Trials / Completed
CompletedNCT03695185
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
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ravagalimab 600 mg | Ravagalimab 600 mg was administered intravenously (IV). |
| DRUG | Ravagalimab 300 mg | Ravagalimab 300 mg was administered subcutaneously (SC). |
Timeline
- Start date
- 2019-03-26
- Primary completion
- 2021-04-05
- Completion
- 2022-01-10
- First posted
- 2018-10-04
- Last updated
- 2023-03-15
- Results posted
- 2023-03-15
Locations
34 sites across 10 countries: United States, Canada, France, Germany, Hungary, Italy, Netherlands, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03695185. Inclusion in this directory is not an endorsement.