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Study Summary
This trial tests a drug to treat a chronic autoimmune disease, lupus, which has few safe & effective therapies.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.I am currently on or recently finished lupus nephritis treatment.I have had frequent or serious infections needing treatment in the last 3 months.I am vaccinated against COVID-19.I have an active hepatitis C infection confirmed by a test.I am willing to have skin samples taken from my affected area.I have an autoimmune disease that is not lupus, except for Sjögren's syndrome or autoimmune thyroiditis.I have active brain or nerve-related symptoms due to my lupus.I haven't had cancer, except for certain skin cancers or treated cervical cancer, in the last 2 years.I do not have a skin condition that could affect the study's skin assessments.I am 18 or older with SLE diagnosed for at least 6 months and have a positive ANA test.I have kidney disease with high protein in my urine or low kidney function.I have never had, nor currently have, active or untreated latent tuberculosis.I have not had a severe herpes or shingles infection in the last 3 months.I have used steroids for more than 2 weeks in the last 6 months for a condition other than lupus.I have active skin lupus with a CLASI-A score of 4 or more.
- Group 1: DS-7011a
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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