Systemic Lupus ErythematosusPhase 1/2NCT05638802
A Study of DS-7011a in Patients With Systemic Lupus Erythematosus
A Phase 1/2 study testing DS-7011a in people with Systemic Lupus Erythematosus, run by Daiichi Sankyo at 20 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- DS-7011a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 7 Jun 2023to 1 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 18Show fewer
- 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).
- 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
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States12 sites
Pinnacle Research Group LLC
Anniston, Alabama, 36207
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
Joint & Muscle Research Institute
Charlotte, North Carolina, 28204
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034
Metroplex Clinical Research Center, LLC
Dallas, Texas, 75231
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Trinity Health Center Medical Arts
Minot, North Dakota, 58701
Arkansas Research Trials
North Little Rock, Arkansas, 72117
Office of Tory P. Sullivan, M.D. - North Miami Beach
North Miami Beach, Florida, 33162
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
West Broward Rheumatology Associates
Tamarac, Florida, 33321
Revival Research Institute, LLC
Troy, Michigan, 48084
Japan5 sites
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, 807-8556
Japan Community Health Care Organization Chukyo Hospital
Nagoya, 457-8510
Tohoku University Hospital
Sendai, 980-8574
Jcho Tokyo Yamate Medical Center
Shinjuku-ku, 169-0073
Yokohama City University Medical Center
Yokohama, 232-0024
China2 sites
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, 200001
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
North Macedonia1 site
Phi University Clinic of Rheumatology Skopje
Skopje, 1000
About this study
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
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- DS-7011a, Placebo
- Keywords
- Systemic Lupus Erythematosus, DS-7011a
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-7011aDrug
20 mg/kg intravenous dose to be administered every 4 weeks at baseline (Day 1), Day 29, and Day 57
PlaceboDrug
Saline intravenous solution administered every 4 weeks at baseline (Day 1), Day 29, and Day 57
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events Following Administration With DS-7011a in Participants With Systemic Lupus Erythematosus
TEAEs are defined as new AEs that occur after the first dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
Measured: Post first dose up to Week 24
Secondary outcomes (12)
Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Area under plasma concentration-time curve up to Day 28 was assessed by non-linear mixed-effect modeling.
Measured: AUC assessed up to 28 days after each dose on Day 1 (first dose), Day 29 (second dose), and Day 57 (third dose) end of infusion
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Maximum concentration was assessed by non-linear mixed-effect modeling.
Measured: Day 1 (first dose), Day 29 (second dose), and Day 57 (third dose) end of infusion
Pharmacokinetic Parameter Minimum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Minimum concentration was assessed by non-linear mixed-effect modeling.
Measured: Day 1 (first dose), Day 29 (second dose), and Day 57 (third dose) end of infusion
Change From Baseline in Cutaneous Lupus Area and Severity Index Activity Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Measurement scores for each area are assigned based on the most severe lesion within the area of interest. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. The change from baseline is being reported with greater negative index activity scores indicating clinical improvement.
Measured: Baseline (Day 1) 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
Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) is a five-point score that defines the level of disease severity based on overall lesion characteristics where 0 is "clear" and "4" is severe. The change from baseline is being reported with greater negative scores indicating clinical improvement.
Measured: Baseline (Day 1) up to Week 16
Change From Baseline in SLE Disease Activity Index 2000 Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Each symptom presented is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). The change from baseline is being reported with greater negative activity scores indicating clinical improvement.
Measured: Baseline (Day 1) up to Week 16
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
CGI-C is a brief rating scale that reflects the clinician's evaluation on the changes in systemic lupus erythematosus disease severity rated at each visit based on the clinician's judgment as "Very Much Worse", "Much Worse", "Minimally Worse", "No Change", "Minimally Improved", "Much Improved", "Very Much Improved".
Measured: Baseline (Day 1) up to Week 16
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
PGI-C is a self-rated scale that ask respondents to describe the retrospective change in their lupus skin symptoms at a given time point based on a 7-point scale as "Very Much Worse", "Much Worse", "Minimally Worse", "No Change", "Minimally Improved", "Much Improved", "Very Much Improved".
Measured: Baseline (Day 1) up to Week 16
Change From Baseline in Autoantibodies, Anti-Nuclear, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Autoantibodies, including antinuclear, were assessed.
Measured: Baseline (Day 1) up to Week 16
Change From Baseline in Autoantibodies, Anti-dsDNA, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Autoantibodies, including anti-dsDNA, were assessed.
Measured: Baseline (Day 1) up to Week 16
Change From Baseline in Autoantibodies, Anti-Smith and Anti-Ribonucleoprotein, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Autoantibodies, including anti-Smith [Sm], and antiribonucleoprotein [RNP] antibodies, were assessed.
Measured: Baseline (Day 1) up to Week 16
Change From Baseline in Complement Factors Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Complement factors, such as C3 and C4, will be assessed.
Measured: Baseline (Day 1) up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start7 Jun 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638802
- Sponsor's protocol ID
- DS7011-107
- Status last verified
- May 2026
- First submitted
- 28 Nov 2022
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05638802
- Acronym / sponsor ID
- DS7011-107
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, DS-7011a
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Posted 28 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS-7011a | Experimental | Drug: DS-7011aParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who will be randomized to receive placebo every 4 weeks by intravenous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS-7011a20 mg/kg intravenous dose to be administered every 4 weeks at baseline (Day 1), Day 29, and Day 57 | Drug | DS-7011a |
| PlaceboSaline intravenous solution administered every 4 weeks at baseline (Day 1), Day 29, and Day 57 | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events Following Administration With DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Post first dose up to Week 24
TEAEs are defined as new AEs that occur after the first dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
12 secondary outcomes
Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: AUC assessed up to 28 days after each dose on Day 1 (first dose), Day 29 (second dose), and Day 57 (third dose) end of infusion
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Day 1 (first dose), Day 29 (second dose), and Day 57 (third dose) end of infusion
Pharmacokinetic Parameter Minimum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Day 1 (first dose), Day 29 (second dose), and Day 57 (third dose) end of infusion
Change From Baseline in Cutaneous Lupus Area and Severity Index Activity Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Baseline (Day 1) 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
Time frame: Baseline (Day 1) up to Week 16
Change From Baseline in SLE Disease Activity Index 2000 Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Baseline (Day 1) up to Week 16
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Baseline (Day 1) up to Week 16
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Baseline (Day 1) up to Week 16
Change From Baseline in Autoantibodies, Anti-Nuclear, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Baseline (Day 1) up to Week 16
Change From Baseline in Autoantibodies, Anti-dsDNA, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Baseline (Day 1) up to Week 16
Change From Baseline in Autoantibodies, Anti-Smith and Anti-Ribonucleoprotein, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Baseline (Day 1) up to Week 16
Change From Baseline in Complement Factors Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Time frame: Baseline (Day 1) up to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DS-7011a in people with Systemic Lupus Erythematosus, run by Daiichi Sankyo at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Japan, China, North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events Following Administration With DS-7011a in Participants With Systemic Lupus Erythematosus (time frame: Post first dose up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.