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

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ClinicalTrials.gov Identifier: NCT05629208
Recruitment Status : Recruiting
First Posted : November 29, 2022
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE November 17, 2022
First Posted Date  ICMJE November 29, 2022
Last Update Posted Date May 16, 2024
Actual Study Start Date  ICMJE April 17, 2023
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2022)		 Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 [ Time Frame: Baseline, 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2023)
  • Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12 [ Time Frame: 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) [ Time Frame: First dose date up to 12 weeks plus 30 days ]
  • Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs) [ Time Frame: First dose date up to 12 weeks plus 30 days ]
  • Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: First dose date up to 12 weeks plus 30 days ]
  • Plasma Concentration of Edecesertib [ Time Frame: Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2022)
  • Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12 [ Time Frame: 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) [ Time Frame: First dose date up to 12 weeks plus 30 days ]
  • Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs) [ Time Frame: First dose date up to 12 weeks plus 30 days ]
  • Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: First dose date up to 12 weeks plus 30 days ]
  • Plasma Concentration of GS-5718 [ Time Frame: Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Lupus Erythematosus (CLE)
Intervention  ICMJE
  • Drug: Edecesertib
    Tablets administered orally
    Other Name: GS-5718
  • Drug: Edecesertib Placebo
    Tablets administered orally
Study Arms  ICMJE
  • Experimental: Edecesertib
    Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.
    Intervention: Drug: Edecesertib
  • Placebo Comparator: Edecesertib Placebo
    Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.
    Intervention: Drug: Edecesertib Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2022)		 33
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Czechia,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05629208
Other Study ID Numbers  ICMJE GS-US-497-6486
2022-501523-24 ( Other Identifier: European Medicines Agency )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Gilead Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gilead Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP