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Clinical Trials/NL-OMON49261
NL-OMON49261
Completed
Phase 2

A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy - M15-722

AbbVie B.V.0 sites6 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
AbbVie B.V.
Enrollment
6
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial ended prematurely

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •· Subjects 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.
  • •· Adult male or female, between 18 and 75 years of age, inclusive, at time of
  • •the Baseline visit.
  • •· Diagnosis of UC for at least 3 months prior to Baseline. Appropriate
  • •documentation of biopsy results consistent with the diagnosis of UC or in the
  • •assessment of the Investigator, must be available.
  • •· Subject 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

Exclusion Criteria

  • •\- Subject must not have an active, chronic, or recurrent infection that based
  • •on the Investigator's clinical assessment makes the subject an unsuitable
  • •candidate for the study
  • •\- Subject must not have any malignancy except for successfully treated non
  • •metastatic cutaneous squamous cell or basal cell carcinoma or localized
  • •carcinoma in situ of the cervix.
  • •\- Subject must not have history of dysplasia of the gastrointestinal tract or
  • •evidence of dysplasia in any biopsy performed during the Screening endoscopy

Outcomes

Primary Outcomes

Not specified

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