.00 for each visit completed for your time and effort.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for up to 69 weeks. There will be a Screening Period of up to 5 weeks, a 12-week induction period, and a 40-week maintenance period.
Recruitment period
From Sept. 3, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Sophia Zaragoza
Research Topic
Conditions:
  • Ulcerative Colitis (UC)