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

Primary Purpose

Cutaneous Lupus Erythematosus

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Edecesertib

Placebo

About this trial

This is an interventional treatment trial for Cutaneous Lupus Erythematosus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Wallace Rheumatic Studies Center, LLC
Clinical Research of West Florida, Inc.
Dawes Fretzin Clincial Research Group, LLC
DJL Clinical Research, PLLC
Metroplex Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Edecesertib

Placebo

Arm Description

Participants will receive edecesertib orally once daily for 4 weeks

Participants will receive placebo orally once daily for 4 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants Experiencing Adverse Events

Percentage of Participants Experiencing Laboratory Abnormalities

Secondary Outcome Measures

Pharmacokinetic (PK) Parameter AUCtau of Edecesertib

AUCtau is defined as the area under the concentration versus time curve over the dosing interval.

Pharmacokinetic (PK) Parameter: Cmax of Edecesertib

Cmax is defined as the maximum observed concentration of drug.

Full Information

NCT ID

NCT04809623

First Posted

March 18, 2021

Last Updated

May 1, 2023

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04809623

Brief Title

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

Acronym

LYNX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision to terminate study.

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

October 18, 2022 (Actual)

Study Completion Date

October 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Edecesertib

Arm Type

Experimental

Arm Description

Participants will receive edecesertib orally once daily for 4 weeks

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Participants will receive placebo orally once daily for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Edecesertib

Other Intervention Name(s)

GS-5718

Intervention Description

Tablets administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to match edecesertib tablets administered orally

Primary Outcome Measure Information:

Title

Percentage of Participants Experiencing Adverse Events

Time Frame

First dose date up to 4 weeks plus 28 days

Title

Percentage of Participants Experiencing Laboratory Abnormalities

Time Frame

First dose date up to 4 weeks plus 28 days

Secondary Outcome Measure Information:

Title

Pharmacokinetic (PK) Parameter AUCtau of Edecesertib

Description

AUCtau is defined as the area under the concentration versus time curve over the dosing interval.

Time Frame

Predose and up to 6 hours postdose at Week 4

Title

Pharmacokinetic (PK) Parameter: Cmax of Edecesertib

Description

Cmax is defined as the maximum observed concentration of drug.

Time Frame

Predose and up to 6 hours postdose at Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Wallace Rheumatic Studies Center, LLC

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Clinical Research of West Florida, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Dawes Fretzin Clincial Research Group, LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46250

Country

United States

Facility Name

DJL Clinical Research, PLLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.gileadclinicaltrials.com/study/?id=GS-US-497-5888

Description

Gilead Clinical Trials Website

Learn more about this trial

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

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