LYNX: Study of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)

Sponsor

Gilead Sciences (Industry)

Overall Status

Suspended

CT.gov ID

NCT04809623

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

2.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of GS-5718 in participants with Cutaneous Lupus Erythematosus (CLE) with or without Systemic Lupus Erythematosus (SLE).

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Lupus Erythematosus	Drug: GS-5718 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Blinded, Placebo-Controlled, Phase 1b Study of GS-5718 in Subjects With Cutaneous Lupus Erythematosus (CLE)

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GS-5718 Participants will receive GS-5718 orally once daily for 4 weeks	Drug: GS-5718 Tablets administered orally
Experimental: Placebo Participants will receive placebo orally once daily for 4 weeks	Drug: Placebo Placebo to match GS-5718 tablets administered orally

Arm

Intervention/Treatment

Experimental: GS-5718

Participants will receive GS-5718 orally once daily for 4 weeks

Drug: GS-5718

Tablets administered orally

Experimental: Placebo

Participants will receive placebo orally once daily for 4 weeks

Drug: Placebo

Placebo to match GS-5718 tablets administered orally

Outcome Measures

Primary Outcome Measures

Percentage of Participants Experiencing Adverse Events [First dose date up to 4 weeks plus 28 days]
Percentage of Participants Experiencing Laboratory Abnormalities [First dose date up to 4 weeks plus 28 days]

Secondary Outcome Measures

Pharmacokinetic (PK) Parameter AUCtau of GS-5718 [Predose and up to 6 hours postdose at Week 4]
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Pharmacokinetic (PK) Parameter: Cmax of GS-5718 [Predose and up to 6 hours postdose at Week 4]
Cmax is defined as the maximum observed concentration of drug.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Either fulfill Image result for eular medical abbreviation The European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for SLE or have biopsy-proven CLE
Must have active acute cutaneous lupus erythematosus (ACLE)/ subacute cutaneous lupus erythematosus (SCLE); individuals with mixed skin presentations of lupus skin disease (including DLE) are allowed to enter
Cutaneous LE Disease Area and Severity Index (CLASI) activity score of ≥ 6 during screening and Day 1, excluding the alopecia component
Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and willingness to undergo skin biopsy at 2 time points
Protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents for the treatment of CLE/SLE (eg, antimalarials, methotrexate (MTX), or other conventional synthetic disease-modifying antirheumatic drug (csDMARDs)) must maintain stable dose(s) for ≥ 60 days prior to randomization through Week 4 of the study

Key Exclusion Criteria:

Dermatologic disease other than cutaneous manifestations of SLE or CLE that may interfere with assessment of lupus-specific skin lesions
Ongoing or active clinically significant bacterial, fungal or viral infection
History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
Uncontrolled health conditions including highly active SLE (e.g. lupus nephritis, neuropsychiatric SLE, vasculitis etc.)
History of malignancy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wallace Rheumatic Studies Center, LLC	Beverly Hills	California	United States	90211
2	Clinical Research of West Florida, Inc.	Clearwater	Florida	United States	33765
3	Dawes Fretzin Clincial Research Group, LLC	Indianapolis	Indiana	United States	46250
4	DJL Clinical Research, PLLC	Charlotte	North Carolina	United States	28210
5	Metroplex Clinical Research Center	Dallas	Texas	United States	75231

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Gilead Clinical Trials Website

Publications

None provided.

Responsible Party:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT04809623

Other Study ID Numbers:

GS-US-497-5888
2021-000204-38

First Posted:

Mar 22, 2021

Last Update Posted:

Aug 9, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

Lupus Erythematosus, Cutaneous

Study Results

No Results Posted as of Aug 9, 2022