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

NCT04809623 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: GS-US-497-58882021-000204-38
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

Brief 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

Cutaneous Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Experienced Treatment-emergent Adverse Events

  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.

  First dose date up to 4 weeks plus 28 days

• Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities

  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.

  First dose date up to 4 weeks plus 28 days

Secondary Outcomes (2)

• Pharmacokinetic (PK) Parameter: AUCtau of Edecesertib

  Predose and up to 6 hours postdose at Week 4

• Pharmacokinetic (PK) Parameter: Cmax of Edecesertib

  Predose and up to 6 hours postdose at Week 4

Study Arms (2)

Edecesertib

EXPERIMENTAL

Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks.

Drug: Edecesertib; Drug: Standard of Care

Placebo

EXPERIMENTAL

Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks.

Drug: Placebo; Drug: Standard of Care

Interventions

Edecesertib DRUG

Tablets administered orally

Also known as: GS-5718

Edecesertib

Placebo DRUG

Placebo to match edecesertib tablets administered orally

Placebo

Standard of Care DRUG

Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone)

Edecesertib; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either fulfill the European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) or have biopsy-proven cutaneous lupus erythematosus (CLE).
• Must have active acute cutaneous lupus erythematosus (ACLE)/ subacute cutaneous lupus erythematosus (SCLE); individuals with mixed skin presentations of lupus skin disease (including DLE) are allowed to enter.
• CLE Disease Area and Severity Index (CLASI) activity score of ≥ 6 during screening and Day 1, excluding the alopecia component.
• Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and willingness to undergo skin biopsy at 2 time points.
• Protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents for the treatment of CLE/SLE (eg, antimalarials, methotrexate (MTX), or other conventional synthetic disease-modifying antirheumatic drug (csDMARDs)) must maintain stable dose(s) for ≥ 60 days prior to randomization through Week 4 of the study.

You may not qualify if:

• Dermatologic disease other than cutaneous manifestations of SLE or CLE that may interfere with assessment of lupus-specific skin lesions.
• Ongoing or active clinically significant bacterial, fungal or viral infection.
• History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
• Uncontrolled health conditions including highly active SLE (e.g. lupus nephritis, neuropsychiatric SLE, vasculitis etc.).
• History of malignancy.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (5)

Wallace Rheumatic Studies Center, LLC

Beverly Hills, California, 90211, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Dawes Fretzin Clincial Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28210, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

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

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: September 1, 2021
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)