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Systemic Lupus ErythematosusPhase 2DARALUPNCT04810754

An Open Label Study to Evaluate Daratumumab in Participants With Moderate to Severe Systemic Lupus Erythematosus

A Phase 2 study testing Daratumumab Injection in people with Systemic Lupus Erythematosus, run by Charite University, Berlin, Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a monocenter, open-label Phase II trial for refractory SLE patients currently on stable background immunosuppressive therapy. Treatment in this trial will be daratumumab weekly for a period of 8 weeks. This study will enroll 10 patients. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Daratumumab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
30 Jun 2021to 31 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • diagnosis of SLE according to the 2019 EULAR/ACR Systemic Lupus Erythematosus classification criteria.
  • age between 18 and 60 years, inclusive, at consent.
  • have a body mass index (BMI) between 18 and 32 kg/m² (BMI = weight/height2), inclusive, and a body weight of no less than 35 kg.
  • demonstrate moderate to severe disease based on SLEDAI-2K score ≥ 6 observed at screening
  • SLEDAI-2K ≥ 4 for clinical features (i.e. SLEDAI excluding laboratory results) at screening
  • have a positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) test, as measured by enzyme-linked immunosorbent assay (ELISA) test.
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  • Failure or lack of tolerability of at least 2 previous state-of-the-art immunosuppressive drugs/immunomodulatory drugs including antimalarials (does not account for glucocorticoids).
  • if using oral corticosteroids, must be receiving this medication for at least 4 weeks and on a stable dose equivalent to an average dose of <20 mg of prednisone daily for at least 4 weeks prior to the first dose of study agent.
  • if using immunosuppressive drugs within the past 6 months, must not have exceeded the following dose levels: methotrexate 25 mg/week, azathioprine 2mg/kg/day, mycophenolate mofetil (MMF) 3g/day, or mycophenolic acid (MPA) 1440mg/day.
  • if using immunosuppressive drugs, must be using not more than 1 immunosuppressive drug (does not account for antimalarials and glucocorticoids) and not have used any additional immunosuppressive drug within the past 3 months prior to the first dose of study agent.

Who cannot join

  • has any unstable or progressive manifestation of SLE (lupus cerebritis, optic neuritis, transverse myelitis, psychosis, uncontrolled seizures, systemic vasculitis, end-stage renal disease, rapidly progressive Class III or IV glomerulonephritis, isolated Class V lupus nephritis [i.e. without coexistent Class I, II, III, or IV nephritis], Class VI lupus nephritis, pulmonary hemorrhage, myocarditis) that is likely to warrant escalation in therapy beyond permitted background medications. Subjects requiring renal hemodialysis or peritoneal dialysis are also excluded.
  • has or has had a history of any clinically significant medical illness, or medical disorders the investigator considers significant should exclude the participant, including (but not limited to), hematological disease, immune deficiency states, respiratory disease, cardiovascular disease (including poor peripheral venous access), hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
  • has or has had a serious infection (e.g. sepsis, pneumonia, or pyelonephritis), or been hospitalized or received IV antibiotics for a serious infection during the 3 months prior to consent.
  • had major surgery, (e.g. requiring general anesthesia) within 3 months before screening.
  • has or has had an acute illness, including a common cold, within 2 weeks prior to first study treatment or has had a major illness or hospitalization within 3 months prior to consent.
  • has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis.
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  • has received, is known to have received, or is suspected to have an intolerance or hypersensitivity (including delayed-type hypersensitivity) to any monoclonal antibodies or antibody fragments, is known to have allergies or clinically significant reactions to human proteins, monoclonal XML File Identifier: O1ANMGHPajQP16EY/porgcGYJv8= Page 11/23 antibodies, or antibody fragments, or to any components of the formulation used in this study, including daratumumab.
  • has received any live virus or bacterial vaccinations within 12 weeks prior to first study treatment or is expected to receive any live virus or bacterial vaccinations during the study or up to 20 weeks after last study treatment.
  • has received B cell depleting therapy within 12 months prior to first administration of the study agent (e.g. rituximab, ocrelizumab or obinutuzumab),
  • has received a therapy that inhibits B-cell activating factor (BAFF) (i.e. belimumab) within 3 months prior to first administration of the study agent.
  • has received prior experimental immunosuppressive biologic therapy for lupus (other than that described as allowed), less than 5 half-lives or 6 months, whichever is longer prior to first administration of the study agent.
  • has used oral or IV cyclophosphamide within 2 months prior to first administration of the study agent.
  • has ever been exposed to daratumumab or any anti-CD38 antibodies (e.g. TAK-079, MOR202, isatuximab).
  • has a history of, or ongoing, chronic or recurrent infection/diagnosed latent infection, including but not limited to, chronic renal infection, chronic chest infection (e.g. bronchiectasis), sinusitis, recurrent urinary tract infection (e.g. recurrent pyelonephritis), an open, draining, or infected skin wound, or an ulcer.
  • has or has had a serious infection (e.g. sepsis, pneumonia or pyelonephritis) or has been hospitalized or received IV antibiotics for a serious infection during the 3 months prior to consent.
  • Ongoing infection (requiring antibiotic treatment or fever > 38°C), including known HIV, active or chronic hepatitis B or hepatitis C.
  • has experienced a recent single dermatomal herpes zoster eruption within the past 6 months, or has a history of disseminated forms of zoster within the past 2 years prior to screening.
  • has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
  • has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.
  • have had an opportunistic infection (e.g. pneumocystis, aspergillosis, mycobacterium avium complex).
  • has a history of malignancy within 5 years before consent (squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence).
  • has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location, or history of monoclonal gammopathy of undetermined significance.

