Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
33
Countries
3
Sites
9
Cutaneous Lupus Erythematosus (CLE)
To evaluate the efficacy of GS-5718 versus PTM in reducing skin disease activity for participants with CLE with or without SLE.
Key facts
- Sponsor
- Gilead Sciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 12 Oct 2023 → 15 Jan 2026
- Decision date (initial)
- 2023-09-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Gilead Sciences, Inc.
External identifiers
- EU CT number
- 2022-501523-24-00
- ClinicalTrials.gov
- NCT05629208
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety
To evaluate the efficacy of GS-5718 versus PTM in reducing skin disease activity for participants with CLE with or without SLE.
Secondary objectives 3
- To evaluate the efficacy of GS-5718 versus PTM in reducing skin disease activity for participants with CLE with or without SLE.
- To evaluate the safety and tolerability of GS-5718 in participants with CLE with or without SLE.
- To characterize the PK of GS-5718 in participants with CLE with or without SLE.
Conditions and MedDRA coding
Cutaneous Lupus Erythematosus (CLE)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10056509 | Cutaneous lupus erythematosus | 100000004858 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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. Note: Other protocol defined Inclusion criteria may apply.
Exclusion criteria 6
- 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 Exclusion criteria may apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at Week 12.
Secondary endpoints 5
- Proportion of participants with Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) score of 0 or 1 at Week 12.
- Incidence of treatment-emergent adverse events (TEAEs).
- Incidence of treatment-emergent serious adverse events (TESAEs).
- Incidence of treatment-emergent laboratory abnormalities.
- PK characteristics of GS-5718
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
GS-5718 film-coated tablets 15mg
PRD8854728 · Product
- Active substance
- GS-5718-03
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- GILEAD SCIENCES INC
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gilead Sciences Inc.
- Sponsor organisation
- Gilead Sciences Inc.
- Address
- 333 Lakeside Drive
- City
- Foster City
- Postcode
- 94404-1147
- Country
- United States
Scientific contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Public contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Crisalis LLC ORG-100047297
|
Oklahoma City, United States | E-data capture |
| Canfield Scientific Inc. ORG-100042834
|
Parsippany, United States | E-data capture |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other, Laboratory analysis |
| Ixcells Biotechnologies USA Inc. ORG-100048161
|
San Diego, United States | Laboratory analysis |
| Signant Health Management Limited ORG-100040504
|
Reading, United Kingdom | Interactive response technologies (IRT), E-data capture |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | On site monitoring, Code 12, Code 13, Code 2, Code 5 |
| Precision For Medicine Inc. ORG-100041895
|
Frederick, United States | Laboratory analysis |
| Mosaic Laboratories LLC ORG-100042385
|
Lake Forest, United States | Laboratory analysis |
Locations
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 4 | 2 |
| Germany | Ended | 8 | 3 |
| Spain | Ended | 8 | 4 |
| Rest of world
United States, Canada
|
— | 13 | — |
Investigational sites
Kozni ambulance Fialova s.r.o.
n/a, Evropska 1724/59, Dejvice, Prague
Vseobecna Fakultni Nemocnice V Praze
Dermatovenerologická klinika, U Nemocnice 499/2, Nove Mesto, Prague
Medical Center - University Of Freiburg
Clinic for Dermatology and Venereology, Hauptstrasse 7, Herdern, Freiburg Im Breisgau
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Clinic and Polyclinic for Dermatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaet Leipzig
Clinic for Dermatology, Venereology and Allergology, Philipp-Rosenthal-Strasse 23, Zentrum-Suedost, Leipzig
Hospital Universitario De Navarra
Internal Medicine, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario Infanta Leonor
Dermatology, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital De La Santa Creu I Sant Pau
Dermatology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital General De Granollers
Dermatology, Calle De Francesc Ribas 1, 08402, Granollers
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2023-10-24 | 2024-12-02 | 2023-11-09 | 2024-12-02 | |
| Germany | 2023-10-12 | 2024-01-16 | 2025-12-03 | ||
| Spain | 2023-11-06 | 2023-11-28 | 2025-12-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 48 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-501523-24-00_redacted | 2 |
| Recruitment arrangements (for publication) | K1_GS-US-497-6486_CZE_Recruitment and Informed consent procedure_29May2023_Public | n/a |
| Recruitment arrangements (for publication) | K1_GS-US-497-6486_Recruitment-Arrangements_ES_Public | N/A |
| Recruitment arrangements (for publication) | K1_GS-US-497-6486_Recruitment-Informed-Consent-Procedure_DE_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Brochure EU_ES_Spain_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Brochure with travel and stipend EU_Czech_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Brochure with travel and stipend_EU_DE_German_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Brochure with travel EU_ES_Spain_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Brochure_EU_DE_German_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Flyer with travel and stipend_Czech_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Flyer with travel and stipend_DE_German_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Flyer with travel and stipend_ES_Spain_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Flyer with travel_DE_German_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Flyer with travel_ES-Spain_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Poster with travel and stipend_Czech_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Poster with travel and stipend_DE_German_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Poster with travel and stipend_ES_Spain_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Poster with travel_DE_German_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 CLE Poster with travel_ES_Spain_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_GS-US-497-6486 Physician Letter_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-467-6486_Greenphire_ICF_ES_Spain_Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Future-Research-ICF_DE_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_GDPR-ICF_CZ_Czech_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Greenphire-ICF_CZ_Czech_Public | 8.2 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Greenphire-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Main ICF_ES_Spain_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Main-ICF_CZ_Czech_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Main-ICF_DE_German_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Optional-Skin-Biopsy ICF_CZ_Czech_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Optional-Skin-Biopsy-ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Partner ICF_ES_Spain_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Partner-Pregnancy-ICF_CZ_Czech_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Pregnant-Partner-ICF_DE_German_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Pregnant-Patient-ICF_DE_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_GS-US-497-6486_Skin Biopsy_Optional Substudy_ ICF_ES_Spain_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_ClinCard-Card-Carrier_CZ_Czech_Public | 10.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_ClinCard-Cardholder-FAQ_CZ_Czech_Public | 10.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_ClinCard-Cardholder-Msg-Templates_CZ_Czech_Public | 10.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_ClinCard-Fee-Schedule_CZ_Czech_Public | 10.1 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_ClinCard-Generic-Image_Public | 10.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_ConneX-Travel-Contact-Card_CZ_Czech_Public | 10.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_ConneX-Travel-Reference-Guide-for-Participants_CZ_Czech_Public | 10.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_EU-Dispute-Form_CZ_Czech_Public | 10.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_Participant-Dosing-Diary_CZ_Czech_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-497-6486_Patient-Card_CZ_Czech_Public | 1.1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2022-501523-24-00_redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2022-501523-24-00_redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2022-501523-24-00_redacted | 2 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-09 | Germany | Acceptable 2023-09-22
|
2023-09-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-02 | Germany | Acceptable 2023-10-31
|
2023-11-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-26 | 2024-05-13 | ||
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-22 | Germany | 2024-05-22 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-01 | Germany | Acceptable | 2024-08-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-13 | Acceptable | 2024-09-20 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-13 | Acceptable | 2024-10-11 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-29 | Germany | Acceptable 2025-07-03
|
2025-07-07 |