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History of Changes for Study: NCT05629208
Study of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)
Latest version (submitted June 3, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 17, 2022 None (earliest Version on record)
2 December 6, 2022 Study Status and References
3 February 2, 2023 Study Status and Oversight
4 April 21, 2023 Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures, Study Description and Study Identification
5 June 27, 2023 Study Status
6 July 12, 2023 Study Status
7 August 16, 2023 Study Status
8 September 8, 2023 Study Status and Study Identification
9 October 19, 2023 Study Status and Contacts/Locations
10 November 9, 2023 Study Status and Contacts/Locations
11 December 4, 2023 Contacts/Locations and Study Status
12 December 15, 2023 Contacts/Locations and Study Status
13 January 4, 2024 Contacts/Locations and Study Status
14 January 25, 2024 Contacts/Locations and Study Status
15 February 13, 2024 Study Status and Contacts/Locations
16 February 22, 2024 Contacts/Locations and Study Status
17 March 13, 2024 Study Status
18 April 3, 2024 Study Status and Contacts/Locations
19 May 14, 2024 Study Status and Contacts/Locations
20 June 3, 2024 Study Status
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Study NCT05629208
Submitted Date:  November 17, 2022 (v1)
Open or close this module Study Identification
Unique Protocol ID: GS-US-497-6486
Brief Title: Study of GS-5718 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)
Secondary IDs: 2022-501523-24-00 [European Medicines Agency]
Open or close this module Study Status
Record Verification: November 2022
Overall Status: Not yet recruiting
Study Start: March 2023
Primary Completion: December 2024 [Anticipated]
Study Completion: December 2024 [Anticipated]
First Submitted: November 17, 2022
First Submitted that
Met QC Criteria:		 November 17, 2022
First Posted: November 29, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:		 November 17, 2022
Last Update Posted: November 29, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gilead Sciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The goal of this study is to test how 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:
Open or close this module Conditions
Conditions: Cutaneous Lupus Erythematosus (CLE)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Care Provider)
Allocation: Randomized
Enrollment: 33 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: GS-5718
Participants will receive GS-5718 30 mg, once daily starting on Day 1 for up to 12 weeks.
 Drug: GS-5718
Tablets administered orally
Placebo Comparator: GS-5718 Placebo
Participants will receive GS-5718 placebo, once daily starting on Day 1 for up to 12 weeks.
 Drug: GS-5718 Placebo
Tablets administered orally
Open or close this module Outcome Measures
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 GS-5718
[ Time Frame: Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day) ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Gilead Clinical Study Information Center
Telephone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Study Officials: Gilead Study Director
Study Director
Gilead Sciences
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services