search
Back to results

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

Primary Purpose

Cutaneous Lupus Erythematosus (CLE)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Edecesertib
Edecesertib Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Lupus Erythematosus (CLE)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Either fulfill European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) and/or have biopsy confirmed Cutaneous Lupus Erythematosus (CLE) at any time. Must have active CLE at screening and Day 1. Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas. Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening. Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points. Must have documented prior intolerance or inadequate response at any time (per investigator judgement) to protocol-specified treatments. Topical corticosteroids or topical calcineurin inhibitors. Oral corticosteroids. Any other nonbiologic standard-of-care therapy, including, but not limited to: chloroquine, quinacrine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX). Individuals willing to comply with all study visits and assessments. Key Exclusion Criteria: Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/or localized acute CLE involving only 1 distinct body area at screening and Day 1. Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis). Presence of active skin conditions other than cutaneous lupus that may interfere with assessing lupus-specific skin lesion(s) (eg, psoriasis, and/or drug-induced lupus). Meet protocol-specified infection or lab criteria. Any active infection that is clinically significant (per investigator judgment). Any history of clinically significant liver disease. Significant cardiovascular disease. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Clinical Research of West Florida, Inc.Recruiting
  • Dawes Fretzin Clinical Research Group, LLCRecruiting
  • Metroplex Clinical Research CenterRecruiting
  • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Edecesertib

Edecesertib Placebo

Arm Description

Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.

Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
The CLASI is a standardized, validated measure of cutaneous lupus disease activity and damage, widely used in clinical trials. CLASI consists of CLASI - activity (A) and - damage (D) measurements. CLASI-A scores range from 0 to 70, with higher scores indicating more severe disease activity.

Secondary Outcome Measures

Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12
The CLA-IGA is a measure of cutaneous lupus erythematosus (CLE) activity and will be recorded on a scale of 0 to 4, with 0 indicating "clear" and 4 indicating "severe".
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs)
Percentage of Participants Experiencing Laboratory Abnormalities
Plasma Concentration of Edecesertib

Full Information

First Posted
November 17, 2022
Last Updated
October 19, 2023
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05629208
Brief Title
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Official Title
A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE. Information on what is happening in the body relating to CLE, how the body processes, is affected by and responds to the study drug, and any study drug side effects will also be collected in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Lupus Erythematosus (CLE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Edecesertib
Arm Type
Experimental
Arm Description
Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.
Arm Title
Edecesertib Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Edecesertib
Other Intervention Name(s)
GS-5718
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Edecesertib Placebo
Intervention Description
Tablets administered orally
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
Description
The CLASI is a standardized, validated measure of cutaneous lupus disease activity and damage, widely used in clinical trials. CLASI consists of CLASI - activity (A) and - damage (D) measurements. CLASI-A scores range from 0 to 70, with higher scores indicating more severe disease activity.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12
Description
The CLA-IGA is a measure of cutaneous lupus erythematosus (CLE) activity and will be recorded on a scale of 0 to 4, with 0 indicating "clear" and 4 indicating "severe".
Time Frame
Week 12
Title
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame
First dose date up to 12 weeks plus 30 days
Title
Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs)
Time Frame
First dose date up to 12 weeks plus 30 days
Title
Percentage of Participants Experiencing Laboratory Abnormalities
Time Frame
First dose date up to 12 weeks plus 30 days
Title
Plasma Concentration of Edecesertib
Time Frame
Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Either fulfill European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) and/or have biopsy confirmed Cutaneous Lupus Erythematosus (CLE) at any time. Must have active CLE at screening and Day 1. Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas. Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening. Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points. Must have documented prior intolerance or inadequate response at any time (per investigator judgement) to protocol-specified treatments. Topical corticosteroids or topical calcineurin inhibitors. Oral corticosteroids. Any other nonbiologic standard-of-care therapy, including, but not limited to: chloroquine, quinacrine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX). Individuals willing to comply with all study visits and assessments. Key Exclusion Criteria: Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/or localized acute CLE involving only 1 distinct body area at screening and Day 1. Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis). Presence of active skin conditions other than cutaneous lupus that may interfere with assessing lupus-specific skin lesion(s) (eg, psoriasis, and/or drug-induced lupus). Meet protocol-specified infection or lab criteria. Any active infection that is clinically significant (per investigator judgment). Any history of clinically significant liver disease. Significant cardiovascular disease. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-497-6486
Description
Gilead Clinical Trials Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs