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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

NCT03695185 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-03-15

Study results available
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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.

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

Ravagalimab 600 mg

Ravagalimab 600 mg was administered intravenously (IV).

DRUG

Ravagalimab 300 mg

Ravagalimab 300 mg was administered subcutaneously (SC).

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2021-04-05
Completion
2022-01-10
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03695185 on ClinicalTrials.gov