Trials / Terminated
TerminatedNCT04790916
Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)
A Double-Blind, Randomized, Parallel-Group, Phase 2 Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune Hepatitis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the effect of RO7049665 on time to relapse following forced corticosteroid (CCS) tapering as measured by the hazard ratio between RO7049665 7.5 milligrams (mg) and placebo arm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RO7049665 | RO7049665, subcutaneous injection, Q2W. |
| OTHER | Placebo | RO7049665-matching placebo, subcutaneous injection, Q2W. |
Timeline
- Start date
- 2021-04-19
- Primary completion
- 2021-11-18
- Completion
- 2021-11-18
- First posted
- 2021-03-10
- Last updated
- 2023-09-18
- Results posted
- 2023-09-18
Locations
14 sites across 8 countries: Australia, Canada, Germany, Italy, Netherlands, Portugal, South Korea, United Kingdom
Source: ClinicalTrials.gov record NCT04790916. Inclusion in this directory is not an endorsement.