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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-10-18

Brief Summary

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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).

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Detailed Description

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Conditions

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Cutaneous Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Edecesertib

Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks.

Group Type EXPERIMENTAL

Edecesertib

Intervention Type DRUG

Tablets administered orally

Standard of Care

Intervention Type DRUG

Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone)

Placebo

Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo to match edecesertib tablets administered orally

Standard of Care

Intervention Type DRUG

Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone)

Interventions

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Edecesertib

Tablets administered orally

Intervention Type DRUG

Placebo

Placebo to match edecesertib tablets administered orally

Intervention Type DRUG

Standard of Care

Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone)

Intervention Type DRUG

Other Intervention Names

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GS-5718

Eligibility Criteria

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Inclusion Criteria

* Either fulfill the European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) or have biopsy-proven cutaneous lupus erythematosus (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.
* CLE 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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No