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Elsubrutinib + Upadacitinib for Lupus
Study Summary
This trial is evaluating the combination of elsubrutinib and upadacitinib for the treatment of Systemic Lupus Erythematosus (SLE). Elsubrutinib and upadacitinib will be given orally, once daily for up to 56 weeks. The study will assess the change in disease symptoms.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 242 Patients • NCT03682705Trial Design
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- You have a history of a hole in your stomach or intestine, or your doctor thinks you are at high risk for this happening.
- Group 1: Part 1: Elsubrutinib Dose A and Upadacitinib Dose A
- Group 2: Part 3: Elsubrutinib Dose A and Upadacitinib Placebo
- Group 3: Part 2: Elsubrutinib Dose A and Upadacitinib Dose B
- Group 4: Part 4: Elsubrutinib Placebo and Upadacitinib Dose A
- 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
Does the study allow those over 20 years of age to participate?
"For this medical study, eligibility requires participants to be under 65 and above legal age."
Is there an open call for participants in this experiment?
"As per the information on clinicaltrials.gov, this experiment is not presently accepting patients. It was initially advertised on July 27th 2020, but has been updated most recently November 9th 2022. At present there are 143 other trials recruiting participants across the country."
How might Elsubrutinib pose a risk for individuals?
"The safety of Elsubrutinib is relatively well-established, thus giving it a score of 2. This drug has been tested in Phase 2 trials and there are data points to support the assertion that it is secure for use but none yet verifying its efficacy."
How many individuals are being administered the experimental therapy in this clinical trial?
"At present, there is no recruitment for this medical trial. Initially posted on July 27th 2020 and last updated on November 9th 2022, the study has been suspended in its current incarnation. However, those seeking to contribute to clinical research can find 122 trials related lupus erythematosus systemic or 21 studies involving Elsubrutinib that are actively recruiting participants."
Is my profile compatible with the criteria for this clinical trial?
"This clinical trial seeks enrolment from 260 individuals aged 18 to 65 suffering from lupus erythematosus, systemic. The inclusion criteria requires participants have already taken part in Study M19-130 and their SLE must be stable during the study period. Additionally, they should not possess laboratory or clinical characteristics that would lead to discontinuation according to those previously established in the randomized control trail of elsubrutinib, upadacitinib and ABBV-599 combination or matching placebo."
To what extent have other researchers explored the effects of Elsubrutinib?
"Presently, there are 21 active clinical trials using Elsubrutinib; 14 of these studies have reached Phase 3. Multiple sites in Central Singapore are offering this medication to patients, but it is available at 3924 different locations globally."
What is the customary purpose of Elsubrutinib?
"Elsubrutinib is an appropriate systemic therapy for individuals living with rheumatoid arthritis, as well as those being treated with methotrexate."
How far-reaching is the distribution of this clinical experiment?
"The trial is accessible at 33 different sites, such as Qualmedica Research, LLC /ID# 227817 in Evansville, Allegheny Health Network Research Institute /ID# 245086 in Pittsburgh and St. Josephs Health Care Centre /ID# 221873 located in London."
Does this research offer an innovative approach to the topic?
"Elsubrutinib's clinical trials have been a global affair, with 54 countries and 953 cities hosting 21 live studies. The earliest trial for the drug was sponsored by AbbVie in 2015; it concluded its Phase 3 stage after enrolling 1629 participants. Since then, additional 21 investigational trials have reached completion."
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