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

Primary Purpose

Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DS-7011a
Placebo
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, DS-7011a

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 to 40 kg/m^2 inclusive 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 adjudicated by 2 dermatologists, 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 and boosted against COVID-19, i.e., must have received all recommended primary vaccination doses and at least one booster dose, if eligible. 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, or ongoing, malignant disease except basal cell carcinomas and squamous cell carcinomas of the skin or carcinoma in situ of the cervix completely excised and considered cured for at least 2 years prior to Screening. Chronic kidney disease with significant proteinuria (ie, >2 g/24 h or urine protein to creatinine ratio >2) or decreased renal function (estimated glomerular filtration rate [eGFR] <30). 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 infection determined as positive test result for hepatitis B surface antigen at Screening. Active hepatitis C virus (HCV) infection determined as HCV ribonucleic acid (RNA) above the limit of detection in subjects with positive HCV antibody titer, at Screening. 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). History of or current inflammatory skin disease other than SLE that in the opinion of the investigator could interfere with the inflammatory skin assessments and confound the disease activity assessments. History of any non-SLE disease that had required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to randomization.

Sites / Locations

  • Pinnacle Research Group LLCRecruiting
  • Arkansas Research TrialsRecruiting
  • Office of Tory P. Sullivan, M.D. - North Miami BeachRecruiting
  • West Broward Rheumatology AssociatesRecruiting
  • The University of Kansas Medical CenterRecruiting
  • Oakland Hills DermatologyRecruiting
  • Revival Research Institute, LLCRecruiting
  • MediSearch Clinical TrialsRecruiting
  • Joint & Muscle Research InstituteRecruiting
  • Precision Comprehensive Clinical Research SolutionsRecruiting
  • Metroplex Clinical Research Center, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DS-7011a

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematous
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematous
Pharmacokinetic Parameter Minimum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus
Change From Baseline in Cutaneous Lupus Area and Severity Index Activity Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Change From Baseline in Cutaneous Lupus Activity Investigator Global Assessment Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Change From Baseline in SLE Disease Activity Index 2000 Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Change From Baseline in Autoantibodies Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Autoantibodies, including antinuclear, anti-dsDNA, anti-Smith [Sm], and antiribonucleoprotein [RNP] antibodies, will be assessed.
Change From Baseline in Complement Factors Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Complement factors, such as C3 and C4, will be assessed.

Full Information

First Posted
November 28, 2022
Last Updated
July 10, 2023
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05638802
Brief Title
A Study of DS-7011a in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Official Title
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 and Active Cutaneous Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 and active cutaneous lupus erythematosus (CLE). DS-7011a is an anti-Toll-like receptor 7 (TLR7) antagonistic monoclonal antibody developed for the treatment of SLE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, DS-7011a

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DS-7011a
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who will be randomized to receive placebo every 4 weeks by intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
DS-7011a
Intervention Description
20 mg/kg intravenous dose to be administered every 4 weeks at baseline (Day 1), Day 29, and Day 57
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline intravenous solution administered every 4 weeks at baseline (Day 1), Day 29, and Day 57
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Time Frame
Screening up to Week 24
Secondary Outcome Measure Information:
Title
Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematous
Time Frame
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
Title
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematous
Time Frame
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
Title
Pharmacokinetic Parameter Minimum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus
Time Frame
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
Title
Change From Baseline in Cutaneous Lupus Area and Severity Index Activity Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Time Frame
Screening up to Week 16
Title
Change From Baseline in Cutaneous Lupus Activity Investigator Global Assessment Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Time Frame
Screening up to Week 16
Title
Change From Baseline in SLE Disease Activity Index 2000 Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Time Frame
Screening up to Week 16
Title
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Time Frame
Screening up to Week 16
Title
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Time Frame
Screening up to Week 16
Title
Change From Baseline in Autoantibodies Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Description
Autoantibodies, including antinuclear, anti-dsDNA, anti-Smith [Sm], and antiribonucleoprotein [RNP] antibodies, will be assessed.
Time Frame
Screening up to Week 16
Title
Change From Baseline in Complement Factors Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Description
Complement factors, such as C3 and C4, will be assessed.
Time Frame
Screening up to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 to 40 kg/m^2 inclusive 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 adjudicated by 2 dermatologists, 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 and boosted against COVID-19, i.e., must have received all recommended primary vaccination doses and at least one booster dose, if eligible. 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, or ongoing, malignant disease except basal cell carcinomas and squamous cell carcinomas of the skin or carcinoma in situ of the cervix completely excised and considered cured for at least 2 years prior to Screening. Chronic kidney disease with significant proteinuria (ie, >2 g/24 h or urine protein to creatinine ratio >2) or decreased renal function (estimated glomerular filtration rate [eGFR] <30). 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 infection determined as positive test result for hepatitis B surface antigen at Screening. Active hepatitis C virus (HCV) infection determined as HCV ribonucleic acid (RNA) above the limit of detection in subjects with positive HCV antibody titer, at Screening. 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). History of or current inflammatory skin disease other than SLE that in the opinion of the investigator could interfere with the inflammatory skin assessments and confound the disease activity assessments. History of any non-SLE disease that had required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Contact for Clinical Trial Information Disclosure
Phone
908-992-6400
Email
CTRinfo@dsi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Arkansas Research Trials
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Office of Tory P. Sullivan, M.D. - North Miami Beach
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Manager
Facility Name
West Broward Rheumatology Associates
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Oakland Hills Dermatology
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Revival Research Institute, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruitment Coordinator
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Joint & Muscle Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Metroplex Clinical Research Center, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

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

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