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

NCT05638802 | Completed Phase 1 FDA Drug

• 1 other identifier: DS7011-107
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; DS-7011a

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Participants With Systemic Lupus Erythematosus

  Screening up to Week 24

Secondary Outcomes (10)

• Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

  Day 1 (at predose and at end of infusion), Day 2 (24 hours after administration), Day 8 (1 week after administration), Days 29 and 57 (at predose and at end of infusion), and Days 85 and 113

• Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

  Day 1 (at predose and at end of infusion), Day 2 (24 hours after administration), Day 8 (1 week after administration), Days 29 and 57 (at predose and at end of infusion), and Days 85 and 113

• Pharmacokinetic Parameter Minimum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

  Day 1 (at predose and at end of infusion), Day 2 (24 hours after administration), Day 8 (1 week after administration), Days 29 and 57 (at predose and at end of infusion), and Days 85 and 113

• Change From Baseline in Cutaneous Lupus Area and Severity Index Activity Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

  Screening up to Week 16

• Change From Baseline in Cutaneous Lupus Activity Investigator Global Assessment Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

  Screening up to Week 16

Study Arms (2)

DS-7011a

EXPERIMENTAL

Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who will be randomized to receive DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.

Drug: DS-7011a

Placebo

PLACEBO COMPARATOR

Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who will be randomized to receive placebo every 4 weeks by intravenous infusion.

Drug: Placebo

Interventions

DS-7011a DRUG

20 mg/kg intravenous dose to be administered every 4 weeks at baseline (Day 1), Day 29, and Day 57

DS-7011a

Placebo DRUG

Saline intravenous solution administered every 4 weeks at baseline (Day 1), Day 29, and Day 57

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• History or positive test result for human immunodeficiency virus at Screening.
• Active hepatitis B virus (HBV) infection determined at Screening as positive test result for hepatitis B surface antigen.
• Active hepatitis C virus (HCV) infection determined at Screening as HCV ribonucleic acid (RNA) above the limit of detection in subjects with positive HCV antibody titer.
• History of, or ongoing, active tuberculosis (TB) or untreated latent TB infection (LTBI) at Screening. Participants with documented previously completed appropriate LTBI treatment and without evidence of re-exposure will not be required to be tested.
• Any other significant condition that according to the investigator's judgment would prevent compliance with study protocol and full study participation.
• Participants must not be participating in another investigational study or have participated in an investigational study within the past 30 days prior to randomization (Day 1).

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (12)

Pinnacle Research Group LLC

Anniston, Alabama, 36207, United States

Location

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

Location

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

North Miami Beach, Florida, 33162, United States

Location

West Broward Rheumatology Associates

Tamarac, Florida, 33321, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Joint & Muscle Research Institute

Charlotte, North Carolina, 28204, United States

Location

Trinity Health Center Medical Arts

Minot, North Dakota, 58701, United States

Location

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034, United States

Location

Metroplex Clinical Research Center, LLC

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 6, 2022
• Study Start: June 7, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (12)