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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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