NCT03695185

A Study to Investigate How Well an Active Drug Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Brief summary

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

Interventional study

Status:
Completed
Conditions:
Ulcerative Colitis (UC)
Enrollment:
42 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-722
Allocation:
N/A
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

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 >= 3.0*10^9/L.

All the cities where the clinical studies are located

Toronto - M5G 1X5

Ontario