DS-7011a for Lupus

No longer recruiting at 11 trial locations

Overseen By Contact for Clinical Trial Information Disclosure

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Daiichi Sankyo

Must be taking: Topical corticosteroids, Antimalarials

Disqualifiers: Lupus nephritis, Neuropsychiatric SLE, Infections, Cancer, others

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DS-7011a for people with systemic lupus erythematosus (SLE), a chronic autoimmune disease causing inflammation and tissue damage. Current SLE treatments often lack effectiveness and can cause serious side effects, so the trial seeks a safer and more effective option. Participants will receive either the experimental drug or a placebo (a harmless substance with no treatment effect) through an IV every four weeks. The trial seeks individuals who have had SLE for at least six months and are experiencing active skin symptoms despite using typical treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on induction therapy for lupus nephritis and should not have taken certain anti-infective treatments recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that DS-7011a is likely to be safe for humans?

Research has shown that DS-7011a is safe. In an initial human study, DS-7011a was well-tolerated, with no major safety issues. The study also examined how the body processed the drug, and the results support further testing for treating systemic lupus erythematosus (SLE). Although more research is needed, these early findings are promising for those considering participation in a clinical trial for DS-7011a. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lupus, which often include corticosteroids and immunosuppressants, DS-7011a is designed to be administered by intravenous infusion every four weeks, potentially offering a more convenient dosing schedule. Most treatments for lupus work by broadly suppressing the immune system. However, DS-7011a targets specific pathways involved in the inflammation process, which could mean fewer side effects and a more precise approach to managing lupus symptoms. Researchers are excited about DS-7011a because it represents a novel mechanism of action that could improve the quality of life for patients with systemic and cutaneous lupus.

What evidence suggests that DS-7011a might be an effective treatment for lupus?

Research has shown that DS-7011a, which participants in this trial may receive, targets TLR7, a protein involved in the immune system. In lab tests, it lowers levels of harmful substances called cytokines and antibodies, often elevated in people with lupus. Early studies suggest that DS-7011a is safe and effective, making it a promising treatment for systemic lupus erythematosus (SLE). Although researchers are still studying DS-7011a, its mechanism suggests it might offer a better and safer option for SLE than current treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Are You a Good Fit for This Trial?

Adults over 18 with confirmed systemic lupus erythematosus (SLE) for at least 6 months, who have active skin symptoms despite treatment, and a BMI of 18-40. Participants must be COVID-19 vaccinated and agree to not join other studies during this one. Exclusions include severe herpes infection history, other conditions that could affect the study or pose risks, certain infections within the last 12 weeks, active neuropsychiatric SLE, recent serious infections or lupus nephritis treatments.

Inclusion Criteria

Body mass index (BMI) ≥18 kg/m^2 and body weight ≥45 kg

I am vaccinated against COVID-19.

Participants must give written informed consent to participation in the study prior to Screening

Exclusion Criteria

I have severe heart failure.

I have an active hepatitis B infection.

I have tested positive for COVID-19 or have symptoms/had close contact with someone infected recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DS-7011a or placebo every 4 weeks by intravenous infusion

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DS-7011a

Trial Overview The trial is testing DS-7011a against a placebo in patients with SLE and cutaneous lupus erythematosus. It aims to find a safer and more effective treatment than current options by comparing improvements between those taking the actual drug versus those on a placebo.

How Is the Trial Designed?

Group I: DS-7011a Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Daiichi Sankyo, Inc.

Lead Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05638802

A Study of DS-7011a in Patients With Systemic Lupus ... This Phase 1b/2 study will initially explore the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of DS-7011a in patients ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724163212

L. DS-7011a is an anti-TLR7 monoclonal antibody, which inhibits in vitro production of cytokines and antibodies stimulated by TLR7. A surrogate anti-TLR7 mAb ...

3. ard.bmj.com ard.bmj.com/content/annrheumdis/83/Suppl_1/953.full.pdf

Scientific Abstracts 963 DS-7011a is an anti-. TLR7 monoclonal antibody, which inhibits in vitro production of cytokines and antibodies stimulated by TLR7. A surrogate ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39169827/

First-in-Human Study of the Safety, Tolerability ... DS-7011a showed favorable safety, pharmacokinetics, immunogenicity, and PD properties that support its development for the treatment of SLE.

5. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.6117

First‐in‐Human Study of the Safety, Tolerability ... DS-7011a showed favorable safety, pharmacokinetics, immunogenicity, and PD properties that support its development for the treatment of SLE.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05203692

A Study of a Single Ascending Dose Study of DS-7011a in ... This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in ...