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Phase 2 Completed N=42 Treatment

A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Ulcerative Colitis (UC)
Source: ClinicalTrials.gov NCT03695185 ↗
Enrolled (actual)
42
Serious AEs
5.6%
Results posted
Mar 2023
Primary outcomePrimary: Percentage of Participants With Endoscopic Improvement During Induction Period — 18.0 percentage of participants

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Endoscopic Improvement During Induction Period
18.0
SECONDARY
Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period
9.5
SECONDARY
Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period
40.2
SECONDARY
Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score
57.1
SECONDARY
Percentage of Participants With Clinical Remission Per Full Mayo Score During Induction Period in Participants With a Full Mayo Score of 6 to 12 at Baseline
7.5
SECONDARY
Percentage of Participants With Endoscopic Remission During Induction Period
0.0

Eligibility Criteria

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) = 3.0*10^9/L.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03695185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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