Trials / Terminated
TerminatedNCT04809623
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
A Randomized, Blinded, Placebo-Controlled, Phase 1b Study of GS-5718 in Subjects With Cutaneous Lupus Erythematosus (CLE)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and tolerability of edecesertib (formerly GS-5718) in participants with cutaneous lupus erythematosus (CLE) with or without systemic lupus erythematosus (SLE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Edecesertib | Tablets administered orally |
| DRUG | Placebo | Placebo to match edecesertib tablets administered orally |
| DRUG | Standard of Care | Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone) |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2022-10-18
- Completion
- 2022-10-18
- First posted
- 2021-03-22
- Last updated
- 2024-04-05
- Results posted
- 2024-04-05
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04809623. Inclusion in this directory is not an endorsement.