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

Ulcerative Colitis (UC)
42 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Single Group Assignment
None (Open Label)


Eligibility criteria

Participant attributes:
Male and Female


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

- 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

- 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


More information about this study