Trial locations and contacts

No sites are listed yet.

Tobias Alexander, MD contact

+4930450 ext. 513137

tobias.alexander@charite.de

Jan Zernicke, Dr.rer.medic contact

+4930450 ext. 513227

jan.zernicke@charite.de

About this study

Official title: A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus

This is a monocenter, open-label Phase II trial for refractory SLE patients currently on stable background immunosuppressive therapy. Treatment in this trial will be daratumumab weekly for a period of 8 weeks. This study will enroll 10 patients.

Read the detailed description

This clinical trial "DARALUP" is designed to evaluate the efficacy and safety of daratumumab, a monoclonal antibody directed against CD38, in patients with systemic lupus erythematosus (SLE). This is a monocenter, open-label Phase II trial recruting SLE patients with clinical and serologic activity despite state-of-the-art immunosuppressive therapy. Treatment in this study will be Weekly daratumumab injections over a period of 8 weeks. This study will enroll 10 patients.

SLE is a sometimes severe, generalized autoimmune disease with few approved therapies to date. Therefore, the planned study offers an opportunity to identify a new, targeted therapeutic approach. Daratumumab has been studied in multiple Phase III clinical trials in patients with relapsing multiple myeloma, a plasma cell malignancy, where it demonstrated efficacy with an acceptable safety profile and has been approved since 2016 under the trade name Darzalex®. The aim is to investigate whether daratumumab provides clinically significant efficacy in SLE, another disease in which plasma cells have been shown to play a pathogenic role. Previous experience by the sponsor of this trial with the use of daratumumab in two patients with SLE suggests that one cycle of 4 weekly infusions with 16 mg/kg daratumumab was associated with a significant serologic and clinical response. In this study, a dosing regimen of 2 cycles of Darzalex is planned, with one cycle containing 4 Weekly injections. Based on the previously reported efficacy under anti-CD38 therapy, this human monoclonal antibody appears suitable for the therapy of SLE and will be investigated in this study.

Being tested
Daratumumab Injection
Keywords
SLE, Daratumumab, anti-CD38, plasma cells, anti-dsDNA antibodies, lupus, CD38
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.

  • Daratumumab InjectionDrug

    Also called DARZALEX (trade name)

    1800 mg per injection; 8 consecutive injections once a week; subcutaneous application in abdomen

Study groups in NCT04810754
Study groupRoleWhat they receive
Daratumumab subcutaneousExperimentalopen label daratumumab s.c., unblinded
Receives: Drug: Daratumumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum anti-dsDNA antibody titers

    The primary endpoint is the significant reduction of serum anti-dsDNA antibody titers after 8 repeated weekly injections of daratumumab at Week 12, i.e. 4 weeks after the last daratumumab injection, compared to baseline

    Measured: Week 12 (i.e. 4 weeks after last daratumumab injection)

Secondary outcomes (6)

  1. Assess the Incidence of Treatment-Emergent Adverse Events

    Adverse Events will be as assessed and graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: through study completion, from screening up to Week 36

  2. Clinical outcome parameter

    Number of participants achieving Systemic Lupus Responder Index 4

    Measured: Week 12

  3. SLE serology

    Evaluating the change in serum complement factor C3 levels

    Measured: through study completion, up to Week 36

  4. GC sparing

    Investigating median change of daily prednisolone dosage

    Measured: between Week 12 and Week 36

  5. Health-related quality of life

    Patient related outcome measures will be investigated, overall health assessed by Short-Form 36 Score

    Measured: through study completion, up to Week 36

  6. Health-related quality of life

    Patient related outcome measures will be investigated, Fatigue assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score

    Measured: through study completion, up to Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start30 Jun 2021 (estimated)
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
open label, unblinded
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04810754
Sponsor's protocol ID
CCM-RNT-202101
Other IDs
2021-000962-14
Acronym
DARALUP
Status last verified
Mar 2021
First submitted
11 Mar 2021
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ostendorf L, Burns M, Durek P, Heinz GA, Heinrich F, Garantziotis P, Enghard P, Richter U, Biesen R, Schneider U, Knebel F, Burmester G, Radbruch A, Mei HE, Mashreghi MF, Hiepe F, Alexander T. Targeting CD38 with Daratumumab in Refractory Systemic Lupus Erythematosus. N Engl J Med. 2020 Sep 17;383(12):1149-1155. doi: 10.1056/NEJMoa2023325.

    PubMed 32937047

  • Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.

    PubMed 40465397

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab Injection in people with Systemic Lupus Erythematosus, run by Charite University, Berlin, Germany.

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 10 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tobias Alexander, MD (+4930450 ext. 513137, tobias.alexander@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum anti-dsDNA antibody titers (time frame: Week 12 (i.e. 4 weeks after last daratumumab injection)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04810754, which also lists 2 linked publications.

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 23 Mar 2021.

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