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Monoclonal Antibodies

DS-7011a for Lupus

Phase 1 & 2

Recruiting

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial tests a drug to treat a chronic autoimmune disease, lupus, which has few safe & effective therapies.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of DS-7011a are not listed here, clinical trials typically monitor for any adverse reactions ranging from mild (like headaches or nausea) to severe (such as allergic reactions or organ inflammation). Patients will be closely observed for any such effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change From Baseline in Autoantibodies Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

Change From Baseline in Complement Factors Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DS-7011aExperimental Treatment1 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: PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DS-7011a

2022

Completed Phase 1

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor

393 Previous Clinical Trials

416,277 Total Patients Enrolled

Daiichi Sankyo, Inc.Lead Sponsor

389 Previous Clinical Trials

420,134 Total Patients Enrolled

Global Clinical LeaderStudy DirectorDaiichi Sankyo

162 Previous Clinical Trials

79,114 Total Patients Enrolled

Media Library

DS-7011a (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05638802 — Phase 1 & 2

Lupus Research Study Groups: DS-7011a, Placebo

Lupus Clinical Trial 2023: DS-7011a Highlights & Side Effects. Trial Name: NCT05638802 — Phase 1 & 2

DS-7011a (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05638802 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participants in this clinical trial?

"The clinical trial, which was initially announced on June 7th 2023, is still actively recruiting. Clinicaltrials.gov recently updated their records as of July 10th 2023 for this study."

Answered by AI

How many individuals have been included in this research endeavor?

"To successfully complete this research, 24 applicants who meet the outlined inclusion criteria must join. Potential participants can sign up for the study at Arkansas Research Trials in North Little Rock or Office of Tory P. Sullivan, M.D.- North Miami Beach located in Florida's North Miami Beach area."

Answered by AI

How many healthcare institutions are actively engaged in this research trial?

"Patients can enrol in this research study at Arkansas Research Trials (North Little Rock), Office of Tory P. Sullivan, M.D. - North Miami Beach (Florida), and West Broward Rheumatology Associates (Tamarac) as well as 11 other centres spread throughout the country."

Answered by AI