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A Study of DS-7011a in Patients With Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of DS-7011a in Patients With Systemic Lupus Erythematosus

A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore the Safety, Pharmacokinetics, and Proof of Biological Activity of DS-7011a in Patients With Systemic Lupus Erythematosus

NCT05638802•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized by autoantibody production, inflammation, and tissue damage in multiple organs. Standard of care therapies used to treat SLE are only partially effective and have a wide range of toxicities. There is a need for more effective and safer therapies for patients with SLE.

Detailed Description

This Phase 1b/2 study will initially explore the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of DS-7011a in patients with SLE. DS-7011a is an anti-Toll-like receptor 7 (TLR7) antagonistic monoclonal antibody developed for the treatment of SLE.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female participants must be of 18 years or more with definite SLE for at least 6 months prior to Screening, defined according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, including documented history of positivity for antinuclear antibody (titer ≥1:80).
•Body mass index (BMI) ≥18 kg/m\^2 and body weight ≥45 kg.
•Presence of active CLE (acute, subacute, and chronic cutaneous lupus), with active skin involvement and a CLASI-A score of 4 or higher at the time of screening and randomization as recognized by 2 adjudicators, ie, the investigator in the periphery at the site and a centrally located arbiter contracted ad hoc (in case of disagreement between these 2 adjudicators, a third adjudicator, also centrally located and contracted ad hoc, will solve the disagreement and provide a final decision), despite adequate use of conventional therapies (either topical corticosteroids or antimalarial agents used for at least 12 weeks prior to Screening) or because of the requirement to discontinue these therapies due to side effects or poor tolerability.
•Participants must be willing to have skin tape harvests collected from the affected skin area (skin tape stripping done on the target lesion).
•Participants must agree not to participate in any other investigational study during the study Treatment Period and for 3 months after the last dose of study drug.
•Participants must give written informed consent to participation in the study prior to Screening.
•Participants must be vaccinated against COVID-19

Exclusion Criteria

•Active lupus nephritis (LN) on induction therapy, or induction therapy completed within 12 weeks prior to Screening (stable maintenance therapy with mycophenolate or azathioprine allowed).
•Active neuropsychiatric SLE, including, but not limited to, the following: seizure, new or worsening impaired level of consciousness, psychosis, delirium or confusional state, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, mononeuritis multiplex, or demyelinating syndromes.
•Primary diagnosis of autoimmune or rheumatic disease other than SLE (secondary Sjögren's syndrome or autoimmune thyroiditis are not exclusionary) or drug-induced lupus.
•History of chronic, recurrent (3 or more of the same type of infection in 1 year) or recent serious infection, including viral infections, as determined by the investigator, or requiring anti-infective treatment within 12 weeks prior to Screening.
•History of severe herpes infection or signs of herpes or varicella zoster viral infection within 12 weeks prior to Screening.
•Positive COVID-19 molecular test at Screening or symptoms suggestive of SARS-CoV-2 infection or close contact with an individual with SARS-CoV-2 infection within 2 weeks prior to randomization.
•History of malignant disease within the 2 years before Screening or ongoing at the time of Screening, except basal cell carcinomas and squamous cell carcinomas of the skin, or completely excised carcinoma in situ of the cervix
•Chronic kidney disease with significant proteinuria (ie, \>2 g/24 h or urine protein to creatinine ratio \>200 mg/g) or decreased renal function (estimated glomerular filtration rate \[eGFR\] \<30 mL/min).
•New York Heart Association class III or IV congestive heart failure.
•Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study.
+8 more criteria

Locations (12)

Pinnacle Research Group LLC

Anniston, Alabama, United States

Arkansas Research Trials

North Little Rock, Arkansas, United States

Office of Tory P. Sullivan, M.D. - North Miami Beach

North Miami Beach, Florida, United States

West Broward Rheumatology Associates

Tamarac, Florida, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

Revival Research Institute, LLC

Troy, Michigan, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Joint & Muscle Research Institute

Charlotte, North Carolina, United States

Trinity Health Center Medical Arts

Minot, North Dakota, United States

Key Dates

Start Date

June 7, 2023

Primary Completion Date

April 1, 2025

Completion Date

April 1, 2025

Last Updated

April 4, 2025

Enrollment

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

DS-7011a

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of DS-7011a in Patients With Systemic Lupus Erythematosus

Inclusion Criteria

Exclusion Criteria

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