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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 : April 4, 2024
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Erythematosus (CLE) Drug: Edecesertib Drug: Edecesertib Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 17, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Edecesertib
Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.
 Drug: Edecesertib
Tablets administered orally
Other Name: GS-5718
Placebo Comparator: Edecesertib Placebo
Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.
 Drug: Edecesertib Placebo
Tablets administered orally


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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".

  2. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 12 weeks plus 30 days ]
  3. Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs) [ Time Frame: First dose date up to 12 weeks plus 30 days ]
  4. Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: First dose date up to 12 weeks plus 30 days ]
  5. Plasma Concentration of Edecesertib [ Time Frame: Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05629208


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05629208    
Other Study ID Numbers: GS-US-497-6486
2022-501523-24 ( Other Identifier: European Medicines Agency )
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: April 4, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Skin Diseases