DS-7011a for Lupus

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

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing DS-7011a, a new medicine for patients with lupus. It aims to see if it is safe and effective by blocking part of the immune system to reduce inflammation and organ damage.

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.

Research Team

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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