Phase 2
Completed N=42
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
| Outcome | Result | p-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.
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.