Trial Outcomes & Findings for Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE) (NCT NCT04809623)

Results Overview

Treatment-emergent Adverse Events (TEAEs) were defined as AEs with onset dates on or after the study treatment start date and no later than 28 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatments.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

3 participants

Primary outcome timeframe

First dose date up to 4 weeks plus 28 days

Results posted on

2024-04-05

Participant Flow

Participants were enrolled at sites in the United States.

7 participants were screened.

Participant milestones

Participant milestones
Measure	Edecesertib Participants received edecesertib at a dose of 115 mg orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy.	Placebo Participants received placebo to match edecesertib orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy.
Overall Study STARTED	2	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Edecesertib Participants received edecesertib at a dose of 115 mg orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy.	Placebo Participants received placebo to match edecesertib orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy.
Overall Study Study Terminated by Sponsor	1	0

Baseline Characteristics

Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Edecesertib n=2 Participants Participants received edecesertib at a dose of 115 mg orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy.	Placebo n=1 Participants Participants received placebo to match edecesertib orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy.	Total n=3 Participants Total of all reporting groups
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race/Ethnicity, Customized	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants

PRIMARY outcome

Timeframe: First dose date up to 4 weeks plus 28 days

Population: No data was reported for adverse events due to low number of participants in both Edicescertib and Placebo arms, in order to protect and maintain participant privacy/confidentiality.

Treatment-emergent Adverse Events (TEAEs) were defined as AEs with onset dates on or after the study treatment start date and no later than 28 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatments.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: First dose date up to 4 weeks plus 28 days

Population: No data was reported for adverse events due to low number of participants in both Edicescertib and Placebo arms, in order to protect and maintain participant privacy/confidentiality.

A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 28 days after last study drug administration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and up to 6 hours postdose at Week 4

Population: Data not reported for participant confidentiality reasons.

AUCtau is defined as the area under the concentration versus time curve over the dosing interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and up to 6 hours postdose at Week 4

Population: Data not reported for participant confidentiality reasons.

Cmax is defined as the maximum observed concentration of drug.

Outcome measures

Outcome data not reported

Adverse Events

Edecesertib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years.
Publication restrictions are in place

Restriction type: OTHER